Drug:
Reaction: PRODUCT USE IN UNAPPROVED INDICATION
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
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Drug (openfda.generic_name, medicinalproduct) |
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| 1 | 25138788 |
CA |
41 | 2 |
Angioedema, Dysphonia, Product use in unapproved indication, Drug intolerance, Headache, Hypersensitivity, Swelling face, Swollen tongue, Drug ineffective, |
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ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, AMOXICILLIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE, CLARITHROMYCIN, CLARITHROMYCIN, CLARITHROMYCIN, CLARITHROMYCIN, ZOLMITRIPTAN, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, FLUCONAZOLE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, SCOPOLAMINE, SCOPOLAMINE, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, INDOMETHACIN, LANSOPRAZOLE, LISINOPRIL, LISINOPRIL, METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE, MOMETASONE FUROATE, MOMETASONE, MOMETASONE FUROATE, MOMETASONE, MOMETASONE FUROATE, MOMETASONE, MOMETASONE FUROATE, MOMETASONE, MOMETASONE FUROATE, MOMETASONE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RABEPRAZOLE SODIUM, RABEPRAZOLE, RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE, PREDNISONE, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, SERTRALINE HYDROCHLORIDE, SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, TOPIRAMATE, TOPIRAMATE SPINKLE, TRIMETHOPRIM, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, LISINOPRIL, LISINOPRIL, LISINOPRIL, PREDNISONE, PREDNISONE, AZITHROMYCIN DIHYDRATE, CEFUROXIME AXETIL, CEFUROXIME AXETIL, CEPHALEXIN, CEPHALEXIN, DANAZOL, DANAZOL, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, FROVATRIPTAN SUCCINATE, MOMETASONE FUROATE, MOMETASONE, METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE, METRONIDAZOLE, METRONIDAZOLE TOPICAL, MORPHINE SULFATE, NAPROXEN, NAPROXEN SODIUM, MOMETASONE FUROATE, OSELTAMIVIR, OSELTAMIVIR PHOSPHATE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ALBUTEROL SULFATE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, ACETAMINOPHEN AND CODEINE, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE, NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, |
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| 2 | 25138823 |
US |
59 | 1 |
Eye pruritus, Condition aggravated, Product use in unapproved indication, |
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DUPILUMAB, DUPILUMAB, DUPILUMAB, |
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| 3 | 25138841 |
US |
6 | 2 |
Product use in unapproved indication, Swelling face, Oral herpes, Hypersensitivity, Tension, Product use complaint, |
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DUPILUMAB, DUPILUMAB, DUPILUMAB, DUPILUMAB, |
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| 4 | 25138843 |
US |
2 | |
Pain in extremity, Arthralgia, Product use in unapproved indication, |
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DUPILUMAB, DUPILUMAB, GUAIFENESIN, FLUTICASONE PROPIONATE, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, |
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| 5 | 25138949 |
US |
67 | 1 |
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication, |
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DUPILUMAB, |
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| 6 | 25139047 |
US |
||
Insomnia, Drug ineffective, Feeling abnormal, Product use in unapproved indication, |
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| 7 | 25139060 |
US |
47 | 2 |
Pain, Erythema, Pruritus, Skin burning sensation, Product use in unapproved indication, |
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DUPILUMAB, |
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| 8 | 25139191 |
FR |
31 | 2 |
Anaphylactic reaction, Adverse event, Drug ineffective, Product use in unapproved indication, |
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EZETIMIBE, URSODIOL, URSOSIOL, |
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| 9 | 25139232 |
US |
63 | 1 |
Product use in unapproved indication, |
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DAPTOMYCIN, CEFTRIAXONE, CEFTRIAXONE SODIUM, |
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| 10 | 25139395 |
US |
||
