Drug:
Reaction: OFF LABEL USE
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26940075 |
US |
65 | 1 |
Off label use, Tendonitis, |
||||
TIRZEPATIDE, |
||||
| 2 | 26940087 |
US |
2 | |
Off label use, |
||||
DUPILUMAB, |
||||
| 3 | 26940110 |
US |
||
Off label use, |
||||
GOLIMUMAB, |
||||
| 4 | 26940136 |
CN |
||
Haemorrhage, Off label use, |
||||
VENETOCLAX, VENETOCLAX, VENETOCLAX, |
||||
| 5 | 26940154 |
CN |
||
Haemorrhage, Off label use, |
||||
VENETOCLAX, VENETOCLAX, |
||||
| 6 | 26940157 |
CN |
||
Haemorrhage, Off label use, |
||||
VENETOCLAX, VENETOCLAX, VENETOCLAX, |
||||
| 7 | 26940186 |
CN |
||
Haemorrhage, Off label use, |
||||
VENETOCLAX, VENETOCLAX, VENETOCLAX, |
||||
| 8 | 26940207 |
AU |
49 | 2 |
Chronic cutaneous lupus erythematosus, Off label use, |
||||
INFLIXIMAB, |
||||
| 9 | 26940214 |
EU |
1 | |
Hospitalisation, Intentional product use issue, Adverse drug reaction, Skin toxicity, Off label use, |
||||
AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, AMIVANTAMAB-VMJW, |
||||
| 10 | 26940222 |
AR |
68 | 1 |
Decreased immune responsiveness, Protein total decreased, Off label use, |
||||
CETUXIMAB, |
||||
| 11 | 26940239 |
US |
1 | |
Off label use, |
||||
DUPILUMAB, |
||||
| 12 | 26940253 |
US |
8 | 1 |
Off label use, Drug ineffective, |
||||
DUPILUMAB, |
||||
| 13 | 26940268 |
CA |
2 | |
Colitis ulcerative, Off label use, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, |
||||
| 14 | 26940271 |
US |
47 | |
Impaired gastric emptying, Off label use, Emotional distress, |
||||
ORAL SEMAGLUTIDE, |
||||
| 15 | 26940308 |
US |
72 | 1 |
Taste disorder, Off label use, |
||||
ISAVUCONAZONIUM SULFATE, |
||||
| 16 | 26940315 |
US |
2 | |
Vertebroplasty, Memory impairment, Weight decreased, Bone pain, Pain in extremity, Abdominal distension, Fatigue, Off label use, Product administered at inappropriate site, |
||||
ABALOPARATIDE, |
||||
| 17 | 26940327 |
US |
2 | |
Off label use, Vaginal discharge, B-lymphocyte count decreased, Malaise, Tension, |
||||
OCRELIZUMAB, |
||||
| 18 | 26940384 |
EU |
2 | |
Dysstasia, Nausea, Malaise, Dizziness, Off label use, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 19 | 26940400 |
US |
1 | |
Gastrointestinal disorder, Gastrointestinal disorder, Pain, Joint swelling, Off label use, |
||||
TOCILIZUMAB, ABATACEPT, |
||||
| 20 | 26940407 |
EU |
61 | 1 |
Metastases to peritoneum, Off label use, |
||||
BEVACIZUMAB, ATEZOLIZUMAB, |
||||
| 21 | 26940489 |
US |
2 | |
Irritable bowel syndrome, Diarrhoea, Nausea, Headache, Off label use, |
||||
ABALOPARATIDE, NINTEDANIB, NINTEDANIB, |
||||
| 22 | 26940492 |
US |
20 | 2 |
Off label use, |
||||
DUPILUMAB, |
||||
| 23 | 26940560 |
US |
2 | |
Knee operation, Injection site haematoma, Constipation, Injection site bruising, Injection site erythema, Palpitations, Incorrect dose administered, Off label use, Product dose omission issue, Product administration interrupted, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, CELECOXIB, CELECOXIB, STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM, |
||||
| 24 | 26940571 |
US |
2 | |
Joint swelling, Fatigue, Heart rate increased, Abdominal distension, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 25 | 26940587 |
US |
2 | |
Migraine, Gastrooesophageal reflux disease, Brain fog, Palpitations, Pain, Headache, Lethargy, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 26 | 26940607 |
US |
11 | 2 |
Off label use, Product use complaint, |
||||
CARIPRAZINE, |
||||
| 27 | 26940625 |
US |
3 | 2 |
Drug specific antibody present, Haemarthrosis, Haemarthrosis, Off label use, |
||||
EMICIZUMAB, |
||||
| 28 | 26940693 |
US |
26 | 2 |
