Drug:
Reaction: PRODUCT USE IN UNAPPROVED INDICATION
20260101 - 20261231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 26545913 |
US |
37 | |
Product use in unapproved indication, |
||||
INCOBOTULINUMTOXINA, |
||||
| 302 | 26545998 |
75 | 2 | |
Product use in unapproved indication, Product prescribing issue, |
||||
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350, |
||||
| 303 | 26546014 |
US |
23 | 2 |
Product use in unapproved indication, Pruritus, Skin haemorrhage, Skin weeping, Skin fissures, Dry skin, Eczema, Skin exfoliation, |
||||
DUPILUMAB, |
||||
| 304 | 26546019 |
US |
70 | 2 |
Wrist fracture, Fall, Product use in unapproved indication, |
||||
DUPILUMAB, TERIPARATIDE, |
||||
| 305 | 26546085 |
US |
80 | 2 |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 306 | 26546090 |
US |
66 | 2 |
Urticaria, Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 307 | 26546091 |
US |
43 | 2 |
Injection site hypersensitivity, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 308 | 26546314 |
US |
69 | 1 |
Product use in unapproved indication, |
||||
PEMBROLIZUMAB, PEMBROLIZUMAB, |
||||
| 309 | 26546668 |
US |
48 | 2 |
Product use in unapproved indication, Product use issue, |
||||
TEMOZOLOMIDE, LENVATINIB, PEMBROLIZUMAB, |
||||
| 310 | 26535973 |
|||
Cardiac arrest, Product use in unapproved indication, |
||||
CERTOLIZUMAB PEGOL, |
||||
| 311 | 26536227 |
US |
2 | |
Product dose omission issue, Product use in unapproved indication, No adverse event, |
||||
DUPILUMAB, DUPILUMAB, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 312 | 26536237 |
PH |
20 | 1 |
Septic shock, Product use in unapproved indication, Neutropenia, Neutropenic colitis, |
||||
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, METHOTREXATE, METHOTREXATE SODIUM, RITUXIMAB, MERCAPTOPURINE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, VINCRISTINE SULFATE, |
||||
| 313 | 26536249 |
US |
62 | 2 |
Methaemoglobinaemia, Product use in unapproved indication, Drug interaction, |
||||
HYDROXYCHLOROQUINE SULFATE, DAPSONE GEL, 5%, DAPSONE, DASPONE, IVERMECTIN, DOXYCYCLINE, DOXYCYCLINE HYCLATE, RIFAMPIN, |
||||
| 314 | 26536668 |
US |
72 | 2 |
Lip swelling, Lip pain, Intention tremor, Tremor, Sinus congestion, Cough, Rash, Dizziness, Hypersensitivity, Headache, Nausea, Candida infection, Treatment failure, Product use in unapproved indication, |
||||
RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AMLODIPINE, CARVEDILOL, CELECOXIB, FLUCONAZOLE, GABAPENTIN, HYDROCHLOROTHIAZIDE, LATANOPROST, ENSIFENTRINE, PANTOPRAZOLE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE NASAL, PREDNISONE, PREDNISONE, PREDNISONE, ALBUTEROL SULFATE, ITRACONAZOLE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, DENOSUMAB, MINOCYCLINE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, RIFABUTIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, CEFEPIME HYDROCHLORIDE, CEFEPIME, ISAVUCONAZONIUM SULFATE, VORICONAZOLE, VORICONAZOLE INJECTION, |
||||
| 315 | 26536746 |
US |
2 | |
Drug intolerance, Adverse drug reaction, Drug resistance, Product use in unapproved indication, |
||||
RIFAMPIN, ETHAMBUTOL HYDROCHLORIDE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, |
||||
| 316 | 26536750 |
US |
2 | |
Fall, Product use in unapproved indication, |
||||
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, TOCILIZUMAB, |
||||
| 317 | 26536879 |
EU |
72 | 1 |
Lymphoma, Disease progression, T-cell prolymphocytic leukaemia, Product use in unapproved indication, |
||||
ALEMTUZUMAB, |
||||
| 318 | 26536880 |
US |
33 | 2 |
Intrapartum haemorrhage, Exposure during pregnancy, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 319 | 26537027 |
US |
88 | 2 |
Death, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 320 | 26537074 |
US |
89 | 2 |
Death, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 321 | 26537085 |
US |
72 | 1 |
Neoplasm malignant, Cardiac disorder, Pain in extremity, Product use in unapproved indication, |
||||
SARILUMAB, SARILUMAB, |
||||
| 322 | 26537088 |
US |
72 | 2 |
Death, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 323 | 26537133 |
CA |
75 | 2 |
