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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: PRODUCT USE IN UNAPPROVED INDICATION

20250101 - 20251231

No. 1 - 100

Next page: 2 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
1
25491670
US
56 2
Pruritus, Neurodermatitis, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
2
25491895
US
47 2
Illness, Asthma, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
3
25491918
US
47 2
Rebound eczema, Pruritus, Dry skin, Therapeutic response shortened, Product use in unapproved indication,
DUPILUMAB,
4
25491927
PT
48 2
Venous thrombosis, Product use in unapproved indication,
SEMAGLUTIDE, PANTOPRAZOLE,
5
25491978
US
Erythema, Condition aggravated, Rash, Product use in unapproved indication,
CALCIPOTRIENE,
6
25491984
US
Product use in unapproved indication,
ALCLOMETASONE DIPROPIONATE,
7
25491988
US
58 2
Treatment failure, Product use in unapproved indication,
RILUZOLE, GABAPENTIN, MECLIZINE HCL 12.5 MG, MECLIZINE, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL 25MG, MECLIZINE HCL 12.5MG, DALFAMPRIDINE, BACLOFEN, ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE, BOTULINUM TOXIN TYPE A, AMANTADINE, MIRTAZAPINE, PANTOPRAZOLE, MODAFINIL, HUMAN IMMUNOGLOBULIN G, VORTIOXETINE, ROSUVASTATIN, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS,
8
25492039
US
2
Muscle spasms, Discomfort, Pain, Product use in unapproved indication, Insomnia,
9
25492168
CA
2
Pulmonary fibrosis, Pemphigus, Product use in unapproved indication, Psoriatic arthropathy, Pneumonia, Red blood cell sedimentation rate increased, Pericarditis, Pyrexia, Prescribed overdose, Prescribed underdose, Rash, Peripheral swelling,
ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, APREMILAST, ATOMOXETINE, ATOMOXETINE, CANDESARTAN, CELECOXIB, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CYCLOBENZAPRINE, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, METHOTREXATE, METHOTREXATE SODIUM, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, OXYCODONE, PANTOPRAZOLE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, RANITIDINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, TOFACITINIB, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, ACETAMINOPHEN AND CODEINE, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ERENUMAB-AOOE, RAMIPRIL, RAMIPRIL, RAMIPRIL, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, BOTULINUM TOXIN TYPE A, BUPRENORPHINE, BUPRENORPHINE, CALCIUM GLUCONATE, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CORTISONE ACETATE, SECUKINUMAB, CHLORHEXIDINE GLUCONATE, ANTISEPTIC SKIN CLEANSER, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, ETANERCEPT, AZELAIC ACID, ALENDRONATE SODIUM, ALENDRONATE SODIUM, GOLD, GOLIMUMAB, GOLIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, INFLIXIMAB, LAMOTRIGINE, LAMOTRIGINE, LAMOTRIGINE, SARILUMAB, LEVOMILNACIPRAN, MAGNESIUM CITRATE, MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON, LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, MIRABEGRON, MIRABEGRON, NAPROXEN, NAPROXEN SODIUM, MEPOLIZUMAB, ABATACEPT, ABATACEPT, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, PHENYLEPHRINE HYDROCHLORIDE, INFLIXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, GOLIMUMAB, TOCILIZUMAB, TOCILIZUMAB, TOFACITINIB, CELECOXIB,
10
25492414
CA
80 1
Appendicitis, Aortic stenosis, Ascites, Aspiration, Bronchiectasis, Bronchopulmonary aspergillosis allergic, Cardiogenic shock, Congenital hiatus hernia, Diabetes mellitus, End stage renal disease, Hypoxia, Lower respiratory tract infection, Malignant melanoma stage 0, Multiple organ dysfunction syndrome, Myasthenia gravis, Pulmonary embolism, Pulmonary fibrosis, Sepsis, Thrombosis, Ventricular fibrillation, Off label use, Incorrect route of product administration, Intentional product misuse, Product dose omission issue, Product use in unapproved indication,
INSULIN ASPART, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, ALLOPURINOL, AMIODARONE HYDROCHLORIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, HYDROCORTISONE ACETATE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, RAMIPRIL, RAMIPRIL, WARFARIN SODIUM, WARFARIN, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, SODIUM FERRIC GLUCONATE COMPLEX,