Weight increased, Peripheral swelling, Off label use, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 29 | 26940702 |
CA |
58 | 1 |
Intestinal obstruction, Uveitis, Abdominal adhesions, Condition aggravated, Influenza, Off label use, |
||||
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, PREDNISONE, |
||||
| 30 | 26940708 |
US |
2 | |
Adverse drug reaction, Dizziness, Fear of injection, Off label use, |
||||
ABALOPARATIDE, |
||||
| 31 | 26940733 |
63 | 2 | |
Systemic lupus erythematosus, Off label use, |
||||
NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, PANTOPRAZOLE, ROSUVASTATIN, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE INJECTION, ENALAPRIL, AMLODIPINE, SPIRONOLACTONE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, FLUCONAZOLE, FLUCONAZOLE, FLUCONAZOLE, |
||||
| 32 | 26940742 |
55 | 1 | |
Diabetic ketoacidosis, Neutropenia, Anaemia, Cytomegalovirus colitis, Drug ineffective, Off label use, |
||||
PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR, |
||||
| 33 | 26940753 |
CA |
39 | 2 |
Condition aggravated, Off label use, |
||||
INFLIXIMAB, |
||||
| 34 | 26940756 |
US |
3 | 2 |
Haemarthrosis, Off label use, |
||||
EMICIZUMAB, |
||||
| 35 | 26940781 |
CA |
80 | 1 |
Appendicitis, Appendicolith, Ascites, Cardiogenic shock, General physical health deterioration, Hyponatraemia, Multiple organ dysfunction syndrome, Sepsis, Stress, Ventricular fibrillation, Off label use, |
||||
DARBEPOETIN ALFA, DARBEPOETIN ALFA, DARBEPOETIN ALFA, DARBEPOETIN ALFA, DARBEPOETIN ALFA, DARBEPOETIN ALFA, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, CEFTRIAXONE SODIUM, GABAPENTIN, GABAPENTIN, DOBUTAMINE, DOBUTAMINE, DOBUTAMINE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, INSULIN ASPART, INSULIN ASPART, INSULIN ASPART, INSULIN ASPART, INSULIN ASPART, LANTHANUM CARBONATE, LANTHANUM CARBONATE, LANTHANUM CARBONATE, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 400, INSTALAX POLYETHYLENE GLYCOL 3350, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, MELATONIN, MELATONIN, PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE, SIMVASTATIN, SIMVASTATIN, DEXTROSE MONOHYDRATE, DEXTROSE, DEXTROSE MONOHYDRATE, DEXTROSE, DEXTROSE MONOHYDRATE, DEXTROSE, DEXTROSE MONOHYDRATE, DEXTROSE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, OSELTAMIVIR PHOSPHATE, OSELTAMIVIR ACID, OSELTAMIVIR, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE, PHYTONADIONE, ALBUTEROL SULFATE, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 400, INSTALAX POLYETHYLENE GLYCOL 3350, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, DALTEPARIN SODIUM, DALTEPARIN SODIUM, DALTEPARIN SODIUM, DALTEPARIN SODIUM, DALTEPARIN SODIUM, PHYTONADIONE, SODIUM FERRIC GLUCONATE COMPLEX, SODIUM FERRIC GLUCONATE COMPLEX, HEPARIN SODIUM AND DEXTROSE, HEPARIN SODIUM AND DEXTROSE, VASOPRESSIN, VASOPRESSIN, INSULIN DEGLUDEC, INSULIN DEGLUDEC, DEXTROSE MONOHYDRATE, DEXTROSE, WARFARIN, WARFARIN, WARFARIN, WARFARIN, ASCORBIC ACID, ASCORBIC ACID, ASCORBIC ACID, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE, SIMVASTATIN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, |
||||
| 36 | 26940859 |
US |
2 | |
Asthma, Hypercalcaemia, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 37 | 26940885 |
CA |
59 | 1 |
Condition aggravated, Pruritus, Drug level below therapeutic, Therapeutic product effect incomplete, Off label use, |
||||
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, AZATHIOPRINE, PREDNISONE, |
||||
| 38 | 26940889 |
CN |
33 | 1 |
Neutrophil count decreased, Chest discomfort, Asthenia, Nausea, Vomiting, White blood cell count decreased, Haemoglobin decreased, Decreased appetite, Off label use, |
