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RxISK

Making Medicines Safer for All of Us

Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: OFF LABEL USE

20250101 - 20251231

No. 1 - 100

Next page: 2 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
1
25491688
US
1
Off label use,
ARIPIPRAZOLE LAUROXIL,
2
25491724
US
41 1
COVID-19, Migraine, Off label use,
GALCANEZUMAB-GNLM,
3
25491732
US
2
Off label use,
NALTREXONE, NALTREXONE, ESCITALOPRAM, METRONIDAZOLE, METRONIDAZOLE TOPICAL,
4
25491733
US
101 2
Death, Off label use,
LENALIDOMIDE,
5
25491743
US
66 2
Malignant neoplasm progression, Therapy non-responder, Therapeutic product effect incomplete, Thyroiditis, Off label use,
PEMBROLIZUMAB, PEMBROLIZUMAB, CISPLATIN, CARBOPLATIN, BEVACIZUMAB,
6
25491804
US
2
Off label use,
ONABOTULINUMTOXINA,
7
25491815
EG
5 1
Injection site pain, Off label use, Drug administered in wrong device, Product substitution issue,
SOMATROPIN, SOMATROPIN,
8
25491837
US
53 2
Accidental overdose, Off label use,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
9
25491888
US
Off label use,
APALUTAMIDE,
10
25491903
US
60 2
Rash, Rash pruritic, Off label use,
DUPILUMAB,
11
25491933
CN
69
Anaphylactic shock, Off label use,
SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET,
12
25491960
US
1
Off label use, Product use in unapproved therapeutic environment,
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE,
13
25491971
US
2
Choroidal effusion, Angle closure glaucoma, Off label use,
BUPROPION HYDROCHLORIDE, ACYCLOVIR, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, LEVOTHYROXINE, MELATONIN, OXYCODONE, POSACONAZOLE, POSACONAZOLE DELAYED-RELEASE, AMOXICILLIN AND CLAVULANATE POTASSIUM, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE,
14
25491998
US
73 2
Off label use,
15
25492001
US
2
Off label use, Idiopathic urticaria,
OMALIZUMAB, OMALIZUMAB,
16
25492003
CA
67 1
Off label use,
VALPROIC ACID, EXTENDED PHENYTOIN SODIUM, BISOPROLOL FUMARATE, EZETIMIBE, ROSUVASTATIN, TOPIRAMATE, TOPIRAMATE SPINKLE, RAMIPRIL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
17
25492005
US
Wrong technique in product usage process, Off label use,
GUSELKUMAB, GUSELKUMAB,
18
25492010
ES
42 1
Drug interaction, Off label use,
DOXYCYCLINE, DOXYCYCLINE HYCLATE, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION,
19
25492033
US
2
Off label use,
PRUCALOPRIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE,
20
25492079
US
29 2
Mental status changes, Drug ineffective for unapproved indication, Treatment noncompliance, Off label use,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, PHENOBARBITAL, VALPROIC ACID, VALPROIC ACID, OXCARBAZEPINE, METHYLPREDNISOLONE, PHENYTOIN, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
21
25492118
FR
16 1
Substance abuse, Delusion, Miosis, Bradycardia, Off label use,
CLONAZEPAM, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PREGABALIN, LOXAPINE,
22
25492141
CN
37 1
Dermatitis exfoliative generalised, Toxic epidermal necrolysis, Off label use, Anaphylactic shock, Diarrhoea,
BALOXAVIR MARBOXIL,
23
25492153
US
80 2
Anaemia, Off label use,
LENALIDOMIDE, LENALIDOMIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, GEMFIBROZIL, EMPAGLIFLOZIN, LOSARTAN, MAGNESIUM, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, DENOSUMAB, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,,
24
25492160
US
23 1
Condition aggravated, Disturbance in social behaviour, Agitation, Off label use, Off label use,
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE,
25
25492252
US
Off label use,
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB,
26
25492262
US
21 2
Urticaria, Off label use,
OMALIZUMAB,
27
25492296
US
1
Ear pain, Paraesthesia, Facial pain, Intentional product use issue, Expired product administered, Off label use, Product availability issue,
28
25492306
CN
54 2
Myelosuppression, Off label use,
PERTUZUMAB, TRASTUZUMAB, CARBOPLATIN, DOCETAXEL, DOCETAXEL ANHYDROUS,
29
25492348
US
2
Off label use,
LEUPROLIDE ACETATE,
30
25492378
US
1