Granuloma, Product use in unapproved indication, |
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BACLOFEN INJECTION, BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE IN DEXTROSE, |
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| 11 | 25139542 |
US |
1 | 1 |
Pericarditis, Condition aggravated, Dermatitis atopic, Product use in unapproved indication, |
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DUPILUMAB, DUPILUMAB, |
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| 12 | 25139722 |
FR |
2 | |
Enteritis, Pain, Incorrect dose administered, Product use in unapproved indication, |
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SACITUZUMAB GOVITECAN, |
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| 13 | 25139736 |
JP |
57 | 2 |
Calcineurin inhibitor induced pain syndrome, Drug interaction, Immunosuppressant drug level increased, Product use in unapproved indication, |
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TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, CLARITHROMYCIN, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, TOCILIZUMAB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, |
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| 14 | 25139877 |
US |
47 | 1 |
Product use in unapproved indication, Therapeutic response unexpected, |
||||
| 15 | 25139957 |
27 | 2 | |
Lupus-like syndrome, Product use in unapproved indication, |
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LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 16 | 25140017 |
US |
||
Drug dose omission by device, Product use in unapproved indication, Wrong technique in product usage process, No adverse event, |
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ALBUTEROL SULFATE, |
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| 17 | 25140028 |
US |
2 | 1 |
Ear infection, Product use in unapproved indication, |
||||
TROFINETIDE, |
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| 18 | 25140263 |
US |
1 | |
Product use in unapproved indication, |
||||
PIMAVANSERIN TARTRATE, |
||||
| 19 | 25140347 |
US |
2 | |
Product use in unapproved indication, |
||||
VORINOSTAT, CYTARABINE, |
||||
| 20 | 25140357 |
JP |
12 | 1 |
Dermatomyositis, Disease progression, Off label use, Product use in unapproved indication, |
||||
CYCLOSPORINE, METHOTREXATE, METHOTREXATE SODIUM, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, METHYLPREDNISOLONE, |
||||
| 21 | 25140606 |
US |
1 | |
Drug ineffective, Product use in unapproved indication, |
||||
MEPOLIZUMAB, |
||||
| 22 | 25140681 |
US |
39 | 1 |
Product use in unapproved indication, Product prescribing issue, |
||||
PRAZIQUANTEL, |
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| 23 | 25140714 |
US |
||
Injection site scar, Injection site mass, Injection site erythema, Injection site pruritus, Product use in unapproved indication, |
||||
| 24 | 25140869 |
US |
||
Product use in unapproved indication, Therapeutic response unexpected, |
||||
CETIRIZINE HYDROCHLORIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, |
||||
| 25 | 25141015 |
US |
69 | 2 |
Derealisation, Poisoning, General physical health deterioration, Movement disorder, Illness, Visual impairment, Gait disturbance, Pain, Crying, Burning sensation, Hepatic enzyme abnormal, Suspected counterfeit product, Expired product administered, Product use in unapproved indication, |
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TINIDAZOLE, |
||||
| 26 | 25141143 |
US |
||
Product use in unapproved indication, |
||||
C1 ESTERASE INHIBITOR RECOMBINANT, |
||||
| 27 | 25141308 |
US |
||
Respiration abnormal, Spinal fracture, Nephrolithiasis, Multiple allergies, Musculoskeletal stiffness, Dyspnoea, Chest discomfort, Product use in unapproved indication, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 28 | 25141366 |
ES |
||
Generalised oedema, Weight increased, Drug interaction, Product use in unapproved indication, |
||||
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, |
||||
| 29 | 25141370 |
US |
2 | |
Premature delivery, Product use in unapproved indication, Product prescribing issue, |
||||
ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 30 | 25141436 |
US |
54 | 2 |
Sleep disorder due to a general medical condition, Product use in unapproved indication, |
||||
DUPILUMAB, TRETINOIN, |
||||
| 31 | 25141440 |
