Drug:
Reaction: OFF LABEL USE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 25138792 |
ES |
62 | 2 |
Condition aggravated, Acute kidney injury, Decreased appetite, Off label use, |
||||
LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE, TACROLIMUS, MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, PREDNISONE, |
||||
| 2 | 25138806 |
US |
55 | 1 |
Haemorrhage, Off label use, |
||||
EMICIZUMAB, DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE, |
||||
| 3 | 25138807 |
US |
2 | |
Injection site pruritus, Off label use, |
||||
TOCILIZUMAB, GLIPIZIDE, EMPAGLIFLOZIN, DRONEDARONE, PREDNISONE, PREGABALIN, |
||||
| 4 | 25138822 |
PT |
48 | |
Off label use, Drug dose omission by device, Oxygen saturation decreased, Illness, Device delivery system issue, |
||||
| 5 | 25138832 |
ES |
2 | |
Angina pectoris, Off label use, |
||||
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, LENALIDOMIDE, CARFILZOMIB, ISATUXIMAB, |
||||
| 6 | 25138883 |
CA |
56 | 2 |
Depressed level of consciousness, Drug intolerance, Drug interaction, Electrocardiogram QT prolonged, Fall, Mental disorder, Nephropathy toxic, Serotonin syndrome, Toxicity to various agents, Contraindicated product administered, Off label use, Hypertension, Drug ineffective, Drug ineffective for unapproved indication, |
||||
ERENUMAB-AOOE, CANDESARTAN, CANDESARTAN, MIRTAZAPINE, MIRTAZAPINE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, OXYCODONE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, GABAPENTIN, GABAPENTIN, INDOMETHACIN, PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, BOTULINUM TOXIN TYPE A, DIVALPROEX SODIUM, |
||||
| 7 | 25138901 |
JP |
3 | |
Small intestine ulcer, Off label use, |
||||
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, |
||||
| 8 | 25138946 |
US |
2 | |
Urticaria, Off label use, |
||||
OMALIZUMAB, OMALIZUMAB, ADALIMUMAB-ADAZ, |
||||
| 9 | 25139001 |
US |
78 | 2 |
Rehabilitation therapy, Mastication disorder, Off label use, Pain in jaw, Tremor, |
||||
DEUTETRABENAZINE, DEUTETRABENAZINE, |
||||
| 10 | 25139008 |
AU |
||
Dilated cardiomyopathy, Torsade de pointes, Gastrointestinal pain, Drug effective for unapproved indication, Off label use, |
||||
BUPRENORPHINE AND NALOXONE, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HCL, |
||||
| 11 | 25139009 |
DE |
2 | |
Mental impairment, Ataxia, Off label use, |
||||
LACOSAMIDE, LACOSAMIDE, |
||||
| 12 | 25139013 |
DE |
50 | 2 |
Epilepsy, Generalised tonic-clonic seizure, Road traffic accident, Fatigue, Off label use, Drug ineffective, |
||||
LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, BRIVARACETAM, BRIVARACETAM, |
||||
| 13 | 25139035 |
US |
77 | |
Cystoid macular oedema, Condition aggravated, Off label use, Drug ineffective for unapproved indication, |
||||
AFLIBERCEPT, AFLIBERCEPT, FARICIMAB, |
||||
| 14 | 25139037 |
US |
1 | |
Off label use, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 15 | 25139041 |
US |
2 | |
Off label use, Feeling abnormal, Malaise, |
||||
THYROID, PORCINE, LEVOTHYROXINE, |
||||
| 16 | 25139056 |
JP |
2 | |
Small intestine ulcer, Off label use, |
||||
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, |
||||
| 17 | 25139121 |
JP |
77 | 1 |
Rash, Off label use, |
||||
HEPARIN SODIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LANSOPRAZOLE, IRBESARTAN, |
||||
| 18 | 25139148 |
JP |
58 | 2 |
Hospitalisation, Off label use, |
||||
FILGRASTIM, |
||||
| 19 | 25139159 |
US |
1 | |
Off label use, No adverse event, |
||||
BEVACIZUMAB, BEVACIZUMAB, FARICIMAB, FARICIMAB, |
||||
| 20 | 25139165 |
CA |
84 | |
Sensation of foreign body, Product contamination physical, Off label use, Device defective, Intentional product misuse, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 21 | 25139202 |