11
25492497
CA
Abdominal pain, Adjustment disorder with depressed mood, Amnesia, Anxiety, Asthma, Autoimmune disorder, Bursitis, Chest pain, Contusion, Decreased appetite, Deep vein thrombosis postoperative, Delirium, Discomfort, Dislocation of vertebra, Dyspnoea, Ear pain, Fatigue, Gastrointestinal disorder, Grip strength decreased, Headache, Hepatic enzyme, Hypersensitivity, Hypocholesterolaemia, Ill-defined disorder, Injury, Insomnia, Musculoskeletal pain, No adverse event, Osteoarthritis, Pericarditis, Peripheral swelling, Pruritus, Psoriatic arthropathy, Pyrexia, Rash, Sciatica, Sleep disorder due to general medical condition, insomnia type, Stomatitis, Systemic lupus erythematosus, Taste disorder, Urticaria, Wheezing, Adverse drug reaction, Infection, Sinusitis, Contraindicated product administered, Product use in unapproved indication,
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, APREMILAST, APREMILAST, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, CALCIUM CARBONATE, ANTACID, CELECOXIB, CELECOXIB, CELECOXIB, CERTOLIZUMAB PEGOL, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CHLORHEXIDINE GLUCONATE, ANTISEPTIC SKIN CLEANSER, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, SECUKINUMAB, SECUKINUMAB, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCYCLINE HYCLATE, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, GOLIMUMAB, GOLIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE SODIUM SUCCINATE, HYDROCORTISONE SODIUM SUCCINATE, HYDROCORTISONE SODIUM SUCCINATE, HYDROCORTISONE SODIUM SUCCINATE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, ISOPROPYL ALCOHOL, 70%ISOPROPYL ALCOHOL, ALCOHOL PREP PADS, ALCOHOL, ISOPROPYL ALCOHOL SPRAY, MAGNESIUM, NAPROXEN, NAPROXEN SODIUM, HAMAMELIS VIRGINIANA, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, RANITIDINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, LORAZEPAM, CYANOCOBALAMIN, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LANSOPRAZOLE, LISINOPRIL, LORAZEPAM, PANTOPRAZOLE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, QUETIAPINE FUMARATE, QUETIAPINE, RISEDRONATE SODIUM, SULFASALAZINE,
12
25492544
US
60 1
Product use in unapproved indication,
TEMOZOLOMIDE,
13
25492548
IT
75 2
Arteriospasm coronary, Product use in unapproved indication,
METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, OXYGEN, 0XYGEN, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, CHLORPHENIRAMINE MALEATE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, RAMIPRIL, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, EPINEPHRINE, ADRENALINUM, TICAGRELOR, NITROGLYCERIN, RIVAROXABAN,
14
25492558
US
1
Hip fracture, Product use in unapproved indication,
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
15
25492797
CN
37 1
Renal impairment, Hepatic function abnormal, Product use in unapproved indication,
DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCLYCLINE HYCLATE, DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCLYCLINE HYCLATE, RIFAMPIN, RIFAMPIN, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE,
16
25492821
CN
38 2
Neuropathy peripheral, Nicotinic acid deficiency, Vitamin B complex deficiency, Product use in unapproved indication,
RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE, ISONIAZID, PYRAZINAMIDE TABLET, PYRAZINAMIDE, CYCLOSERINE, RIFAPENTINE, PREDNISONE,
17
25492849
US
2 2
Cardiac failure congestive, Cardiotoxicity, Product use in unapproved indication, Product use issue,
CARBOPLATIN, METHOTREXATE, METHOTREXATE SODIUM, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
18
25493000
US
1
Hallucination, Hallucination, auditory, Liver injury, Product use in unapproved indication,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE,
19
25493018
CN
12 1