US |
47 | 1 |
Urticaria, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 32 | 25141475 |
US |
1 | |
Injection site vesicles, Injection site erythema, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 33 | 25141481 |
US |
2 | |
Illness, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 34 | 25141500 |
US |
58 | 2 |
Rash erythematous, Psoriasis, Skin haemorrhage, Skin burning sensation, Pruritus, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 35 | 25141510 |
US |
20 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 36 | 25141519 |
US |
42 | 1 |
Eczema, Drug ineffective, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 37 | 25141525 |
US |
41 | 2 |
Psoriasis, Skin disorder, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 38 | 25141553 |
US |
2 | |
Eye pruritus, Lacrimation increased, Injection site swelling, Product use in unapproved indication, |
||||
SARILUMAB, LISINOPRIL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, |
||||
| 39 | 25141564 |
US |
58 | 2 |
Movement disorder, Gait inability, Pain, Malaise, Product use in unapproved indication, |
||||
SARILUMAB, SARILUMAB, INFLIXIMAB-AXXQ, |
||||
| 40 | 25141573 |
US |
21 | 2 |
Swelling face, Product use in unapproved indication, |
||||
CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, PREDNISONE, |
||||
| 41 | 25141630 |
US |
15 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 42 | 25141632 |
US |
76 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 43 | 25141769 |
CA |
43 | 2 |
Asthenia, Blood cholesterol increased, Drug ineffective, Exposure during pregnancy, Hypertension, Liver function test increased, Liver injury, Maternal exposure during pregnancy, Memory impairment, Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Nausea, Oedema, Off label use, Pain, Pain in extremity, Pemphigus, Pericarditis, Peripheral swelling, Prescribed overdose, Product use in unapproved indication, Product use issue, Psoriatic arthropathy, Rash, Rheumatic fever, Rheumatoid arthritis, Rheumatoid factor positive, Seronegative arthritis, Sleep disorder, Swelling, Spondylitis, Swollen joint count increased, Synovitis, Systemic lupus erythematosus, Therapeutic product effect decreased, Treatment failure, Type 2 diabetes mellitus, Vomiting, Weight decreased, Wheezing, Wound, Wound infection, |
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OXYCODONE HYDROCHLORIDE, OXYCODONE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, APREMILAST, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, CALCIUM CARBONATE, ANTACID, CELECOXIB, CELECOXIB, CELECOXIB, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, SECUKINUMAB, 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%, ETANERCEPT, ETANERCEPT, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, FOLIC ACID, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, GOLIMUMAB, GOLIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, ADALIMUMAB-ADAZ, INFLIXIMAB, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, 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, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, HYDROXYCHLOROQUINE SULFATE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, INFLIXIMAB, RITUXIMAB, RITUXIMAB, GOLIMUMAB, GOLIMUMAB, USTEKINUMAB, USTEKINUMAB, 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, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, AZATHIOPRINE, ERYTHROMYCIN, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LISINOPRIL, LISINOPRIL, MAGNESIUM, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, QUETIAPINE FUMARATE, QUETIAPINE, RAMIPRIL, RISEDRONATE SODIUM, SULFASALAZINE, |
||||
| 44 | 25142041 |
US |
88 | |
Dyspnoea, Drug dose omission by device, Product use in unapproved indication, Wrong technique in product usage process, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 45 | 25142064 |
US |
2 | |
Drug ineffective, Product use in unapproved indication, |
||||
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, |
||||
| 46 | 25142158 |
CA |
53 | 1 |