Product use in unapproved indication, Toxic epidermal necrolysis, Haemoglobin decreased, Rash erythematous, Rash papular, Epidermal necrosis, Nikolsky^s sign positive, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CALCIUM CARBONATE, ANTACID, DICLOFENAC, DICLOFENAC SODIUM, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LATANOPROST, LATANOPROST, LATANOPROST, NAPROXEN, NAPROXEN SODIUM, PREGABALIN, BRINZOLAMIDE, TELMISARTAN, TELMISARTAN, CLONAZEPAM, BRINZOLAMIDE, BRINZOLAMIDE, ERGOCALCIFEROL, ERGOCALCIFEROL, GABAPENTIN, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, 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%, PREGABALIN, LATANOPROST, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, VITAMIN C, VITAMIN A, ERGOCALCIFEROL, ERGOCALCIFEROL, NICOTINAMIDE, CALCIUM CARBONATE, THIAMINE HYDROCHLORIDE, DEXPANTHENOL, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, TELMISARTAN, TELMISARTAN, DICLOFENAC SODIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, AMOXICILLIN, DICLOFENAC, DICLOFENAC SODIUM, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN AND CODEINE, |
||||
| 324 | 26537305 |
CN |
42 | 1 |
Product use in unapproved indication, Myelosuppression, Hyponatraemia, Pyrexia, Diarrhoea, Temperature intolerance, Chills, |
||||
TRASTUZUMAB, GEMCITABINE HYDROCHLORIDE, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), |
||||
| 325 | 26537344 |
GB |
29 | 1 |
Irritable bowel syndrome, Abdominal pain, Colitis, Inflammation, Diarrhoea haemorrhagic, Ulcer, Product use in unapproved indication, |
||||
DUPILUMAB, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, METHYLPREDNISOLONE, INFLIXIMAB, |
||||
| 326 | 26537730 |
US |
87 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 327 | 26537807 |
US |
52 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 328 | 26537887 |
US |
2 | |
Swelling, Pruritus, Erythema, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, CALCIUM, ERGOCALCIFEROL, VITAMIN A, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, NEMOLIZUMAB-ILTO, |
||||
| 329 | 26537889 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 330 | 26537893 |
US |
67 | 1 |
Conjunctivitis, Skin haemorrhage, Dry skin, Pruritus, Blood cholesterol decreased, Product use in unapproved indication, |
||||
DUPILUMAB, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, |
||||
| 331 | 26537975 |
US |
87 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 332 | 26537991 |
CA |
43 | 2 |
Type 2 diabetes mellitus, Abdominal pain, Abdominal pain upper, Adverse event, Alopecia, Anti-cyclic citrullinated peptide antibody positive, Anxiety, Arthralgia, Arthropathy, Blister, Breast cancer stage III, Chest pain, Condition aggravated, Decreased appetite, Diarrhoea, Disability, Dizziness, Duodenal ulcer perforation, Dyspnoea, Nausea, Pruritus, Osteoarthritis, Pneumonia, Product use issue, Fatigue, Bronchitis, Grip strength decreased, Oedema, Drug hypersensitivity, Seronegative arthritis, Gait disturbance, Intentional product use issue, Insomnia, Adverse drug reaction, Therapeutic product effect incomplete, Amnesia, Therapeutic response decreased, Pyrexia, Treatment failure, Adjustment disorder with depressed mood, Liver function test increased, Muscular weakness, Dislocation of vertebra, Therapeutic product effect decreased, Upper respiratory tract infection, Hepatic enzyme increased, Foot deformity, Sciatica, Spondylitis, Mobility decreased, Oedema peripheral, Musculoskeletal stiffness, Rheumatic fever, Injury, Joint dislocation, Sinusitis, Headache, Swollen joint count increased, Delirium, Visual impairment, Weight decreased, C-reactive protein increased, Hypersensitivity, Osteoporosis, Discomfort, Tachycardia, Hypertension, Contraindicated product administered, Joint range of motion decreased, Drug tolerance decreased, Retinitis, Blood cholesterol increased, Depression, Drug-induced liver injury, Drug ineffective, Vomiting, Helicobacter infection, Hypoaesthesia, Infection, Infusion related reaction, Joint swelling, Live birth, Liver injury, Malaise, Maternal exposure during pregnancy, Memory impairment, Muscle injury, Off label use, Pain, Pemphigus, Pericarditis, Peripheral swelling, Product use in unapproved indication, Psoriasis, Psoriatic arthropathy, Rash, Rheumatoid arthritis, Abdominal discomfort, Walking aid user, Wheezing, Wound, Wound infection, Exposure during pregnancy, Fibromyalgia, General physical health deterioration, Glossodynia, Hand deformity, Prescribed overdose, Rheumatoid factor positive, Sleep disorder, Swelling, Synovitis, Systemic lupus erythematosus, Therapy non-responder, Treatment noncompliance, |