||||
GEMCITABINE HYDROCHLORIDE, PEGASPARGASE, OXALIPLATIN, |
||||
| 39 | 26940918 |
AU |
||
Mental impairment, Off label use, Product packaging quantity issue, Multiple use of single-use product, Product communication issue, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 40 | 26940932 |
US |
2 | |
Myalgia, Sciatica, Fatigue, Pain, Off label use, |
||||
ABALOPARATIDE, |
||||
| 41 | 26940957 |
US |
37 | 2 |
Neutropenia, Pyelonephritis, Vaginal infection, Dermatitis, Off label use, Therapy partial responder, |
||||
RITUXIMAB, RITUXIMAB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, HYDROXYCHLOROQUINE, |
||||
| 42 | 26940969 |
CN |
74 | 2 |
Myelosuppression, Off label use, |
||||
ZANUBRUTINIB, ZANUBRUTINIB, ZANUBRUTINIB, ZANUBRUTINIB, RITUXIMAB, RITUXIMAB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE, |
||||
| 43 | 26941060 |
US |
2 | |
Drug intolerance, Gait disturbance, Dyspnoea, Pain in extremity, Arthralgia, Fatigue, Bone pain, Headache, Product use issue, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 44 | 26941079 |
US |
||
Off label use, |
||||
ONABOTULINUMTOXINA, |
||||
| 45 | 26941081 |
CA |
59 | 1 |
Renal failure, Pericarditis, Off label use, Diarrhoea, Incontinence, |
||||
INFLIXIMAB, |
||||
| 46 | 26941130 |
US |
69 | 2 |
Feeling jittery, Fungal skin infection, Dyspnoea, Heart rate increased, Fatigue, Blood calcium increased, Palpitations, Off label use, Drug dose omission by device, Liquid product physical issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 47 | 26941131 |
US |
66 | 2 |
Serum procollagen type I N-terminal propeptide decreased, Fatigue, Insomnia, Off label use, |
||||
ABALOPARATIDE, |
||||
| 48 | 26941140 |
US |
2 | |
Injection site pain, Injection site bruising, Nausea, Vomiting, Weight decreased, Product dose omission in error, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 49 | 26941152 |
41 | 1 | |
Rash, White blood cell count increased, Eosinophil count increased, Hepatic enzyme increased, Dermatitis, Off label use, |
||||
CEFOXITIN, CEFOXITIN SODIUM, OMADACYCLINE, LINEZOLID, |
||||
| 50 | 26941202 |
US |
10 | 1 |
Pneumonia, Platelet count decreased, Pruritus, Off label use, |
||||
GIVINOSTAT, GIVINOSTAT, VAMOROLONE, VAMOROLONE, VAMOROLONE, CLONIDINE, GUANFACINE, GUANFACINE HYDROCHLORIDE, GAUNFACINE, LISINOPRIL, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, MELATONIN, ERGOCALCIFEROL, |
||||
| 51 | 26941225 |
US |
||
Off label use, Mania, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 52 | 26941253 |
US |
77 | 2 |
Retinal detachment, Fatigue, Off label use, Decreased appetite, Taste disorder, Alopecia, Eye swelling, Diplopia, Visual impairment, Lacrimation increased, Unevaluable event, |
||||
TEPROTUMUMAB, TEPROTUMUMAB, |
||||
| 53 | 26941291 |
US |
83 | 1 |
Off label use, |
||||
DUPILUMAB, |
||||
| 54 | 26941320 |
US |
1 | |
Off label use, |
||||
ALGLUCOSIDASE ALFA, |
||||
| 55 | 26941330 |
RU |
2 | |
Device defective, Off label use, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 56 | 26941367 |
EU |
65 | 2 |
Death, Drug effective for unapproved indication, Unintentional use for unapproved indication, Off label use, Therapy change, |
||||
EFGARTIGIMOD ALFA, EFGARTIGIMOD ALFA, EFGARTIGIMOD ALFA, EFGARTIGIMOD ALFA, |
||||
| 57 | 26941413 |
US |
69 | |
Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 58 | 26941446 |
68 | ||
Ileus, Intestinal obstruction, Off label use, Emotional distress, |
||||
ORAL SEMAGLUTIDE, |
||||
| 59 | 26941462 |
US |
22 | 2 |
Lupus nephritis, Drug effective for unapproved indication, Off label use, |
||||