US |
||
No adverse event, Off label use, |
||||
BALOXAVIR MARBOXIL, |
||||
| 22 | 25139206 |
TW |
68 | 2 |
Pulmonary mass, Disease progression, Metastases to lung, Metastases to pleura, Soft tissue neoplasm, Metastases to liver, Off label use, |
||||
ERLOTINIB HYDROCHLORIDE, ATEZOLIZUMAB, BEVACIZUMAB, PACLITAXEL, |
||||
| 23 | 25139267 |
CA |
||
Lip and/or oral cavity cancer, Off label use, |
||||
INFLIXIMAB-DYYB, METHOTREXATE, METHOTREXATE SODIUM, PREDNISONE, |
||||
| 24 | 25139279 |
US |
||
Hepatic enzyme increased, Off label use, |
||||
BEVACIZUMAB-AWWB, |
||||
| 25 | 25139293 |
US |
38 | 2 |
Off label use, Maternal exposure during pregnancy, |
||||
TIRZEPATIDE, |
||||
| 26 | 25139330 |
US |
24 | 1 |
Duplicate therapy error, Off label use, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, DUPILUMAB, |
||||
| 27 | 25139342 |
CN |
39 | 2 |
Hepatic function abnormal, Hyperpyrexia, Nephropathy toxic, Myocardial necrosis marker increased, Oxygen saturation decreased, C-reactive protein increased, White blood cell count increased, Neutrophil count increased, Lymphocyte count decreased, Peripheral coldness, Cyanosis, Nail bed disorder, Sinus tachycardia, Electrocardiogram T wave abnormal, Flushing, Hypotension, Red blood cell count decreased, Platelet count decreased, Oedema, Off label use, |
||||
OXCARBAZEPINE, VALPROATE SODIUM, CLONAZEPAM, |
||||
| 28 | 25139381 |
CA |
||
Breast tumour excision, Drug level decreased, Condition aggravated, Off label use, Intentional product use issue, Off label use, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, LEVOTHYROXINE SODIUM, |
||||
| 29 | 25139442 |
AU |
||
Crohn^s disease, Epstein Barr virus positive mucocutaneous ulcer, Off label use, |
||||
INFLIXIMAB, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 30 | 25139468 |
US |
84 | 1 |
Pancytopenia, Sepsis, Off label use, |
||||
ETOPOSIDE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DOXORUBICIN, RITUXIMAB, PREDNISONE, |
||||
| 31 | 25139470 |
US |
1 | |
Off label use, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 32 | 25139479 |
US |
43 | 2 |
Off label use, Headache, Dry eye, Muscular weakness, Arthralgia, Pain, COVID-19, Diarrhoea, Nausea, Abdominal distension, Flatulence, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, LEVOKETOCONAZOLE, LEVOKETOCONAZOLE, LEVOKETOCONAZOLE, GOLIMUMAB, PREGABALIN, |
||||
| 33 | 25139503 |
US |
70 | 2 |
Off label use, |
||||
LENALIDOMIDE, |
||||
| 34 | 25139521 |
CA |
41 | 1 |
Erectile dysfunction, Painful erection, Spontaneous penile erection, Sleep disorder due to general medical condition, insomnia type, Disturbance in attention, Irritability, Hypersomnia, Psoriasis, Disease recurrence, Fatigue, Off label use, |
||||
BRODALUMAB, BRODALUMAB, |
||||
| 35 | 25139522 |
DE |
52 | 2 |
Plasma cell myeloma, Off label use, |
||||
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, LENALIDOMIDE, CARFILZOMIB, CISPLATIN, DOXORUBICIN, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, ETOPOSIDE, |
||||
| 36 | 25139547 |
CA |
||
Intestinal stenosis, Condition aggravated, Faecal calprotectin increased, Off label use, Off label use, Intentional product use issue, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 37 | 25139577 |
AU |
44 | 2 |
Myocarditis, Drug interaction, Off label use, Treatment failure, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, LURASIDONE HYDROCHLORIDE, AMISULPRIDE, OLANZAPINE, ASENAPINE, ASENAPINE MALEATE, CLOZAPINE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, PALIPERIDONE, |
||||
| 38 | 25139588 |
US |
86 | 2 |
Off label use, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 39 | 25139605 |
US |
70 | 2 |
Appendix disorder, Off label use, |
||||