Urticaria, Intentional product use issue, Off label use,
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, DEGARELIX, ABIRATERONE ACETATE, PREDNISONE,
31
25492382
US
33 2
Off label use, Therapeutic response unexpected, Product use issue,
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, BICALUTAMIDE, LETROZOLE, LETROZOLE TABLETS,
32
25492400
CA
47 2
Obstruction, Diarrhoea, Stoma complication, Abnormal faeces, Gastrointestinal stoma output abnormal, Fatigue, Asthenia, Weight decreased, Frequent bowel movements, Off label use, Gastrointestinal stoma output increased, Pyrexia, Sensitive skin, Abdominal pain lower, Vomiting, Abdominal pain upper, Abdominal pain,
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, OCTREOTIDE ACETATE, OCTREOTIDE, RISANKIZUMAB-RZAA, ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM, ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM, ACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUS, ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM, ALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENS, AVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUM, ADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWER, BELLADONNA, BLATTA ORIENTALIS, COCCUS CACTI, CORALLIUM RUBRUM, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, HEDERA HELIX, HYDRASTIS CANADENSIS, IPECACUANHA, KALI NITRICUM, LAC VACCINUM, LOBELIA INFLATA, PASSIFLORA INCARNATA, PERTUSSINUM, SAMBUCUS NIGRA, THYMUS SERPYLLUM, VALERIANA OFFICINALIS, BALSAMUM PERUVIANUM, BORAX, BRYONIA, CALCAREA ACETICA, COCCUS CACTI, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPHORBIUM OFFICINARUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, KALI BICHROMICUM, LUFFA OPERCULATA, MERCURIUS CYANATUS, MERCURIUS DULCIS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, PANCREATINUM, SAMBUCUS NIGRA, SANGUINARINUM NITRICUM, SAPONARIA OFFICINALIS, ALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CHERRY PLUM, CLEMATIS VITALBA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, EUROPEAN OLIVE, FERRUM PHOSPHORICUM, GENTIANA LUTEA, IMPATIENS GLANDULIFERA, INFLUENZA A VIRUS, LACHESIS MUTUS, LUFFA OPERCULATA, ORNITHOGALUM UMBELLATUM, PHOSPHORUS, ROCKROSE, SARCOLACTICUM ACIDUM, VERATRUM ALBUM, YELLOW JASMINE, ARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUM, ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS, ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, LANSOPRAZOLE, DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, LEVOTHYROXINE, CALCIUM CARBONATE, CALCIUM, ERGOCALCIFEROL, VEDOLIZUMAB,
33
25492403
US
44 1
Anticholinergic syndrome, Off label use, Product delivery mechanism issue, Incorrect dose administered,
ATROPINE SULFATE, ATROPINE, BACLOFEN, DANTROLENE, GABAPENTIN, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE,
34
25492412
US
2
Off label use, Pain,
THYROID, PORCINE,
35
25492414
CA
80 1
Appendicitis, Aortic stenosis, Ascites, Aspiration, Bronchiectasis, Bronchopulmonary aspergillosis allergic, Cardiogenic shock, Congenital hiatus hernia, Diabetes mellitus, End stage renal disease, Hypoxia, Lower respiratory tract infection, Malignant melanoma stage 0, Multiple organ dysfunction syndrome, Myasthenia gravis, Pulmonary embolism, Pulmonary fibrosis, Sepsis, Thrombosis, Ventricular fibrillation, Off label use, Incorrect route of product administration, Intentional product misuse, Product dose omission issue, Product use in unapproved indication,
INSULIN ASPART, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, ALLOPURINOL, AMIODARONE HYDROCHLORIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, HYDROCORTISONE ACETATE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, RAMIPRIL, RAMIPRIL, WARFARIN SODIUM, WARFARIN, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, SODIUM FERRIC GLUCONATE COMPLEX,
36
25492434
US
2
Drug ineffective, Off label use, Arthralgia,
OMALIZUMAB, OMALIZUMAB,
37
25492437
CA
80 2
Dermatitis exfoliative generalised, Therapy non-responder, Off label use,