RITUXIMAB, RITUXIMAB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, HYDROXYCHLOROQUINE, VOCLOSPORIN, PREDNISONE, |
||||
| 60 | 26941551 |
2 | ||
Therapy non-responder, Off label use, |
||||
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, AMIKACIN, PIPERACILLIN SODIUM,TAZOBACTAM SODIUM, FLUCONAZOLE, PHENOBARBITAL, PHENOBARBITAL, PHENOBARBITAL, CEFTRIAXONE, CEFTRIAXONE SODIUM, CEFTRIAXONE, CEFTRIAXONE SODIUM, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, CLOBAZAM, ERYTHROPOIETIN, ERYTHROPOIETIN, VALPROIC ACID, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, |
||||
| 61 | 26941709 |
US |
61 | 1 |
Off label use, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 62 | 26941723 |
JP |
69 | 1 |
Altered state of consciousness, Somnolence, Dizziness, Off label use, |
||||
DIFELIKEFALIN, EPINASTINE HYDROCHLORIDE, |
||||
| 63 | 26941752 |
US |
79 | 2 |
Chest pain, Injection site erythema, Heart rate increased, Palpitations, Headache, Fatigue, Product administered at inappropriate site, Off label use, Cardiac disorder, Cardiac flutter, Blood calcium increased, |
||||
ABALOPARATIDE, ABALOPARATIDE, AMIODARONE HYDROCHLORIDE, RIVAROXABAN, |
||||
| 64 | 26941762 |
US |
2 | |
Intentional product use issue, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 65 | 26941855 |
US |
1 | |
Off label use, Product temperature excursion issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 66 | 26941872 |
CA |
53 | |
Cardiac murmur, Colitis ulcerative, Impaired quality of life, Pneumonia, Condition aggravated, Frequent bowel movements, Adverse drug reaction, Migraine, Blood cholesterol increased, Bronchiectasis, Hypopnoea, Pain in extremity, Rhinitis, Lymphocyte count decreased, Eczema, Parosmia, Steroid dependence, Abdominal discomfort, Gingival pain, Pulmonary embolism, Catarrh, COVID-19, Vertigo, Impaired work ability, Arthritis, Swollen tongue, Tubulointerstitial nephritis, Palpitations, Dysgeusia, Cerebrovascular accident, Nightmare, Pain, Deep vein thrombosis, Stress, Neutrophil count increased, Monocyte count decreased, C-reactive protein increased, Haemoglobin decreased, Platelet count increased, Haematocrit decreased, Haematochezia, Uterine leiomyoma, Gamma-glutamyltransferase increased, Red cell distribution width increased, Mean cell haemoglobin concentration decreased, Red blood cell count decreased, Mean platelet volume decreased, Depression, Systemic lupus erythematosus, Abdominal lymphadenopathy, Confusional state, Headache, Tinnitus, Somnolence, Rash, Hypersensitivity, Rectal haemorrhage, Pyrexia, Weight decreased, Burns second degree, Alcohol poisoning, Inappropriate schedule of product administration, Product use in unapproved indication, Off label use, Drug ineffective, Accidental overdose, Fatigue, |
||||
ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, 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%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, OXYCODONE, OXYCODONE, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, PREDNISONE, PREDNISONE, PREDNISONE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ESOMEPRAZOLE MAGNESIUM, FUROSEMIDE, SULFASALAZINE, SULFASALAZINE, DESOXIMETASONE, DESOXIMETASONE, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ERGOCALCIFEROL, MESALAMINE, CALCIUM CARBONATE, ANTACID, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, ACETAMINOPHEN AND DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN AND PHENYLEPRINE HCL, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, EPINEPHRINE HYDROCHLORIDE, CANDESARTAN CILEXETIL, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, 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, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, INFLIXIMAB-DYYB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, VEDOLIZUMAB, VEDOLIZUMAB, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, MESALAMINE, MESALAMINE, RAMIPRIL, PRAVASTATIN SODIUM, MESALAMINE, MESALAMINE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, INFLIXIMAB-DYYB, ERGOCALCIFEROL, FESOTERODINE FUMARATE, |