||||
DICLOFENAC SODIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM, DICLOFENAC SODIUM, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, CANDESARTAN, CANDESARTAN, 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, 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, OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE, 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, 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, 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, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, 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%, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, 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%, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, 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%, ERENUMAB-AOOE, ERENUMAB-AOOE, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, CALCIUM CARBONATE, CALCIUM CARBONATE, CALCIUM CARBONATE, CALCIUM CARBONATE, SARILUMAB, PREGABALIN, PREGABALIN, PREDNISONE, TRIPROLIDINE HYDROCHLORIDE, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, GOLIMUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, 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, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, TOFACITINIB, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, OXYCODONE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, VITAMIN C, 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, LEFLUNOMIDE, LEFLUNOMIDE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL, FOLIC ACID, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, 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, HYDROXYCHLOROQUINE SULFATE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, 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, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, RITUXIMAB, RITUXIMAB, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, ALENDRONATE SODIUM, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, 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, ETANERCEPT, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, CORTISONE ACETATE, CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, APREMILAST, USTEKINUMAB, USTEKINUMAB, USTEKINUMAB, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, ETANERCEPT, 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, NAPROXEN, NAPROXEN SODIUM, APREPITANT, APREPITANT, APREPITANT, APREPITANT, APREPITANT, APREPITANT, APREPITANT, APREPITANT, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METHYLPREDNISOLONE SODIUM SUCCINATE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCLYCLINE HYCLATE, PREGABALIN, SARILUMAB, APREMILAST, APREMILAST, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, TOFACITINIB CITRATE, TOFACITINIB CITRATE, TOFACITINIB, TOFACITINIB CITRATE, TOFACITINIB, TOFACITINIB CITRATE, TOFACITINIB, TOFACITINIB CITRATE, GOLIMUMAB, GOLIMUMAB, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, VEDOLIZUMAB, |
||||
| 333 | 26538085 |
US |
67 | 2 |
Pain, Product use in unapproved indication, |
||||
SARILUMAB, BIMEKIZUMAB, CALCIUM, LORATADINE, LORATADINE TABLET, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, ATORVASTATIN CALCIUM, MAGNESIUM, MONTELUKAST SODIUM, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 334 | 26538102 |
US |
72 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 335 | 26538195 |
US |
79 | 2 |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 336 | 26538209 |
US |
43 | 2 |
Psoriasis, Product use in unapproved indication, |
||||
DUPILUMAB, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE, MICONAZOLE, MICONAZOLE NITRATE, CLINDAMYCIN, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, SEMAGLUTIDE, ORAL SEMAGLUTIDE, LITHIUM CARBONATE, BUPROPION, ALPRAZOLAM, GABAPENTIN, DOXYCYCLINE, DOXYCYCLINE HYCLATE, NALTREXONE, OXYCODONE, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, TIRZEPATIDE, IPRATROPIUM BROMIDE, |