Osteonecrosis, Cauda equina syndrome, Neurotoxicity, Rhabdomyolysis, Toxicity to various agents, Acute kidney injury, Paralysis, Loss of consciousness, Pneumonia, Liver injury, Oedema, Sinus arrhythmia, Peroneal nerve injury, Posterior tibial nerve injury, Cough, Pain in extremity, Loss of proprioception, Sensory disturbance, Peroneal nerve palsy, Hyperreflexia, Tremor, Product use in unapproved indication,
CARBAMAZEPINE,
20
25493081
US
69 2
Mycobacterium avium complex infection, Condition aggravated, Drug resistance, Product use in unapproved indication,
RIFAMPIN, RIFAMPIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AMIKACIN,
21
25493104
US
83 2
Death, Product use in unapproved indication,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, MORPHINE, LORAZEPAM, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, DONEPEZIL HYDROCHLORIDE, GABAPENTIN, SERTRALINE, ERGOCALCIFEROL, OXYBUTYNIN CHLORIDE,
22
25493118
ES
24 2
Hepatocellular injury, Coagulopathy, Intentional overdose, Drug interaction, Product use in unapproved indication,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, NAPROXEN, NAPROXEN SODIUM,
23
25493231
US
2
Erythema, Pruritus, Skin burning sensation, Product use in unapproved indication,
NIRAPARIB, NIRAPARIB,
24
25493349
US
2
Disorientation, Product use in unapproved indication,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, VALBENAZINE,
25
25493354
US
2
Systemic lupus erythematosus, Product use in unapproved indication,
BELIMUMAB, BELIMUMAB, BELIMUMAB,
26
25493363
US
2
Product use in unapproved indication,
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, DIPHENHYDRAMINE HYDROCHLORIDE,
27
25493375
GB
Cognitive disorder, Deep vein thrombosis, Anaemia, Weight decreased, Intensive care unit acquired weakness, Haematuria traumatic, Liver function test abnormal, Fungal infection, Infection, Muscle contracture, Thrombophlebitis, Product use in unapproved indication, Off label use, Intentional product use issue,
ACYCLOVIR, LACOSAMIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, VALPROATE SODIUM, PHENYTOIN, TOPIRAMATE, TOPIRAMATE SPINKLE, PHENOBARBITAL, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PROPOFOL, PROPOFOL, CLONAZEPAM, CLOBAZAM, LORAZEPAM, FENTANYL, PERAMPANEL,
28
25493383
DE
76 1
Epistaxis, Somnolence, Product use in unapproved indication, Asthenia, General physical health deterioration,
PEMBROLIZUMAB, LENVATINIB,
29
25493384
US
Drug effective for unapproved indication, Product use in unapproved indication,
ACETAMINOPHEN, ASPIRIN, AND CAFFEINE,
30
25493610
US
27 2
Seizure, Loss of consciousness, Device breakage, Incorrect product administration duration, Product use in unapproved indication,
ETONOGESTREL, ETONOGESTREL,
31
25493679
CN
11 1
Cerebral venous sinus thrombosis, Cerebral infarction, Pneumonia, Upper respiratory tract infection, Product use in unapproved indication,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES,
32
25493746
CA
2
Pemphigus, Pericarditis, Peripheral swelling, Pneumonia, Psoriatic arthropathy, Pulmonary fibrosis, Pyrexia, Rash, Red blood cell sedimentation rate increased, Prescribed underdose, Off label use, Prescribed overdose, Product use in unapproved indication, Product use in unapproved indication,
ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ACETAMINOPHEN AND CODEINE, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ERENUMAB-AOOE, APREMILAST, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, ATOMOXETINE HYDROCHLORIDE, ATOMOXETINE HYDROCHLORIDE, BOTULINUM TOXIN TYPE A, BUPRENORPHINE, BUPRENORPHINE, CANDESARTAN, CELECOXIB, CELECOXIB, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CHLORHEXIDINE GLUCONATE, ANTISEPTIC SKIN CLEANSER, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CORTISONE ACETATE, SECUKINUMAB, CYCLOBENZAPRINE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, ETANERCEPT, AZELAIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, GOLD, GOLIMUMAB, GOLIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, INFLIXIMAB, SARILUMAB, LAMOTRIGINE, LAMOTRIGINE, LAMOTRIGINE, LAMOTRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEVOMILNACIPRAN, MAGNESIUM CITRATE, MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON, LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, MIRABEGRON, MIRABEGRON, NAPROXEN, NAPROXEN SODIUM, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, MEPOLIZUMAB, ABATACEPT, ABATACEPT, OXYCODONE, PANTOPRAZOLE, PHENYLEPHRINE HYDROCHLORIDE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, RAMIPRIL, RAMIPRIL, RAMIPRIL, RAMIPRIL, RANITIDINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, INFLIXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, GOLIMUMAB, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, TOCILIZUMAB, TOCILIZUMAB, TOFACITINIB, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TRAMADOL HYDROCHLORIDE, TOFACITINIB,