||||
| 67 | 26941902 |
US |
63 | 2 |
Nausea, Dizziness, Off label use, |
||||
BREMELANOTIDE, RANOLAZINE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, SPIRONOLACTONE, MAGNESIUM, |
||||
| 68 | 26941927 |
US |
2 | |
Blood pressure decreased, Neck pain, Tremor, Dry mouth, Glossodynia, Dyspepsia, Orthostatic hypotension, Heart rate increased, Pain in extremity, Nausea, Headache, Abdominal distension, Dizziness, Bone pain, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 69 | 26941947 |
BR |
70 | 2 |
Asphyxia, Renal failure, Product use issue, Dengue fever, Osteoporosis, Device malfunction, Off label use, |
||||
BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, BECLOMETHASONE DIPROPIONATE/FORMOTEROL FUMARATE/GLYCOPYRROLATE, CALCIUM, AMLODIPINE BESYLATE, |
||||
| 70 | 26941969 |
JP |
53 | 2 |
Physical deconditioning, Dehydration, Renal impairment, Feeding disorder, Product dose omission issue, Off label use, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 71 | 26941972 |
CA |
74 | |
Tooth extraction, Malignant melanoma, Arthralgia, Off label use, Inappropriate schedule of product administration, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 72 | 26941992 |
JP |
66 | 1 |
Encephalitis autoimmune, Hyponatraemia, Off label use, |
||||
BEVACIZUMAB, ATEZOLIZUMAB, |
||||
| 73 | 26942002 |
IN |
69 | 1 |
Off label use, Lower respiratory tract infection, Dyspnoea, |
||||
FARICIMAB, FARICIMAB, |
||||
| 74 | 26942008 |
EU |
9 | 1 |
Necrosis, Disease progression, Off label use, |
||||
MELPHALAN HYDROCHLORIDE, MELPHALAN, CARBOPLATIN, IFOSFAMIDE, IFOSFAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DACTINOMYCIN, |
||||
| 75 | 26942010 |
US |
78 | 2 |
Adverse event, Off label use, |
||||
POMALIDOMIDE, |
||||
| 76 | 26942050 |
RU |
17 | 2 |
Hyperthermia, Drug ineffective, Off label use, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE INJECTION, GLATIRAMER, OFATUMUMAB, |
||||
| 77 | 26942131 |
US |
51 | 1 |
Off label use, |
||||
INSULIN GLARGINE, |
||||
| 78 | 26942159 |
US |
51 | 1 |
Off label use, |
||||
DUPILUMAB, |
||||
| 79 | 26942186 |
CA |
20 | |
Rectal haemorrhage, Condition aggravated, Frequent bowel movements, Weight decreased, Weight increased, Off label use, Product dose omission issue, Inappropriate schedule of product administration, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 80 | 26942198 |
57 | 2 | |
Off label use, |
||||
REVUMENIB, |
||||
| 81 | 26942200 |
CA |
39 | 1 |
Condition aggravated, Intentional product use issue, Off label use, Therapeutic response shortened, |
||||
INFLIXIMAB, BUDESONIDE, |
||||
| 82 | 26942202 |
CO |
73 | 1 |
Loss of consciousness, Diarrhoea, Vision blurred, Vomiting, Off label use, |
||||
| 83 | 26942238 |
2 | ||
Off label use, |
||||
REVUMENIB, ACYCLOVIR, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, ALLOPURINOL, SULFAMETHOXAZOLE AND TRIMETHOPRIM, ISAVUCONAZONIUM SULFATE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, DULOXETINE HYDROCHLORIDE, DULOXETINE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE, GRANISETRON, GRANISETRON HYDROCHLORIDE, SENNOSIDES, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDICAINE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, LORAZEPAM, MAGNESIUM HYDROXIDE, METHADONE, METHOCARBAMOL, METHOCARBAMOL TABLETS, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE INJECTION, NALOXONE, PREGABALIN, PROCHLORPERAZINE, SERTRALINE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SUCRALFATE, SUCRALFATE ORAL SUSPENSION, SUCRALFATE ORAL, THIAMINE HYDROCHLORIDE, URSODIOL, URSOSIOL, VENETOCLAX, |