||||
| 337 | 26538216 |
CN |
31 | 1 |
Ecchymosis, Pyrexia, Pain, Rash, Pruritus, Product use in unapproved indication, |
||||
EZETIMIBE, |
||||
| 338 | 26538419 |
EU |
51 | 2 |
Aphasia, Unresponsive to stimuli, Mental impairment, Product use in unapproved indication, |
||||
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, |
||||
| 339 | 26538461 |
76 | ||
Adenocarcinoma pancreas, Product use in unapproved indication, |
||||
TENAPANOR HYDROCHLORIDE, EMPAGLIFLOZIN, PANTOPRAZOLE SODIUM, CHLORTHALIDONE, TELMISARTAN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, ATORVASTATIN CALCIUM, PRUCALOPRIDE, |
||||
| 340 | 26538516 |
EU |
29 | 2 |
Loss of consciousness, Alcohol interaction, Alcohol intolerance, Amnesia, Respiratory rate decreased, Heart rate decreased, Nausea, Product use in unapproved indication, |
||||
| 341 | 26538609 |
60 | 1 | |
Neuropathy peripheral, Product use in unapproved indication, Product prescribing issue, |
||||
MOXIFLOXACIN, MOXIFLOXACIN HYDROCHLORIDE, RIFAMPIN, PYRAZINAMIDE, |
||||
| 342 | 26539180 |
CA |
59 | 2 |
Anxiety, Body temperature increased, Concussion, Contusion, Diarrhoea, Dizziness, Dysgeusia, Dyspepsia, Feeling hot, Flushing, Gastrooesophageal reflux disease, Hostility, Hyperhidrosis, Hypoaesthesia, Irritability, Libido increased, Libido increased, Memory impairment, Middle insomnia, Muscle twitching, Nausea, Nightmare, Personality disorder, Poor quality sleep, Post-traumatic neck syndrome, Rib fracture, Sedation, Soft tissue injury, Somnolence, Sternal fracture, Tremor, Weight decreased, Weight increased, Headache, Migraine, Vertigo, Diarrhoea, Hypoaesthesia, Gastrooesophageal reflux disease, Sternal fracture, Weight decreased, Drug ineffective, Product use in unapproved indication, Off label use, Incorrect route of product administration, Incorrect route of product administration, |
||||
CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, 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%, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, MORPHINE, BUPROPION, BUPROPION, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, SUMATRIPTAN, SUMATRIPTAN, ERENUMAB-AOOE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, ARIPIPRAZOLE, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ALLOPURINOL, BACLOFEN, BACLOFEN, BACLOFEN, BACLOFEN, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LITHIUM, LITHIUM BROMATUM, PREGABALIN, NAPROXEN, NAPROXEN SODIUM, NAPROXEN, NAPROXEN SODIUM, NAPROXEN, NAPROXEN SODIUM, PAROXETINE HYDROCHLORIDE, PREDNISONE, TEMAZEPAM, TOPIRAMATE, TOPIRAMATE SPINKLE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, CLONAZEPAM, CYCLOBENZAPRINE, DULOXETINE HYDROCHLORIDE, ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, TOPIRAMATE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, BUPROPION HYDROBROMIDE, SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, |
||||
| 343 | 26539200 |
US |
1 | |
Rhabdomyolysis, Product use in unapproved indication, |
||||
DAPTOMYCIN, |
||||
| 344 | 26539228 |
US |
||
Alopecia, Product use in unapproved indication, |
||||
DROSPIRENONE, |
||||
| 345 | 26539288 |
US |
34 | 2 |
Feeling hot, Pain, Dizziness, Product use in unapproved indication, |
||||
GADOTERATE MEGLUMINE, |
||||
| 346 | 26539376 |
US |
48 | 2 |
Biliary colic, Condition aggravated, Haemorrhage, Product use in unapproved indication, |
||||
SEMAGLUTIDE, |
||||
| 347 | 26539420 |
US |
19 | 1 |
Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 348 | 26539424 |
US |
45 | 2 |
Rash, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 349 | 26539520 |
JP |
86 | 1 |
Loss of consciousness, Product use in unapproved indication, |
||||
BREXPIPRAZOLE, BREXPIPRAZOLE, LEMBOREXANT, LEMBOREXANT, |
||||
| 350 | 26539558 |
US |
58 | 2 |
Diplopia, Dizziness, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 351 | 26539567 |
US |
73 | 2 |
Injection site pruritus, Injection site erythema, Injection site swelling, Dry eye, Paraesthesia, Eye pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 352 | 26539667 |
ET |
78 | 1 |
Cardiac arrest, Local anaesthetic systemic toxicity, Cerebral atrophy, Hemiparesis, Product use in unapproved indication, |
||||
LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, |
||||
| 353 | 26539848 |
US |
54 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 354 | 26539874 |
US |
21 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 355 | 26539942 |
US |
62 | 2 |
Injection site bruising, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 356 | 26539943 |
US |
59 | 2 |
ADAMTS13 activity decreased, Product use in unapproved indication, |
||||
CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, |
||||
| 357 | 26540149 |
US |
32 | |
Condition aggravated, Product use in unapproved indication, |
||||
C1 ESTERASE INHIBITOR RECOMBINANT, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 358 | 26540214 |
US |
2 | |
Product use in unapproved indication, |
||||
VORINOSTAT, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, BORTEZOMIB, MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE, PEGASPARGASE, |
||||
| 359 | 26540810 |
US |
58 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 360 | 26540812 |
US |
58 | 2 |
Urticaria, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 361 | 26540815 |
US |
45 | 2 |
Dermatitis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 362 | 26540817 |
US |
51 | 2 |
Pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 363 | 26540818 |
US |
2 | |
Condition aggravated, Stress, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 364 | 26540820 |
US |
8 | 2 |
Anxiety, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 365 | 26540827 |
US |
68 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Dermatitis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 366 | 26540828 |
US |
15 | 1 |
Hypersensitivity, Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 367 | 26540917 |
US |
30 | 1 |
Dermatitis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 368 | 26540929 |
US |
36 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 369 | 26540942 |
US |
4 | 1 |
Eczema, Erythema, Dry skin, Erythema of eyelid, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 370 | 26540944 |
US |
38 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 371 | 26540948 |
US |
50 | 1 |
Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 372 | 26540951 |
US |
23 | 2 |
Eczema, Dry skin, Incorrect dose administered by product, Condition aggravated, Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 373 | 26540969 |
US |
64 | 1 |
Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 374 | 26541079 |
US |
58 | 2 |
Product use in unapproved indication, |
||||
POSACONAZOLE, POSACONAZOLE DELAYED-RELEASE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, IRBESARTAN, PREDNISONE, IBRUTINIB, |
||||
| 375 | 26541269 |
EU |
61 | 1 |
Oesophagitis, Product use in unapproved indication, |
||||
TELMISARTAN, |
||||
| 376 | 26541280 |
US |
39 | 1 |
Product use in unapproved indication, |
||||
VORICONAZOLE, VORICONAZOLE INJECTION, VORICONAZOLE, VORICONAZOLE INJECTION, TERBINAFINE HYDROCHLORIDE, TERBINAFINE, |
||||
| 377 | 26541549 |
CN |
66 | 1 |
Hepatic failure, Product prescribing issue, Product use in unapproved indication, Mouth ulceration, Drug eruption, Alanine aminotransferase increased, Hypoalbuminaemia, Paronychia, |
||||
RIVAROXABAN, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, LAZERTINIB, FEBUXOSTAT, FEBUXOSTAT TABLETS 40 MG, FEBUXOSTAT TABLETS 80 MG, FEBUXOSTAT, FEBUXOSTAT TABLETS 40 MG, FEBUXOSTAT TABLETS 80 MG, |
||||
| 378 | 26531164 |
US |
2 | |
Product use in unapproved indication, Drug effective for unapproved indication, |
||||
ADAPALENE, ADAPLANE 0.1%, |
||||
| 379 | 26531453 |
US |
86 | 2 |
Product dose omission issue, Product use in unapproved indication, |
||||
RIPRETINIB, RIPRETINIB, |
||||
| 380 | 26531625 |
US |
10 | 2 |
Product use in unapproved indication, Overdose, Therapeutic response unexpected, |
||||
CETIRIZINE HYDROCHLORIDE, |
||||
| 381 | 26531866 |
US |
2 | |
Ageusia, Tongue discomfort, Incorrect route of product administration, Wrong technique in product usage process, Product use in unapproved indication, Expired product administered, |
||||
NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND HYDROCORTISONE, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, HYDROCORTISONE, BACITRACIN, BACITRACIN ZINC, BACITRACIN, BACITRACIN ZINC, |