Bronchiectasis, Deep vein thrombosis, Haematochezia, Pulmonary embolism, Rectal haemorrhage, Tubulointerstitial nephritis, Cerebrovascular accident, Adverse drug reaction, Burns second degree, Cardiac murmur, Catarrh, Confusional state, Depression, Steroid dependence, Parosmia, Dysgeusia, Arthritis, Swollen tongue, Gingival pain, Stress, Hypopnoea, Tinnitus, Weight decreased, Impaired quality of life, Impaired work ability, Loss of personal independence in daily activities, Migraine, Nightmare, Somnolence, Vertigo, Eczema, Palpitations, Abdominal discomfort, Pain, Systemic lupus erythematosus, Pyrexia, Colitis ulcerative, Pain in extremity, Frequent bowel movements, Rash, Rhinitis, COVID-19, Fatigue, Headache, Condition aggravated, Drug ineffective, Medication error, Off label use, Inappropriate schedule of product administration, Intentional product use issue, Product use in unapproved indication, Accidental overdose, |
||||
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ALBENDAZOLE, ALBENDAZOLE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, DAPAGLIFLOZIN, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, FUROSEMIDE, GABAPENTIN, 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, 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, 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, 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, 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, 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, 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, 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, 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, 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, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OXYCODONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, ROSUVASTATIN, ROSUVASTATIN, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, ERGOCALCIFEROL, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, CANDESARTAN, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, MESALAMINE, VEDOLIZUMAB, VEDOLIZUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, EPINEPHRINE, ADRENALINUM, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, LISDEXAMFETAMINE DIMESYLATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CANDESARTAN CILEXETIL, ROSUVASTATIN, ROSUVASTATIN, ROSUVASTATIN, LEVOTHYROXINE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, OXYCODONE HYDROCHLORIDE, OXYCODONE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE, FESOTERODINE FUMARATE, FOLIC ACID, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, LATANOPROST, LATANOPROST, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, RAMIPRIL, RIVAROXABAN, TAMSULOSIN HYDROCHLORIDE, TOFACITINIB, TOFACITINIB, MINERAL OIL, NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), TETRAHYDROZOLINE HYDROCHLORIDE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, LANSOPRAZOLE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, EMPAGLIFLOZIN, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, DORZOLAMIDE, PREGABALIN, MINERAL OIL, NAPHAZOLINE HYDROCHLORIDE, AMLODIPINE, AMLODIPINE, TETRAHYDROZOLINE HYDROCHLORIDE, |
||||
| 47 | 25142384 |
US |
2 | |
Drug ineffective, Product use in unapproved indication, |
||||
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, |
||||
| 48 | 25142391 |
US |
||
Drug ineffective, Product use in unapproved indication, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 49 | 25142404 |
US |
81 | 1 |
Death, Product use in unapproved indication, |
||||
BREXPIPRAZOLE, BREXPIPRAZOLE, BREXPIPRAZOLE, |
||||
| 50 | 25142422 |
US |
||
Drug effect less than expected, Product use in unapproved indication, |
||||
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, |
||||
| 51 | 25142525 |
US |
2 | |
Product use in unapproved indication, |
||||
SARILUMAB, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, PREDNISONE, TOPIRAMATE, TOPIRAMATE SPINKLE, |
||||
| 52 | 25138183 |
IN |
48 | 2 |
Leukoencephalopathy, Product use in unapproved indication, |
||||
METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 53 | 25138187 |
PT |
51 | 1 |
Face oedema, Product use in unapproved indication, Drug interaction, |
||||
PREGABALIN, PREGABALIN, FENTANYL, MORPHINE SULFATE, CLONAZEPAM, SENNOSIDES, SENNA LEAF, SENNA, |
||||
| 54 | 25138192 |
CZ |
57 | 1 |
Acute psychosis, Product use in unapproved indication, |
||||
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, CLARITHROMYCIN, |
||||
| 55 | 25138203 |
US |
41 | 1 |
Dermatitis, Off label use, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 56 | 25138206 |
US |
49 | 2 |
Fatigue, Nausea, Product use in unapproved indication, |
||||