LENALIDOMIDE, CELECOXIB, SULFAMETHOXAZOLE AND TRIMETHOPRIM, ERGOCALCIFEROL, ACYCLOVIR, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, GABAPENTIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 40 | 25139606 |
US |
2 | |
Off label use, |
||||
ONABOTULINUMTOXINA, |
||||
| 41 | 25139624 |
CA |
2 | |
Pneumonia, Off label use, Cough, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, PREDNISONE, MESALAMINE, LANSOPRAZOLE, ERGOCALCIFEROL, MELATONIN, |
||||
| 42 | 25139691 |
US |
49 | 2 |
Off label use, Weight increased, Chills, Vomiting, Abdominal pain, Eructation, Diarrhoea, Flatulence, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, MONTELUKAST, |
||||
| 43 | 25139707 |
FR |
63 | 2 |
Thrombocytopenia, Off label use, |
||||
LINEZOLID, CEFIDEROCOL SULFATE TOSYLATE, |
||||
| 44 | 25139714 |
TR |
21 | 2 |
Habitual abortion, Maternal exposure during pregnancy, Off label use, |
||||
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE, |
||||
| 45 | 25139735 |
US |
35 | 1 |
Refusal of treatment by patient, Off label use, |
||||
BEVACIZUMAB-AWWB, |
||||
| 46 | 25139747 |
IT |
52 | 1 |
Condition aggravated, Off label use, |
||||
RITUXIMAB, RITUXIMAB, EVEROLIMUS, EVEROLIMUS TABLETS, FOSCARNET SODIUM, FOSCARNET SODIUM, |
||||
| 47 | 25139756 |
IL |
||
Ill-defined disorder, Off label use, |
||||
BEVACIZUMAB, |
||||
| 48 | 25139763 |
US |
66 | 1 |
Atrioventricular block complete, Cardiac failure acute, Pulmonary oedema, Blood creatinine increased, Atrioventricular block second degree, Bundle branch block left, Bundle branch block right, Off label use, |
||||
CARFILZOMIB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, |
||||
| 49 | 25139767 |
US |
2 | |
Product use issue, Ocular discomfort, Off label use, Cytomegalovirus infection, |
||||
MARIBAVIR, MARIBAVIR, |
||||
| 50 | 25139772 |
US |
56 | 2 |
Cardiac failure, Off label use, |
||||
CARFILZOMIB, CARFILZOMIB, VENETOCLAX, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, |
||||
| 51 | 25139779 |
US |
2 | |
Off label use, |
||||
ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, |
||||
| 52 | 25139797 |
JP |
66 | 2 |
Muscular weakness, Muscular weakness, Hypoaesthesia, Rehabilitation therapy, Drug ineffective for unapproved indication, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, |
||||
| 53 | 25139801 |
US |
34 | 2 |
Off label use, Maternal exposure before pregnancy, No adverse event, |
||||
SATRALIZUMAB, |
||||
| 54 | 25139806 |
US |
81 | 2 |
Interstitial lung disease, Limb discomfort, Pain in extremity, Synovial rupture, Chronic obstructive pulmonary disease, Condition aggravated, Off label use, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 55 | 25139838 |
CA |
1 | |
Arthritis infective, Off label use, |
||||
TOCILIZUMAB, CALCIUM, CELECOXIB, PREDNISONE, DENOSUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 56 | 25139840 |
GB |
56 | 1 |
Urine output decreased, Hypoaesthesia, Nocturia, Diarrhoea, Off label use, |
||||
OXALIPLATIN, CAPECITABINE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE, |
||||
| 57 | 25139846 |
US |
||
Glioblastoma, Drug ineffective for unapproved indication, Off label use, |
||||
BEVACIZUMAB, |
||||
| 58 | 25139860 |
SK |
||
Endophthalmitis, Eye inflammation, Off label use, |
||||
BEVACIZUMAB, BEVACIZUMAB, FARICIMAB, FARICIMAB, |
||||
| 59 | 25139887 |
GB |
52 | 1 |
Rectal haemorrhage, Haemorrhoids, Constipation, Off label use, |
||||
PREGABALIN, PREGABALIN, SERTRALINE, |
||||
| 60 | 25139925 |
CN |
86 | 2 |
Haematochezia, Haemoglobin decreased, Off label use, |
||||
CELECOXIB, CELECOXIB, CELECOXIB, CELECOXIB, |
||||
| 61 | 25139946 |
US |
19 | 2 |
Off label use, Therapeutic response unexpected, Prescribed overdose, Peripheral swelling, Oedema peripheral, |
||||
CETIRIZINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, FAMOTIDINE, ALBUTEROL SULFATE, ALBUTEROL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 62 | 25140105 |
ES |
||
Off label use, Intercepted product preparation error, Product reconstitution quality issue, Syringe issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 63 | 25140205 |
US |
2 | |
Condition aggravated, Off label use, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 64 | 25140273 |
US |
||
Off label use, |
||||
ONABOTULINUMTOXINA, |
||||
| 65 | 25140279 |
US |
1 | |
Off label use, |
||||
FLUTICASONE PROPIONATE, |
||||
| 66 | 25140343 |
CA |
1 | |
Death, Palliative care, Off label use, |
||||
LANREOTIDE ACETATE, OCTREOTIDE ACETATE, PERINDOPRIL ERBUMINE, BRINZOLAMIDE, BISOPROLOL FUMARATE, RIVAROXABAN, FUROSEMIDE, CARBOXYMETHYLCELLULOSE SODIUM, |
||||
| 67 | 25140350 |
US |
2 | |
Psoriatic arthropathy, Joint injury, Arthralgia, Ear pruritus, Skin exfoliation, Hepatic steatosis, Blood test abnormal, Therapeutic product effect incomplete, Off label use, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, ROFLUMILAST, |
||||
| 68 | 25140353 |
US |
8 | 1 |
Off label use, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 69 | 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, |
||||
| 70 | 25140403 |
73 | ||
Off label use, |
||||
RUXOLITINIB, CARVEDILOL, CIPROFLOXACIN HYDROCHLORIDE, FAMOTIDINE, |
||||
| 71 | 25140443 |
DE |
70 | 2 |
Gait disturbance, Reactive gastropathy, Microscopic enteritis, Neuralgia, Condition aggravated, Off label use, |
||||
CARBAMAZEPINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, OXCARBAZEPINE, |
||||
| 72 | 25140479 |
PR |
61 | 1 |
Bronchitis, Cough, Asthenia, Nasal congestion, Malaise, Off label use, |
||||
LENALIDOMIDE, |
||||
| 73 | 25140486 |
JP |
1 | 2 |
Drug ineffective, Off label use, |
||||
FOSPHENYTOIN SODIUM, FOSPHENYTOIN, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PHENOBARBITAL, |
||||
| 74 | 25140487 |
IN |
42 | 1 |
Immunodeficiency, Strongyloidiasis, Malabsorption, Hypoalbuminaemia, Iron deficiency anaemia, Off label use, |
||||
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, |
||||
| 75 | 25140494 |
JP |
81 | 1 |
Drug ineffective for unapproved indication, Off label use, |
||||
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, CAPLACIZUMAB, |
||||
| 76 | 25140495 |
JP |
8 | 1 |
Drug clearance decreased, Off label use, |
||||
METHOTREXATE SODIUM, LEVOLEUCOVORIN INJECTION, LEVOLEUCOVORIN CALCIUM, LEVOLEUCOVORIN, |
||||
| 77 | 25140504 |
ES |
67 | 1 |
COVID-19, Off label use, Drug effective for unapproved indication, |
||||
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, PREDNISONE, AZATHIOPRINE, |
||||
| 78 | 25140523 |
GB |
45 | 1 |
Acute psychosis, Off label use, |
||||
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, TESTOSTERONE, TESTOSTERONE,, LEVOTHYROXINE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, INFLIXIMAB, INFLIXIMAB, |
||||
| 79 | 25140558 |
US |
78 | 1 |
Product dose omission issue, Off label use, |
||||
LENALIDOMIDE, |
||||
| 80 | 25140604 |
US |
72 | 2 |
Pneumonia, COVID-19, Gait disturbance, Off label use, |
||||
LEVOKETOCONAZOLE, |
||||
| 81 | 25140627 |
CN |
62 | 1 |
Hepatocellular carcinoma, Off label use, |
||||
SIROLIMUS, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, AMLODIPINE BESYLATE, |
||||
| 82 | 25140629 |
IT |
76 | 2 |
Cholestasis, Hypertransaminasaemia, Off label use, |
||||
TRASTUZUMAB, PACLITAXEL, PERTUZUMAB, |
||||
| 83 | 25140659 |
US |
78 | 2 |
Off label use, Device defective, Device breakage, |
||||
PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, |
||||
| 84 | 25140661 |
US |
75 | 2 |
Off label use, Product adhesion issue, |
||||
ESTRADIOL, FLUOXETINE HYDROCHLORIDE, |
||||
| 85 | 25140710 |
US |
73 | 2 |
Off label use, Device delivery system issue, |