||||
| 84 | 26942269 |
US |
||
Off label use, Drug ineffective, Malaise, |
||||
OSIMERTINIB, |
||||
| 85 | 26942271 |
US |
1 | |
Renal injury, Weight decreased, Abdominal discomfort, Off label use, |
||||
CABOZANTINIB, |
||||
| 86 | 26942278 |
IN |
66 | 2 |
Breast cancer metastatic, Malignant neoplasm progression, Neutropenia, Blood creatinine increased, Positron emission tomogram abnormal, Lymphadenopathy, Breast calcifications, Skin hypertrophy, Off label use, |
||||
RIBOCICLIB, RIBOCICLIB, RIBOCICLIB, RIBOCICLIB, RIBOCICLIB, |
||||
| 87 | 26942281 |
JP |
8 | 2 |
Epilepsy, Prescribed underdose, Off label use, Vomiting, |
||||
FENFLURAMINE, |
||||
| 88 | 26942283 |
CA |
48 | |
Arthritis, Abscess, Fatigue, Swelling face, Weight increased, Infection, Oral candidiasis, Pain, Off label use, Intentional dose omission, Inappropriate schedule of product administration, Suspected off label use, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 89 | 26942316 |
US |
48 | 2 |
Osteonecrosis of jaw, Infection, Off label use, |
||||
ZOLEDRONIC ACID, ZOLEDRONIC ACID, |
||||
| 90 | 26942320 |
US |
1 | |
Off label use, Wrong technique in device usage process, |
||||
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE NASAL, IRBESARTAN, |
||||
| 91 | 26942332 |
EU |
68 | 2 |
Paraesthesia, Eyelid irritation, Abdominal pain upper, Influenza like illness, Overdose, Drug ineffective, Off label use, |
||||
SUMATRIPTAN, SUMATRIPTAN SUCCINATE, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, CITALOPRAM, CITALOPRAM HYDROBROMIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, PREGABALIN, GABAPENTIN, PROPRANOLOL HYDROCHLORIDE, TOPIRAMATE, ZONISAMIDE, |
||||
| 92 | 26942380 |
CN |
47 | 2 |
Myelosuppression, Bone marrow failure, Haemorrhage intracranial, Potentiating drug interaction, Treatment noncompliance, Off label use, |
||||
OLAPARIB, OLAPARIB, TEMOZOLOMIDE, TEMOZOLOMIDE, ATEZOLIZUMAB, ATEZOLIZUMAB, |
||||
| 93 | 26942406 |
US |
1 | |
Death, Off label use, |
||||
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, |
||||
| 94 | 26942413 |
CA |
63 | 1 |
Diabetes mellitus, Drug effective for unapproved indication, Off label use, |
||||
RITUXIMAB, RITUXIMAB, PREDNISONE, PREDNISONE, CYCLOSPORINE, CYCLOSPORINE, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, METHYLPREDNISOLONE, METHYLPREDNISOLONE, |
||||
| 95 | 26942425 |
EU |
53 | 2 |
Hodgkin^s disease, Off label use, |
||||
RITUXIMAB, RITUXIMAB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DOXORUBICIN, DOXORUBICIN, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, PREDNISONE, PREDNISONE, |
||||
| 96 | 26942426 |
US |
2 | 2 |
Off label use, |
||||
DUPILUMAB, |
||||
| 97 | 26942445 |
CA |
2 | |
Peripheral venous disease, Off label use, |
||||
INFLIXIMAB-AXXQ, |
||||
| 98 | 26942479 |
US |
84 | 1 |
Off label use, |
||||
INSULIN GLARGINE, |
||||
| 99 | 26942483 |
EG |
38 | 1 |
Pyrexia, Aspartate aminotransferase increased, Alanine aminotransferase increased, Asthma, Off label use, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, ESOMEPRAZOLE MAGNESIUM, |
||||
| 100 | 26942501 |
CN |
44 | 2 |
Needle issue, Product dose omission issue, Off label use, |
||||
GUSELKUMAB, |
||||
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.
terms
license
last_updated
2026-07-30