SARILUMAB, SARILUMAB, SARILUMAB, SARILUMAB, |
||||
| 57 | 25138308 |
US |
48 | 2 |
Dermatitis, Seasonal allergy, Dry skin, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 58 | 25138501 |
US |
16 | 1 |
Asthma, Cough, Dyspnoea, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 59 | 25138591 |
US |
2 | |
Condition aggravated, Fracture, Dyspnoea, Chest pain, Urinary tract infection, Cardiac disorder, Hip fracture, Upper limb fracture, Loss of personal independence in daily activities, Pain in extremity, Muscle spasms, Sternal fracture, Intentional dose omission, Fatigue, Constipation, Sleep disorder, Abdominal pain upper, Back pain, Product use in unapproved indication, Product dose omission in error, |
||||
ABALOPARATIDE, DILTIAZEM HYDROCHLORIDE, OXYCODONE, TORSEMIDE, ELEXACAFTOR, TEZACAFTOR, AND IVACAFTOR, SACUBITRIL AND VALSARTAN, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, PANCRELIPASE, |
||||
| 60 | 25138636 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 61 | 25138668 |
US |
1 | |
Productive cough, Arthralgia, Product use in unapproved indication, |
||||
DUPILUMAB, ALBUTEROL SULFATE, CARVEDILOL, DOXYCYCLINE, DOXYCYCLINE HYCLATE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM, LOSARTAN, AMLODIPINE BESYLATE, |
||||
| 62 | 25138674 |
US |
61 | 2 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 63 | 25137228 |
US |
51 | 2 |
Skin fissures, Psoriasis, Dermatitis atopic, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 64 | 25137234 |
US |
||
Abdominal pain upper, Product use in unapproved indication, |
||||
LURASIDONE HYDROCHLORIDE, |
||||
| 65 | 25137259 |
CA |
40 | 1 |
Disinhibition, Antipsychotic drug level below therapeutic, Obsessive-compulsive disorder, Toxicity to various agents, Schizoaffective disorder, Irritability, Prescribed overdose, Off label use, Dyslipidaemia, Leukaemia, Product use in unapproved indication, Obesity, Suicide attempt, Euphoric mood, Akathisia, Increased appetite, Leukopenia, Weight increased, Therapeutic product effect incomplete, Therapeutic product effect variable, Drug ineffective, Hypertension, |
||||
CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, ASENAPINE MALEATE, ASENAPINE MALEATE, FLUOXETINE HYDROCHLORIDE, AMISULPRIDE, AMISULPRIDE, CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE CAPSULES, CLOZAPINE, GABAPENTIN, GABAPENTIN, GABAPENTIN, HALOPERIDOL, HALOPERIDOL LACTATE, HALOPERIDOL, HALOPERIDOL LACTATE, HALOPERIDOL, HALOPERIDOL LACTATE, LITHIUM CARBONATE, LITHIUM CARBONATE, LITHIUM CARBONATE, LITHIUM, LITHIUM BROMATUM, LITHIUM, LITHIUM BROMATUM, LITHIUM, LITHIUM BROMATUM, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, PERPHENAZINE, PERPHENAZINE, PERPHENAZINE, PERPHENAZINE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, FLUOXETINE HYDROCHLORIDE, ZIPRASIDONE, ARIPIPRAZOLE, VALPROATE SODIUM, VALPROATE SODIUM, OLANZAPINE, ZIPRASIDONE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, LOXAPINE, ZIPRASIDONE MESYLATE, |
||||
| 66 | 25137318 |
US |
2 | |
Hyperkeratosis, Nail disorder, Nail discolouration, Product use in unapproved indication, Drug ineffective for unapproved indication, Product prescribing issue, |
||||
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, ANASTROZOLE, ANASTROZOLE TABLETS, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LISINOPRIL, |
||||
| 67 | 25137368 |
US |
50 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 68 | 25137370 |
US |
14 | 2 |
Anxiety, Intentional dose omission, Rebound eczema, Pruritus, Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 69 | 25137426 |
US |
76 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 70 | 25137498 |
US |
82 | 1 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 71 | 25137529 |
US |
25 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 72 | 25137710 |
GB |
||
Cardiac arrest, Arrhythmia, Brain hypoxia, Product use in unapproved indication, |
||||
ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, |
||||
| 73 | 25137826 |
US |
||
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 74 | 25137841 |
DE |
52 | 2 |
Syncope, Lacrimation increased, Urinary incontinence, Lacrimation increased, Salivary hypersecretion, Hunger, Product use in unapproved indication, Condition aggravated, Somnolence, Anal incontinence, Bradyphrenia, Thirst, Dizziness, Psoriasis, Tongue movement disturbance, Vision blurred, Decreased interest, Contusion, Fatigue, Behaviour disorder, Muscle spasms, Bruxism, Heart rate increased, Food craving, Skin disorder, Spider vein, Decreased appetite, Tinnitus, Hyperhidrosis, Rhinorrhoea, Hypoaesthesia, Accommodation disorder, |