33
25493831
GB
2
Hepatitis, Liver function test abnormal, Hepatic steatosis, Product use in unapproved indication,
CLOZAPINE, CLOZAPINE,
34
25493873
US
37 1
Hospitalisation, Incorrect product administration duration, Product use in unapproved indication,
CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDE, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROCHLORIDE, MELATONIN,
35
25493987
US
82 1
Cardiac failure congestive, Blood pressure abnormal, Abnormal behaviour, Decreased appetite, Gait inability, Dyskinesia, Fatigue, Somnolence, Drug ineffective, Therapy interrupted, Product use in unapproved indication,
BREXPIPRAZOLE, BREXPIPRAZOLE, BREXPIPRAZOLE,
36
25494011
US
Injection site induration, Injection site swelling, Injection site erythema, Injection site pruritus, Product use in unapproved indication, Product preparation issue,
INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA,
37
25494053
CA
43 2
Blepharospasm, Contraindicated product administered, Decreased appetite, Drug ineffective, Epilepsy, Gastrooesophageal reflux disease, Hypoaesthesia, Malaise, Memory impairment, Migraine, Off label use, Pain, Product quality issue, Product use in unapproved indication, Rheumatic fever, Rheumatoid factor positive, Swollen joint count increased, Taste disorder, Treatment failure,
TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, CAFFEINE CITRATE, CALCIUM GLUCONATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LISINOPRIL, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, QUETIAPINE FUMARATE, QUETIAPINE, RISEDRONATE SODIUM,
38
25494060
US
Off label use, Product use in unapproved indication,
INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA,
39
25494078
US
59 2
Death, Drug effective for unapproved indication, Product use in unapproved indication, Vasospasm, Cerebral haemorrhage,
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN, NIMODIPINE, VASOPRESSIN, PROPOFOL, EPINEPHRINE, ADRENALINUM, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, CLEVIDIPINE,
40
25494420
CN
14 2
Initial insomnia, Depressed mood, Fatigue, Tearfulness, Product prescribing issue, Product use in unapproved indication,
DROSPIRENONE AND ETHINYL ESTRADIOL,
41
25494443
KR
2
Angioedema, Product use in unapproved indication,
CELECOXIB,
42
25494454
RO
72 1
Severe cutaneous adverse reaction, Product use in unapproved indication,
GABAPENTIN, GABAPENTIN, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, AMLODIPINE,
43
25494479
CN
42 2
Malignant neoplasm progression, Product use in unapproved indication, Brain oedema,
TEMOZOLOMIDE, BEVACIZUMAB,
44
25494497
US
25 2
Drug reaction with eosinophilia and systemic symptoms, Product use in unapproved indication,
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCYCLINE HYCLATE,
45
25494570
KR
2
Angioedema, Product use in unapproved indication,
CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB,
46
25494573
KR
2
Angioedema, Product use in unapproved indication,
CELECOXIB,
47
25494589
CN
55 1
Chest discomfort, Palpitations, Flushing, Pruritus, Oxygen saturation decreased, Rash, Product use in unapproved indication,
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS,
48
25494696
US
2
Hypersensitivity, Pruritus, Dyspnoea, Condition aggravated, Product use in unapproved indication, Intentional product misuse,
PERMETHRIN,
49
25494705
US
78 1
Pneumonitis, Product use in unapproved indication,
DAPTOMYCIN,
50
25494729
US
2
Hypersensitivity, Product use in unapproved indication,
51
25494992
US
16 1
