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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: OFF LABEL USE

20260101 - 20261231

No. 401 - 500

Next page: 6 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
401
26560156
US
25
Off label use,
RUXOLITINIB,
402
26560165
US
2
Confusional state, Off label use,
SPARSENTAN,
403
26560174
US
Drug ineffective, Off label use, Product physical consistency issue,
RUXOLITINIB, RUXOLITINIB,
404
26560239
US
67 2
Off label use,
INSULIN GLARGINE,
405
26560253
US
68 1
Off label use,
INSULIN GLARGINE,
406
26560292
US
64 2
Off label use,
DUPILUMAB,
407
26560351
US
2
Malaise, Product dose omission issue, Off label use,
DUPILUMAB, DUPILUMAB,
408
26560359
US
13 1
Off label use,
DUPILUMAB,
409
26560361
US
64
Off label use,
INSULIN GLARGINE,
410
26560369
US
40 2
Off label use,
INSULIN GLARGINE,
411
26560385
US
55 1
Off label use,
DUPILUMAB,
412
26560392
US
13 1
Respiratory tract infection, Off label use,
DUPILUMAB,
413
26560412
US
77 2
Off label use,
DUPILUMAB,
414
26560424
US
73
Off label use,
INSULIN GLARGINE,
415
26560518
US
76 2
Arthritis, Back disorder, Peripheral swelling, Arthralgia, Off label use,
ABATACEPT, ABATACEPT,
416
26560534
US
65 2
Drug reaction with eosinophilia and systemic symptoms, Hepatitis chronic active, Off label use, Coagulopathy, Liver injury, Toxicity to various agents, Drug ineffective, Cholestasis, Hepatic necrosis, Cytomegalovirus viraemia,
LEFLUNOMIDE, CHOLESTYRAMINE, HYDROXYCHLOROQUINE, METHYLPREDNISOLONE, CYCLOSPORINE, CYCLOSPORINE, CYCLOSPORINE,
417
26560570
US
86 1
Death, Off label use,
POMALIDOMIDE,
418
26560585
US
2
Meningioma, Off label use,
MEDROXYPROGESTERONE ACETATE,
419
26560588
AU
61 2
Death, Off label use,
ENCORAFENIB, BINIMETINIB,
420
26560600
CN
6 1
Pulmonary toxicity, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, BASILIXIMAB, METHYLPREDNISOLONE,
421
26560619
CH
58 1
Hypotension, Headache, Dizziness, Off label use,
SPARSENTAN,
422
26560624
US
40 2
Off label use,
SPARSENTAN,
423
26560645
CA
38 1
Drug effective for unapproved indication, Cerebral cavernous malformation, Fatigue, Haemorrhage, Hypertension, Neutropenia, Off label use, Sinusitis,
TOCILIZUMAB, BEVACIZUMAB,
424
26560656
CA
Hyperhidrosis, Nausea, Nephrolithiasis, Sedation, Nightmare, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, ALMOTRIPTAN, ALMOTRIPTAN MALATE, ONABOTULINUMTOXINA, BOTULINUM TOXIN TYPE A, CELECOXIB, MEPERIDINE HYDROCHLORIDE, DICLOFENAC, DICLOFENAC SODIUM, OXYCODONE AND ACETAMINOPHEN, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, GABAPENTIN, KETAMINE HYDROCHLORIDE, RIZATRIPTAN BENZOATE, MORPHINE SULFATE, NORTRIPTYLINE HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, OXYCODONE AND ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, OXYCODONE AND ACETAMINOPHEN TABLETS, ATENOLOL AND CHLORTHALIDONE, DULOXETINE HYDROCHLORIDE, DULOXETINE, TOPIRAMATE, TRAMADOL HYDROCHLORIDE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE,
425
26560716
US
45
Treatment failure, Off label use,
426
26560732
CA
2 1
Dermatitis, Drug ineffective for unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, TRAMETINIB, TRAMETINIB,
427
26560734
CA
2 2