||||
| 382 | 26532048 |
EU |
76 | 1 |
Hepatitis cholestatic, Product use in unapproved indication, |
||||
MIRTAZAPINE, MOXIFLOXACIN HYDROCHLORIDE, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, |
||||
| 383 | 26532086 |
US |
||
Application site pruritus, Skin mass, Application site pain, Product use in unapproved indication, Application site erythema, |
||||
NICOTINE, NICOTINE POLACRILEX, NICOTINE POLACRILEX MINI, NICOTINE POLARILEX, |
||||
| 384 | 26532237 |
TN |
70 | 2 |
Pancreatitis acute, Product use in unapproved indication, |
||||
COLCHICINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 385 | 26532267 |
US |
64 | 2 |
Cerebrovascular accident, Anxiety, Post-traumatic stress disorder, Depression, Illness, Wheezing, Pruritus, Sinus disorder, Multiple allergies, Colectomy, Product use in unapproved indication, |
||||
DUPILUMAB, DIPHENHYDRAMINE HYDROCHLORIDE, GABAPENTIN, UMECLIDINIUM, CYCLOSPORINE, LEVOTHYROXINE SODIUM, UBROGEPANT, ERGOCALCIFEROL, CETIRIZINE HYDROCHLORIDE, AMLODIPINE, BACLOFEN, CYCLOSPORINE, PENTOSAN POLYSULFATE SODIUM, FAMOTIDINE, GABAPENTIN, HYDROXYZINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 386 | 26532278 |
IN |
61 | 1 |
Seronegative arthritis, Product use in unapproved indication, |
||||
AZACITIDINE, AZACITIDINE FOR, AZACITIDINE, AZACITIDINE FOR, AZACITIDINE, AZACITIDINE FOR, VENETOCLAX, |
||||
| 387 | 26532330 |
PH |
20 | 1 |
Neutropenia, Neutropenic colitis, Septic shock, Product use in unapproved indication, |
||||
DEXAMETHASONE SODIUM PHOSPHATE, RITUXIMAB, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 388 | 26532355 |
AU |
59 | 1 |
Angle closure glaucoma, Product use in unapproved indication, |
||||
PROCHLORPERAZINE EDISYLATE, FENTANYL, OXYCODONE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE, IPRATROPIUM BROMIDE, ALBUTEROL SULFATE, ALBUTEROL, CHLORPROMAZINE, |
||||
| 389 | 26532369 |
EU |
51 | 1 |
Condition aggravated, Dopamine agonist withdrawal syndrome, Drug ineffective for unapproved indication, Restless leg augmentation syndrome, Hot flush, Brain fog, Hyperhidrosis, Memory impairment, Somnolence, Drug withdrawal syndrome, Electric shock sensation, Fatigue, Myalgia, Treatment noncompliance, Product prescribing issue, Product use in unapproved indication, |
||||
MIRTAZAPINE, PRAMIPEXOLE, PRAMIPEXOLE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, GABAPENTIN, GABAPENTIN, PREGABALIN, PREGABALIN, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, ROTIGOTINE, PRAMIPEXOLE, PRAMIPEXOLE, PRAMIPEXOLE, PRAMIPEXOLE, PRAMIPEXOLE, PRAMIPEXOLE, CLONIDINE, BUPRENORPHINE, TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, ALPRAZOLAM, BUPROPION HYDROCHLORIDE, DIPYRIDAMOLE, BACLOFEN, BISOPROLOL FUMARATE, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, |
||||
| 390 | 26532650 |
US |
63 | |
Death, Product use in unapproved indication, |
||||
| 391 | 26532689 |
US |
||
Product use in unapproved indication, |
||||
ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 392 | 26532708 |
US |
||
Anorectal discomfort, Panic reaction, Crying, Product prescribing issue, Product use in unapproved indication, |
||||
RIFAXIMIN, RIFAXIMIN, |
||||
| 393 | 26532724 |
US |
61 | 2 |
Hemiparesis, Urinary incontinence, Blister, Product use in unapproved indication, |
||||
PEMBROLIZUMAB, PEMBROLIZUMAB, |
||||
| 394 | 26532746 |
CN |
62 | 1 |
Platelet count decreased, Product use in unapproved indication, |
||||
PEMBROLIZUMAB, |
||||
| 395 | 26532872 |
US |
||
Pneumonia, Product use in unapproved indication, |
||||
| 396 | 26533103 |
US |
6 | 1 |
Cough, Nasal congestion, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 397 | 26533111 |
US |
60 | 2 |
Dermatitis atopic, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 398 | 26533163 |
US |
48 | 2 |
Rash, Rash erythematous, Injection site reaction, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 399 | 26533167 |
US |
78 | 1 |
Product use in unapproved indication, Extra dose administered, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 400 | 26533173 |
US |
26 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
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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license
last_updated
2026-04-28