Weight increased, Product use in unapproved indication,
LARONIDASE,
52
25495056
AU
64 1
Febrile neutropenia, Peripheral sensory neuropathy, Product use in unapproved indication, Drug ineffective,
FILGRASTIM, LENALIDOMIDE, LENALIDOMIDE, BRENTUXIMAB VEDOTIN,
53
25495065
US
Product prescribing issue, Product use in unapproved indication,
POLYETHYLENE GLYCOL 3350,
54
25495166
US
1
Drug effective for unapproved indication, Product administered at inappropriate site, Product use in unapproved indication,
DICLOFENAC SODIUM,
55
25495269
US
2
Product use in unapproved indication,
PEMBROLIZUMAB, CISPLATIN, ETOPOSIDE, LENVATINIB,
56
25495373
US
2
Intentional product misuse, Vaginal haemorrhage, Product use in unapproved indication,
LEVONORGESTREL,
57
25495375
US
2
Intentional product misuse, Back pain, Breast pain, Product use in unapproved indication,
LEVONORGESTREL,
58
25495382
US
23 2
Vaginal haemorrhage, Intentional product misuse, Product use in unapproved indication, Bacterial vaginosis, Vaginal odour, Pregnancy after post coital contraception, Drug ineffective,
LEVONORGESTREL,
59
25495384
US
27 2
Intentional product misuse, Vaginal haemorrhage, Product use in unapproved indication, Abdominal discomfort, Vaginal haemorrhage, Muscle spasms, Heavy menstrual bleeding,
LEVONORGESTREL, ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, NORGESTREL,
60
25495557
US
2
Depressed mood, Product use in unapproved indication,
DUPILUMAB, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, PANTOPRAZOLE, BUSPIRONE HYDROCHLORIDE, LAMOTRIGINE, LISINOPRIL, PRUCALOPRIDE, NALOXEGOL OXALATE, OXYCODONE HYDROCHLORIDE, OXYCODONE, PREGABALIN, PROPRANOLOL HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, TOPIRAMATE,
61
25495560
US
60 1
Drug ineffective, Product use in unapproved indication,
SARILUMAB,
62
25495565
US
2
Skin burning sensation, Pruritus, Rash, Product use in unapproved indication,
DUPILUMAB,
63
25495572
US
73 2
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication,
DUPILUMAB,
64
25495583
US
14 2
Injection site pain, Injection site erythema, Injection site swelling, Product use in unapproved indication, Product preparation error,
DUPILUMAB, DUPILUMAB,
65
25495591
US
2
Diarrhoea, Product use in unapproved indication,
SARILUMAB,
66
25495592
US
14 1
Product use in unapproved indication,
BELUMOSUDIL,
67
25495594
US
2
Injection site bruising, Product use in unapproved indication,
DUPILUMAB, PREGABALIN, VALSARTAN, VALSARTAN ORAL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, GABAPENTIN, PREDNISONE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
68
25495625
US
1
Ocular hyperaemia, Product use in unapproved indication,
DUPILUMAB,
69
25495649
US
9 1
Psoriasis, Product use in unapproved indication,
DUPILUMAB,
70
25495653
US
68 2
Gait disturbance, Pain, Activities of daily living decreased, Product use in unapproved indication,
DUPILUMAB,
71
25495676
US
48 1
Dermatitis contact, Condition aggravated, Neurodermatitis, Product use in unapproved indication, Intentional product misuse,
DUPILUMAB, DUPILUMAB,
72
25495696
US
54 1
Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
73
25495698
US
55 2
Paranasal sinus discomfort, Condition aggravated, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB, DUPILUMAB, DOXYCYCLINE, DOXYCYCLINE HYCLATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, ALBUTEROL SULFATE, ALBUTEROL, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, INSULIN GLARGINE, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE,
74
25495703
US
50 2
Product use in unapproved indication, Accidental exposure to product, Exposure via skin contact,
DUPILUMAB, DUPILUMAB,
75
25495706
US
54 2
Product use in unapproved indication,
DUPILUMAB, DUPILUMAB, DUPILUMAB,
76
25495711
US
5 2
Asthma, Product use in unapproved indication,
DUPILUMAB,
77
25495747
US
64 1
Cardiac ablation, Product use in unapproved indication, Incorrect dose administered,
DUPILUMAB, DUPILUMAB, DUPILUMAB, DUPILUMAB,
78
25495756
US
42 1
Rash erythematous, Skin burning sensation, Condition aggravated, Pruritus, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
79