Blood creatine phosphokinase increased, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, TRAMETINIB, TRAMETINIB,
428
26560735
CA
4 1
Epistaxis, Rash, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, FUROSEMIDE, FUROSEMIDE, TRAMETINIB, TRAMETINIB,
429
26560739
CH
2
Off label use,
SPARSENTAN,
430
26560746
US
2
Organ failure, Unevaluable event, Emotional distress, Drug ineffective, Gastrointestinal injury, Liver injury, Illness, Off label use,
PANCRELIPASE,
431
26560775
CA
4 1
Eczema, Oedema, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, SPIRONOLACTONE, TRAMETINIB,
432
26560780
CA
6 1
Dermatitis acneiform, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, FUROSEMIDE, SPIRONOLACTONE, TRAMETINIB,
433
26560783
CA
Hyperhidrosis, Nausea, Sedation, Nephrolithiasis, Nightmare, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, ONABOTULINUMTOXINA, BOTULINUM TOXIN TYPE A, CELECOXIB, MEPERIDINE HYDROCHLORIDE, DICLOFENAC, DICLOFENAC SODIUM, OXYCODONE AND ACETAMINOPHEN, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, GABAPENTIN, HYDROMORPHONE HYDROCHLORIDE, RIZATRIPTAN BENZOATE, MORPHINE SULFATE, ONDANSETRON HYDROCHLORIDE, ATENOLOL AND CHLORTHALIDONE, DULOXETINE HYDROCHLORIDE, DULOXETINE, TOPIRAMATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, ALMOTRIPTAN, ALMOTRIPTAN MALATE,
434
26560795
US
67
Off label use,
IPILIMUMAB, NIVOLUMAB,
435
26560798
CA
3 2
Drug eruption, Alopecia, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, TRAMETINIB,
436
26560799
CA
2 2
Blood creatine phosphokinase increased, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, TRAMETINIB,
437
26560801
CA
2 1
Dermatitis, Drug ineffective, Drug ineffective for unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, TRAMETINIB, TRAMETINIB,
438
26560807
CA
4 1
Epistaxis, Rash, Drug ineffective, Product use in unapproved indication, Off label use,
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, FUROSEMIDE, TRAMETINIB,
439
26560830
EU
2
Death, Off label use,
TEPOTINIB HYDROCHLORIDE, OSIMERTINIB, OSIMERTINIB,
440
26560852
US
1
Off label use,
TEMOZOLOMIDE,
441
26560853
US
1
Off label use,
TEMOZOLOMIDE,
442
26560933
US
11 2
Off label use,
SPARSENTAN, SPARSENTAN,
443
26560945
US
1
Disability, Off label use,
SEMAGLUTIDE, ORAL SEMAGLUTIDE, SEMAGLUTIDE, ORAL SEMAGLUTIDE,
444
26560959
US
1
Off label use,
SPARSENTAN,
445
26560972
Autism spectrum disorder, Abnormal behaviour, Mood disorder due to a general medical condition, Depression, Off label use,
LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LACOSAMIDE, LACOSAMIDE, BRIVARACETAM, BRIVARACETAM INJECTION, BRIVARACETAM, BRIVARACETAM INJECTION, CARBAMAZEPINE, OXCARBAZEPINE, TOPIRAMATE, TOPIRAMATE SPINKLE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, PREGABALIN, PERAMPANEL, CANNABIDIOL, ZONISAMIDE, CENOBAMATE, RUFINAMIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, MELATONIN, LISINOPRIL, BISOPROLOL FUMARATE, MAGNESIUM, CALCIUM,
446
26560981
US
1
Off label use,
SPARSENTAN, SPARSENTAN,
447
26560983
US
2
Pulmonary embolism, Oedema peripheral, Off label use,
OSIMERTINIB,
448
26560984
US
2
Loss of consciousness, Vomiting, Feeling of body temperature change, Dysgeusia, Off label use, Nausea,