DUPILUMAB, PREDNISOLONE ACETATE, PREDNISOLONE ACETATE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, AMLODIPINE BESYLATE, LANSOPRAZOLE, MONTELUKAST SODIUM, MONTELUKAST, METHOTREXATE, METHOTREXATE SODIUM, CALCIUM GLUCONATE, MAGNESIUM CITRATE, MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON, LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON,
38
25492464
US
2
Off label use,
NIRAPARIB,
39
25492465
GB
Death, Off label use,
ADALIMUMAB-AATY,
40
25492504
CA
42 1
Colitis ulcerative, Therapy partial responder, Off label use,
VEDOLIZUMAB, VEDOLIZUMAB, PREDNISONE, MESALAMINE,
41
25492508
US
54
Off label use, Injection site reaction,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
42
25492518
US
63 2
Malignant neoplasm progression, Off label use, Drug ineffective,
ABEMACICLIB,
43
25492542
CA
41 2
Alopecia, Myelosuppression, Hepatotoxicity, Toxicity to various agents, Toxicity to various agents, Off label use,
METHOTREXATE, METHOTREXATE SODIUM, MERCAPTOPURINE, TRETINOIN, TRETINOIN, TRETINOIN, ARSENIC TRIOXIDE, ARSENIC TRIOXIDE, PREDNISONE,
44
25492550
US
2 1
Cytopenia, Off label use, Platelet count decreased, Neutrophil count decreased,
REVUMENIB,
45
25492557
CA
21 1
Haematochezia, Frequent bowel movements, Drug ineffective, Off label use,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, ETRASIMOD, BUDESONIDE, PREDNISONE,
46
25492605
PL
10 1
Mucosal inflammation, Viral haemorrhagic cystitis, BK virus infection, Pyrexia, Off label use,
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE, METHOTREXATE, METHOTREXATE SODIUM, THIOTEPA, THIOTEPA, TREOSULFAN, TREOSULFAN, CYCLOSPORINE,
47
25492627
SK
2
Retinal haemorrhage, Haemorrhage, Off label use,
BEVACIZUMAB, AFLIBERCEPT,
48
25492631
ES
62 2
Respiratory distress, Off label use,
49
25492687
US
64 1
Nephritis, Vision blurred, Off label use,
PREDNISONE, FLUOROURACIL CREAM, 0.5%, FLUOROURACIL, OXALIPLATIN, TRASTUZUMAB,
50
25492745
CA
Fall, Lip injury, Eye contusion, Off label use,
51
25492749
CA
53 2
Crohn^s disease, Therapeutic reaction time decreased, Off label use,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, AZATHIOPRINE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,,
52
25492831
US
1
Off label use, Drug ineffective,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
53
25492858
US
2
Off label use,
SPARSENTAN,
54
25492862
US
76 1
COVID-19, Off label use,
POMALIDOMIDE,
55
25492864
US
17 2
Off label use,
SPARSENTAN,
56
25492900
US
38 2
Abortion induced, Pregnancy with contraceptive device, Drug ineffective, Intentional device use issue, Off label use,
COPPER,
57
25492905
US
32 2
Cervix carcinoma, Reproductive complication associated with device, Infertility female, Device breakage, Foreign body in reproductive tract, Complication of device removal, Emotional distress, Device use issue, Off label use,
COPPER, ACYCLOVIR,
58
25492916
PL
44 1
Cerebrovascular accident, Off label use,
EZETIMIBE, DICLOFENAC, DICLOFENAC SODIUM,
59
25492939
US
10 1
Off label use, Multiple-drug resistance,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LACOSAMIDE, FOSPHENYTOIN, FOSPHENYTOIN SODIUM, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, ALEMTUZUMAB,
60
25492942
US
29 2
Hypotension, Vomiting, Maternal exposure during pregnancy, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, DEXMEDETOMIDINE, PROPOFOL, FENTANYL, ROCURONIUM, ROCURONIUM BROMIDE,
61
25492944
US
10 1
Drug ineffective for unapproved indication, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, OLANZAPINE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, LORAZEPAM, MORPHINE,
62
25492945
US
43 1
Drug level decreased, Off label use, Drug ineffective for unapproved indication, Incorrect route of product administration,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LACOSAMIDE, LACOSAMIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PHENOBARBITAL, CLOBAZAM, VALPROIC ACID, METHYLPREDNISOLONE,
63
25492946
US
73 2