25495770
US
2
Treatment failure, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB, DUPILUMAB,
80
25495772
US
62 2
Infection, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
81
25495794
US
16 2
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
82
25495803
US
83 2
Fatigue, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
83
25495815
US
89 2
Product use in unapproved indication,
DUPILUMAB,
84
25495823
US
19 2
Dry eye, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
85
25495843
US
44 2
Dermatitis atopic, Product use in unapproved indication,
DUPILUMAB,
86
25495848
US
64 2
Acne, Contusion, Paraesthesia, Pruritus, Product use in unapproved indication,
DUPILUMAB,
87
25495855
US
62 1
Injection site pain, Product preparation error, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
88
25495870
US
61 1
Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
89
25495879
US
23 2
Rebound eczema, Asthma, Product dose omission issue, Product use in unapproved indication,
DUPILUMAB,
90
25495980
US
46 2
Benign familial pemphigus, Condition aggravated, Product use in unapproved indication,
DUPILUMAB, DUPILUMAB,
91
25496064
US
27 2
Sjogren^s syndrome, Condition aggravated, Drug ineffective for unapproved indication, Product use in unapproved indication,
ERGOCALCIFEROL, NORGESTIMATE AND ETHINYL ESTRADIOL, PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION, HYDROXYCHLOROQUINE SULFATE, PREDNISONE, CERTOLIZUMAB PEGOL, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE,
92
25496100
US
72 2
Rebound eczema, Dry eye, Product use in unapproved indication,
DUPILUMAB,
93
25496128
8
Product use in unapproved indication, Acute graft versus host disease in liver, Acute graft versus host disease in skin, Drug ineffective, Cytomegalovirus infection, Acute graft versus host disease in intestine,
RUXOLITINIB, RUXOLITINIB, RUXOLITINIB, RUXOLITINIB, RUXOLITINIB, RUXOLITINIB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, BASILIXIMAB, BASILIXIMAB, BASILIXIMAB, BASILIXIMAB, BASILIXIMAB, BASILIXIMAB, CYCLOSPORINE, FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, THIOTEPA, BRINCIDOFOVIR, BRINCIDOFOVIR, GANCICLOVIR SODIUM, GANCICLOVIR, GANCICLOVIR SODIUM, GANCICLOVIR, CIDOFOVIR ANHYDROUS, CIDOFOVIR ANHYDROUS, FOSCARNET SODIUM, FOSCARNET SODIUM,
94
25496143
US
2
Vomiting, Intentional product misuse, Product use in unapproved indication,
LEVONORGESTREL,
95
25496155
US
19 2
Menstruation delayed, Dysmenorrhoea, Vaginal haemorrhage, Intentional product misuse, Product use in unapproved indication,
LEVONORGESTREL, NORETHINDRONE AND ETHINYL ESTRADIOL,
96
25496176
US
81 1
Renal failure, Product use in unapproved indication, Drug ineffective for unapproved indication, Diarrhoea,
MILTEFOSINE, SULFADIAZINE, VORICONAZOLE, FLUCYTOSINE,
97
25496244
CA
80 1
Myasthenia gravis, Iron deficiency, Nausea, Neuralgia, Incorrect route of product administration, Intentional product misuse, Off label use, Product use in unapproved indication,
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, DOBUTAMINE, DOBUTAMINE, DOBUTAMINE, GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, DOCUSATE SODIUM, DOCUSATE SODIUM 100MG, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, PHYTONADIONE, PHYTONADIONE, PHYTONADIONE,
98
25496299
US
Spinal meningioma benign, Malaise, Headache, Dyspnoea, Mobility decreased, Memory impairment, Product use in unapproved indication,
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, DROSPIRENONE AND ETHINYL ESTRADIOL,
99
25496302
US
53 1
Injection site rash, Product use in unapproved indication,
DUPILUMAB,
100
25496391
US
70 2
Product use in unapproved indication, Extra dose administered,
DUPILUMAB, DUPILUMAB, DONEPEZIL HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE, HYDROXYZINE, LOSARTAN, EVOLOCUMAB, TIZANIDINE,

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Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.

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license

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last_updated

2025-07-29

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