SEMAGLUTIDE,
449
26560986
58
Abdominal discomfort, Off label use,
RUXOLITINIB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, ACYCLOVIR, ALLOPURINOL, LORATADINE, LORATADINE TABLET, DAPSONE GEL, 5%, DAPSONE, DASPONE, FOLIC ACID, 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, MAGNESIUM, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, OLANZAPINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, LETERMOVIR, TACROLIMUS, ROSUVASTATIN, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, ERGOCALCIFEROL,
450
26561023
US
1
Off label use,
SPARSENTAN,
451
26561032
BR
55 1
Appendix disorder, Pulmonary calcification, Platelet count decreased, Cholecystitis chronic, Gastrointestinal tract adenoma, Colorectal adenoma, Hepatic enzyme increased, Off label use,
CETUXIMAB, CAPECITABINE,
452
26561034
EU
1
Eye operation, Off label use,
CYCLOSPORINE, CYCLOSPORINE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION,
453
26561092
CA
48 2
Blood pressure increased, Hot flush, Off label use,
RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIMENHYDRINATE, METHYLPREDNISOLONE,
454
26561111
EU
17 2
Dyspnoea, Dizziness, Anxiety, Chest discomfort, Off label use,
METHOTREXATE, METHOTREXATE SODIUM,
455
26561117
CA
60 1
Blood pressure diastolic abnormal, Blood pressure diastolic decreased, Blood pressure fluctuation, Blood pressure increased, Blood pressure systolic abnormal, Decreased appetite, Depression, Gastric infection, Heart rate decreased, Heart rate increased, Nausea, Oxygen saturation decreased, Weight decreased, Off label use,
RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, DIPHENHYDRAMINE HYDROCHLORIDE, CLARITHROMYCIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, LINEZOLID, PREGABALIN, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, MIRTAZAPINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,
456
26561126
CA
72 1
Productive cough, Heart rate increased, Infection, Inappropriate schedule of product administration, Off label use,
RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIMENHYDRINATE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, METHYLPREDNISOLONE,
457
26561235
US
2
Peripheral swelling, Off label use,
SPARSENTAN, SPARSENTAN, SPARSENTAN,
458
26561250
CN
61 1
Abdominal distension, Vomiting, Generalised oedema, Discomfort, Gait inability, Off label use,
LORLATINIB, LORLATINIB,
459
26561260
CA
53 2
Heart rate decreased, Hypoacusis, Meningitis, Off label use,
RITUXIMAB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, GABAPENTIN, 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, HUMAN IMMUNOGLOBULIN G, LEVETIRACETAM, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, LEVOTHYROXINE SODIUM, TOPIRAMATE, TOPIRAMATE SPINKLE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,
460
26561297
KR
47 2
Diaphragmatic disorder, Dyspnoea, Off label use, Abdominal pain upper, Abdominal discomfort,
TIRZEPATIDE,
461
26561317
US
2
Breast cancer, Off label use,
TIRZEPATIDE,
462
26561324
GB
55 2
Faecal vomiting, Constipation, Abdominal pain, Weight decreased, Back pain, Cholelithiasis, Gastritis, Off label use,