Myoclonus, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, FENTANYL, BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE IN DEXTROSE, BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE IN DEXTROSE, PROPOFOL, EPINEPHRINE, ADRENALINUM, CLONIDINE, ALBUTEROL SULFATE, ALBUTEROL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CARISOPRODOL, GABAPENTIN, LISINOPRIL, OXAZEPAM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIMENHYDRINATE, OXYCODONE, CELECOXIB, DEXAMETHASONE, DEXAMETHASONE 1.5 MG,
64
25492947
US
2
Myelitis, Noninfective encephalitis, Off label use,
NIVOLUMAB,
65
25492950
US
Off label use, Drug ineffective for unapproved indication,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
66
25492965
US
47 2
Blood urea increased, Basophil percentage increased, Prothrombin time prolonged, International normalised ratio increased, Off label use,
SPARSENTAN, PREDNISONE, TACROLIMUS, AMLODIPINE, METOPROLOL TARTRATE, METOPROLOL, LOSARTAN, WARFARIN, NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), PANTOPRAZOLE,
67
25492992
US
72 1
Therapeutic product effect incomplete, Off label use,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LACOSAMIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, ATEZOLIZUMAB,
68
25492993
US
Sedation complication, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PROPOFOL,
69
25493022
US
64 2
Drug ineffective for unapproved indication, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
70
25493026
US
32 1
Agitation, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
71
25493027
CA
68 1
Colitis ulcerative, Mantle cell lymphoma, Diarrhoea, Abdominal discomfort, Off label use,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, PREDNISONE, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE,
72
25493030
US
5 1
Multiple-drug resistance, Off label use,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LACOSAMIDE, LACOSAMIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
73
25493032
US
67 1
Drug ineffective for unapproved indication, Off label use,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LACOSAMIDE, LACOSAMIDE, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE, LORAZEPAM, PROPOFOL, LACTULOSE, RIFAXIMIN, FENTANYL, LEVOCARNITINE, LEVOCARNITINE ORAL,
74
25493049
US
2 1
Drug ineffective for unapproved indication, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
75
25493051
US
33 1
Drug ineffective for unapproved indication, Off label use,
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, OLANZAPINE,
76
25493057
US
1
Off label use, Expired product administered,
MIDAZOLAM, MIDAZOLAM,
77
25493079
CA
1
Deep vein thrombosis, Nephrolithiasis, Off label use,
INFLIXIMAB, RIVAROXABAN,
78
25493091
US
2
Dizziness, Off label use,
SPARSENTAN,
79
25493092
US
47 1
Off label use,
SPARSENTAN, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISONE, COLCHICINE, TACROLIMUS EXTENDED-RELEASE CAPSULES,
80
25493096
US
24 2
Off label use, Wrong technique in product usage process,
SPARSENTAN,
81
25493101
US
50 2
Off label use, Product packaging quantity issue,
NORELGESTROMIN AND ETHINYL ESTRADIOL, NORELGESTROMIN AND ETHINYL ESTRADIOL, NORELGESTROMIN AND ETHINYL ESTRADIOL, NORELGESTROMIN AND ETHINYL ESTRADIOL,
82
25493122
JP
88 1
Epilepsy, Tremor, Blood pressure increased, Somnolence, Off label use,
LACOSAMIDE, LACOSAMIDE, BREXPIPRAZOLE, AZILSARTAN KAMEDOXOMIL, LINAGLIPTIN,
83
25493128
US
2
Off label use,
LINACLOTIDE,
84
25493141
DE
44 2
Drug ineffective for unapproved indication, Off label use, Fatigue,
METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, AZATHIOPRINE, AZATHIOPRINE, AZATHIOPRINE, AZATHIOPRINE, CYCLOSPORINE, CYCLOSPORINE, CYCLOSPORINE, CYCLOSPORINE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE,
85
25493144
US
40 1
Drug ineffective, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, BORTEZOMIB FOR INJECTION, BORTEZOMIB, BORTEZOMIB FOR INJECTION, BORTEZOMIB, BORTEZOMIB FOR INJECTION, BORTEZOMIB, BORTEZOMIB FOR INJECTION, BORTEZOMIB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DOXORUBICIN, DOXORUBICIN, DOXORUBICIN, DOXORUBICIN, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, DASATINIB, DASATINIB, DASATINIB, DASATINIB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, RUXOLITINIB, RUXOLITINIB, RUXOLITINIB, RUXOLITINIB,