||||
CARIPRAZINE, CARIPRAZINE, CARIPRAZINE, BISOPROLOL FUMARATE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, LORAZEPAM, |
||||
| 75 | 25137889 |
US |
38 | 2 |
Illness, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 76 | 25137976 |
US |
1 | |
Weight decreased, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, PITAVASTATIN CALCIUM, PITAVASTATIN, FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE ORAL, FEXOFENADINE HCL, TAMSULOSIN HYDROCHLORIDE, LEFLUNOMIDE, SPIRONOLACTONE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, SIMVASTATIN, |
||||
| 77 | 25132094 |
US |
82 | 2 |
Drug effective for unapproved indication, Drug ineffective for unapproved indication, Product use in unapproved indication, Product administered at inappropriate site, |
||||
DICLOFENAC SODIUM, DICLOFENAC SODIUM, |
||||
| 78 | 25132109 |
2 | ||
Adverse drug reaction, Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 79 | 25132111 |
2 | ||
Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, |
||||
| 80 | 25132115 |
2 | ||
Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 81 | 25132118 |
2 | ||
Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 82 | 25132440 |
CA |
70 | 2 |
Pneumonia, Product use in unapproved indication, |
||||
AVACOPAN, |
||||
| 83 | 25132493 |
US |
66 | 2 |
Nasal congestion, Oropharyngeal discomfort, Cough, Product use in unapproved indication, |
||||
DUPILUMAB, UPADACITINIB, |
||||
| 84 | 25132532 |
US |
2 | |
Adverse drug reaction, Product use in unapproved indication, |
||||
RIFAMPIN, |
||||
| 85 | 25132558 |
US |
62 | 2 |
Nausea, Product use in unapproved indication, |
||||
RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AMIKACIN, AMIKACIN, LINEZOLID, MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN, |
||||
| 86 | 25132576 |
US |
62 | 2 |
Dacryostenosis acquired, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, SEMAGLUTIDE, |
||||
| 87 | 25132584 |
US |
70 | 2 |
Drug interaction, Product use in unapproved indication, |
||||
RIFAMPIN, RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AMIKACIN, AMIKACIN, |
||||
| 88 | 25132634 |
US |
64 | 2 |
Eye disorder, Lip disorder, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DENOSUMAB, |
||||
| 89 | 25132701 |
US |
30 | 1 |
Therapeutic response unexpected, Product use in unapproved indication, Incorrect route of product administration, |
||||
CETIRIZINE HYDROCHLORIDE, GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDE, |
||||
| 90 | 25132702 |
US |
77 | 1 |
Pneumonia, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 91 | 25132864 |
59 | 2 | |
Therapeutic product effect variable, Product use in unapproved indication, |
||||
SOLRIAMFETOL, SOLRIAMFETOL, FOLIC ACID, IRON, GABAPENTIN, CYCLOBENZAPRINE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), |
||||
| 92 | 25132879 |
2 | ||
Drug effect less than expected, Adverse drug reaction, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 93 | 25132880 |
2 | ||
Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 94 | 25132881 |
2 | ||
Drug effect less than expected, Adverse drug reaction, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 95 | 25132882 |
2 | ||
Adverse drug reaction, Drug effect less than expected, Product use in unapproved indication, |
||||
SOLRIAMFETOL, |
||||
| 96 | 25132914 |
US |
84 | 1 |
Pancytopenia, Sepsis, Product use in unapproved indication, |
||||
DOXORUBICIN, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, RITUXIMAB, ETOPOSIDE, PREDNISONE, |
||||
| 97 | 25132915 |
AU |
69 | 1 |
Optic ischaemic neuropathy, Product use in unapproved indication, |
||||
SEMAGLUTIDE, |
||||
| 98 | 25133042 |
US |
92 | 2 |
Overdose, Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, |
||||
| 99 | 25133152 |
US |
||
Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, |
||||
| 100 | 25133237 |
US |
67 | 2 |
Seizure, Seizure, Weight increased, Product use in unapproved indication, |
||||
SEMAGLUTIDE, SEMAGLUTIDE, |
||||
disclaimer
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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last_updated
2025-04-28