TIRZEPATIDE, LANSOPRAZOLE, GLYCERIN, GLYCERIN SUPPOSITORIES, LACTULOSE, ACYCLOVIR, CLOPIDOGREL, CLOPIDOGREL BISULFATE, DOCUSATE SODIUM, DOCUSATE SODIUM 100MG, MIRTAZAPINE, ROSUVASTATIN, AMLODIPINE, INDAPAMIDE, DAPAGLIFLOZIN,
463
26561335
BR
42 1
Blood glucose increased, Off label use, Inappropriate schedule of product administration,
INSULIN GLARGINE,
464
26561364
CA
50 2
Pneumonia, Off label use,
GOLIMUMAB, GOLIMUMAB,
465
26561370
US
28 1
Off label use,
SPARSENTAN,
466
26561382
US
2
Off label use,
TEMOZOLOMIDE,
467
26561385
US
2
Product use in unapproved indication, Off label use,
SPARSENTAN,
468
26561392
US
1
Off label use,
TEMOZOLOMIDE,
469
26561397
US
1
Off label use,
TEMOZOLOMIDE,
470
26561401
US
1
Off label use,
TEMOZOLOMIDE,
471
26561405
US
1
Off label use,
TEMOZOLOMIDE,
472
26561406
US
1
Off label use,
TEMOZOLOMIDE,
473
26561407
US
1
Off label use,
TEMOZOLOMIDE,
474
26561409
US
2
Off label use,
TEMOZOLOMIDE,
475
26561410
US
2
Off label use,
TEMOZOLOMIDE,
476
26561411
US
1
Off label use,
TEMOZOLOMIDE,
477
26561413
US
75 1
Death, Off label use,
TEPROTUMUMAB, TEPROTUMUMAB, TEPROTUMUMAB,
478
26561414
US
2
Off label use,
TEMOZOLOMIDE,
479
26561415
US
2
Off label use,
TEMOZOLOMIDE,
480
26561422
US
2
Off label use,
TEMOZOLOMIDE,
481
26561424
US
1
Off label use,
TEMOZOLOMIDE,
482
26561430
US
2
Off label use,
TEMOZOLOMIDE,
483
26561437
US
2
Off label use,
TEMOZOLOMIDE,
484
26561440
US
1
Off label use,
TEMOZOLOMIDE,
485
26561442
US
2
Off label use,
TEMOZOLOMIDE,
486
26561443
US
1
Off label use,
TEMOZOLOMIDE,
487
26561485
US
64 2
Off label use, Drug ineffective, Weight increased,
TIRZEPATIDE, TIRZEPATIDE,
488
26561507
1
Off label use,
NALTREXONE,
489
26561581
US
65 2
Off label use,
NIVOLUMAB, CABOZANTINIB,
490
26561586
JP
65 1
Device related infection, Peripheral artery stenosis, Off label use, Hypocalcaemia, Skin ulcer,
DARBEPOETIN ALFA, TENAPANOR HYDROCHLORIDE, LANTHANUM CARBONATE, CARVEDILOL, CARVEDILOL, CARVEDILOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LINAGLIPTIN, RABEPRAZOLE SODIUM, RABEPRAZOLE, PITAVASTATIN CALCIUM, PITAVASTATIN, EZETIMIBE, FEBUXOSTAT, FEBUXOSTAT TABLETS 40 MG, FEBUXOSTAT TABLETS 80 MG, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, DROXIDOPA, DROXIDOPA, IRON SUCROSE, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, DEXTROMETHORPHAN HYDROBROMIDE, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN,
491
26569778
Off label use,
DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE,
492
26569793
Off label use, Dyskinesia, Overdose,
PRAMIPEXOLE,
493
26550001
52 1
Pleuroparenchymal fibroelastosis, Alveolar proteinosis, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION,
494
26550030
US
60 2
Off label use,
INSULIN GLARGINE,
495
26550031
US
59
Off label use,
ENOXAPARIN SODIUM,
496
26550032
US
73 2
Off label use,
INSULIN GLARGINE,
497
26550039
US
47
Off label use,
INSULIN GLARGINE-YFGN, INSULIN GLARGINE,
498
26550050
CN
48 1
Flushing, Chest discomfort, Palpitations, Off label use, Oxygen saturation decreased,
TOCILIZUMAB, TOCILIZUMAB,
499
26550059
US
56
Off label use,
INSULIN GLARGINE,
500
26550061
US
80
Off label use,
INSULIN GLARGINE AND LIXISENATIDE,

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

2026-04-28

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