86
25493147
FR
11 2
Hallucination, Attention deficit hyperactivity disorder, Speech disorder, Off label use,
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE,
87
25493151
CA
1
Administration site plaque, Drug ineffective for unapproved indication, Off label use,
RIVAROXABAN, RIVAROXABAN,
88
25493157
AU
30 2
Central nervous system lupus, Hyperkalaemia, Lupus nephritis, Heart failure with preserved ejection fraction, Renal impairment, Thrombocytopenia, Body mass index abnormal, Gout, Haematuria, Serositis, Abdominal pain, Maternal exposure during pregnancy, Off label use,
ALLOPURINOL, ALLOPURINOL, AZATHIOPRINE, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, FUROSEMIDE, HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE, PANTOPRAZOLE, PANTOPRAZOLE, PRAZOSIN, PRAZOSIN, PRAZOSIN, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, IRBESARTAN, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, COLCHICINE, COLCHICINE, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, RITUXIMAB, DARBEPOETIN ALFA, DARBEPOETIN ALFA, DARBEPOETIN ALFA, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
89
25493213
US
2
Off label use,
SPARSENTAN,
90
25493259
US
42 2
Uterine cervical laceration, Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Cervix scarring, Emotional disorder, Pain, Abdominal pain, Abnormal uterine bleeding, Procedural pain, Discomfort, Device use issue, Off label use,
COPPER,
91
25493261
US
2
Deformity, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Pain, Device use issue, Off label use,
COPPER,
92
25493264
US
41 2
Reproductive complication associated with device, Device breakage, Foreign body in reproductive tract, Complication of device removal, Anxiety, Intentional device use issue, Off label use,
COPPER,
93
25493275
US
Off label use,
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE,
94
25493296
US
53 2
Off label use, Nausea,
TIRZEPATIDE, TIRZEPATIDE,
95
25493342
BR
56 1
Peritonitis, Sepsis, Gastrointestinal disorder, Hepatic cirrhosis, Renal impairment, Drug eruption, Rash vesicular, Off label use,
MICAFUNGIN SODIUM, MICAFUNGIN SODIUM, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, MEROPENEM, MEROPENEM, POLYMYXIN B SULFATE, POLYMYXIN B, POLYMYXIN B SULFATE, POLYMYXIN B, DAPTOMYCIN, DAPTOMYCIN,
96
25493351
US
Off label use,
NIRAPARIB,
97
25493375
GB
Cognitive disorder, Deep vein thrombosis, Anaemia, Weight decreased, Intensive care unit acquired weakness, Haematuria traumatic, Liver function test abnormal, Fungal infection, Infection, Muscle contracture, Thrombophlebitis, Product use in unapproved indication, Off label use, Intentional product use issue,
ACYCLOVIR, LACOSAMIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, METHYLPREDNISOLONE, METHYLPREDNISOLONE, VALPROATE SODIUM, PHENYTOIN, TOPIRAMATE, TOPIRAMATE SPINKLE, PHENOBARBITAL, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, PROPOFOL, PROPOFOL, CLONAZEPAM, CLOBAZAM, LORAZEPAM, FENTANYL, PERAMPANEL,
98
25493385
MX
2
Hip fracture, Gait inability, Tremor, Pruritus, Bone disorder, Dysstasia, Gait disturbance, Urticaria, Fatigue, Erythema, Constipation, Arthralgia, Off label use,
RIBOCICLIB, RIBOCICLIB, RIBOCICLIB, RIBOCICLIB, LETROZOLE, LETROZOLE TABLETS, ZOLEDRONIC ACID,
99
25493400
GB
71 1
Latent tuberculosis, Tuberculosis, Joint tuberculosis, Fistula, Knee deformity, Off label use,
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE,
100
25493403
GB
1
White blood cell count decreased, Drug ineffective for unapproved indication, Off label use, Gastrointestinal disorder,
METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, AZATHIOPRINE, AZATHIOPRINE, AZATHIOPRINE, AZATHIOPRINE, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, VOCLOSPORIN, VOCLOSPORIN, VOCLOSPORIN, VOCLOSPORIN, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE,

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last_updated

2025-07-29

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