||||
PRAMOXINE HYDROCHLORIDE HYDROCORTISONE ACETATE, |
||||
| 86 | 25140761 |
JP |
||
Pneumonia, Sepsis, Intestinal perforation, Gastrointestinal disorder, Off label use, |
||||
INFLIXIMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 87 | 25140762 |
US |
66 | 1 |
POEMS syndrome, Off label use, |
||||
PREDNISONE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, LENALIDOMIDE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, |
||||
| 88 | 25140795 |
US |
13 | 1 |
Device information output issue, Device mechanical issue, Off label use, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 89 | 25140805 |
KR |
78 | 1 |
Prostate cancer, Off label use, |
||||
| 90 | 25140810 |
GR |
22 | 1 |
Polyomavirus-associated nephropathy, C3 glomerulopathy, Drug effective for unapproved indication, Off label use, |
||||
ECULIZUMAB, ECULIZUMAB, RITUXIMAB, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, |
||||
| 91 | 25140858 |
|||
Neuropathy peripheral, Off label use, |
||||
RUXOLITINIB, |
||||
| 92 | 25140894 |
US |
2 | |
Alopecia, Off label use, |
||||
| 93 | 25140895 |
US |
67 | 1 |
Capillary leak syndrome, Respiratory failure, Neuropathy peripheral, Renal failure, Ascites, Hypotension, Off label use, |
||||
PREDNISONE, PREDNISONE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, |
||||
| 94 | 25140898 |
US |
||
Drug ineffective, Off label use, |
||||
INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, |
||||
| 95 | 25140941 |
IT |
31 | 1 |
Dilated cardiomyopathy, Cardiac failure acute, Left ventricular dysfunction, Drug abuse, Pulmonary oedema, Pneumonia, Hepatic steatosis, Hepatomegaly, Renal failure, Off label use, |
||||
SOMATROPIN, TESTOSTERONE, TESTOSTERONE,, |
||||
| 96 | 25140951 |
41 | ||
Off label use, |
||||
RUXOLITINIB, DUVELISIB, |
||||
| 97 | 25140966 |
|||
Stomatitis, Off label use, |
||||
RUXOLITINIB, |
||||
| 98 | 25140971 |
80 | 1 | |
Off label use, Hereditary ataxia, Condition aggravated, General physical health deterioration, Fall, Gait disturbance, Dysphonia, |
||||
DALFAMPRIDINE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, VALSARTAN, VALSARTAN ORAL, FUROSEMIDE, CARVEDILOL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, |
||||
| 99 | 25140998 |
DE |
1 | |
Autoimmune colitis, Off label use, |
||||
SECUKINUMAB, SECUKINUMAB, IPILIMUMAB, NIVOLUMAB, |
||||
| 100 | 25141050 |
CA |
47 | 2 |
Cardiac failure congestive, Drug hypersensitivity, Nausea, Malaise, Drug ineffective, Diarrhoea, Abdominal discomfort, Abdominal pain upper, Arthralgia, Cough, Rash, Headache, Off label use, Product use issue, Hepatic enzyme increased, Liver disorder, Pain, Cardiac failure, Hypersensitivity, Dyspnoea, Gastrointestinal disorder, Hepatic steatosis, Hypertension, Therapeutic product effect decreased, Contraindicated product administered, |
||||
RABEPRAZOLE SODIUM, RABEPRAZOLE, RANITIDINE, COLCHICINE, PATIROMER, CELECOXIB, CEPHALEXIN, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, LEFLUNOMIDE, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, ENALAPRIL, ETANERCEPT, ALENDRONATE SODIUM, HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, LOSARTAN, METHOTREXATE, METHOTREXATE SODIUM, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, MOXIFLOXACIN HYDROCHLORIDE, ABATACEPT, PENICILLIN G, HYDROXYCHLOROQUINE SULFATE, ISONIAZID, TOFACITINIB, RITUXIMAB, ADALIMUMAB, HYDROXYCHLOROQUINE SULFATE, ALENDRONATE SODIUM, CLARITHROMYCIN, HYDROXYCHLOROQUINE SULFATE, LEFLUNOMIDE, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, IRON SUCROSE, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, PERINDOPRIL ERBUMINE, PREDNISONE, ATENOLOL, LEVOTHYROXINE, |
||||
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Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-04-28