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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: OFF LABEL USE

20260101 - 20261231

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
26555335
US
1
Off label use, Pain,
TOCILIZUMAB,
2
26555445
AR
67 1
Urticaria, Pruritus, Rash, Acne pustular, Dry skin, Epistaxis, Skin fissures, Miliaria, Perioral dermatitis, Sensitive skin, Skin burning sensation, Erythema, Lip dry, Skin disorder, Off label use,
PANITUMUMAB, PANITUMUMAB, PANITUMUMAB, PANITUMUMAB,
3
26555460
US
56 2
Contusion, Off label use, Diarrhoea,
ABEMACICLIB,
4
26555479
35 1
Collagenous gastritis, Off label use,
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, IRON,
5
26555487
US
42 2
Off label use, Asthenia, Headache, Dizziness, Pyrexia, Swelling face, Off label use,
BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A,
6
26555491
US
Product dose omission issue, Off label use,
LENALIDOMIDE,
7
26555497
US
Off label use, Malaise,
LENALIDOMIDE,
8
26555509
US
4 2
Intentional product use issue, Off label use,
IPRATROPIUM BROMIDE, ALBUTEROL SULFATE, ALBUTEROL,
9
26555536
EU
59
Lymphoma, Testicular neoplasm, Richter^s syndrome, Submandibular gland enlargement, Dysphonia, Stress, General physical health deterioration, Pain in extremity, Night sweats, Dyspnoea, Dyspnoea, Asthenia, Off label use,
RITUXIMAB, VENETOCLAX, PIRTOBRUTINIB,
10
26555539
61 1
Serotonin syndrome, Drug interaction, Off label use,
SERTRALINE,
11
26555548
US
55
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
12
26555562
EU
Angioedema, Ocular hypertension, Chronic spontaneous urticaria, Condition aggravated, Urticaria, Osteoporosis, Asthenia, Myalgia, Drug intolerance, Off label use,
OMALIZUMAB, CYCLOSPORINE,
13
26555563
1
Middle insomnia, Terminal insomnia, Enuresis, Off label use,
SERTRALINE HYDROCHLORIDE, CLONIDINE,
14
26555567
US
2
Feeling abnormal, Arthropathy, Therapy interrupted, Off label use,
ETANERCEPT, ETANERCEPT,
15
26555570
ZA
69 2
Off label use, Retinal thickening,
FARICIMAB,
16
26555574
86 1
Dizziness, Off label use,
SERTRALINE HYDROCHLORIDE, DUPILUMAB,
17
26555578
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
18
26555579
US
40
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A,
19
26555581
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
20
26555591
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
21
26555592
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
22
26555593
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
23
26555594
US
Eyelid irritation, Eyelid ptosis, Ocular hyperaemia, Lacrimation increased, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
24
26555611
EU
48 2
Pancytopenia, Off label use,
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE,
25
26555629
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
26
26555630
US
40
Injection site mass, Tenderness, Off label use,
PRABOTULINUM TOXIN TYPE A,
27
26555631
US
Blepharospasm, Off label use,
PRABOTULINUM TOXIN TYPE A,
28
26555632
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A,
29
26555633
US
34
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
30
26555634
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
31
26555636
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
32
26555637
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
33
26555638
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
34
26555639
US
53
Headache, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
35
26555640
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
36
26555641
US
Periorbital swelling, Off label use,
PRABOTULINUM TOXIN TYPE A,
37
26555685
47 2
Ketosis, Off label use, Product dose omission issue,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, LEVOTHYROXINE SODIUM, DULOXETINE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE,
38
26555690
64
Psoriasis, Mental status changes, Depression, Stress, Drug ineffective, Off label use,
BIMEKIZUMAB, BIMEKIZUMAB, UPADACITINIB,
39
26555712
CA
75 1
Dementia, Off label use,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP,
40
26555734
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
41
26555744
US
48 2
Infusion site erythema, Infusion site warmth, Headache, Nausea, Fatigue, Off label use,
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, DIPHENHYDRAMINE HYDROCHLORIDE,
42
26555782
US
60 1
Product dose omission issue, Off label use,
LENALIDOMIDE,
43
26555784
US
66 1
White blood cell count decreased, Off label use,
POMALIDOMIDE,
44
26555788
36 2
Off label use, Maternal exposure during pregnancy,
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE,
45
26555795
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
46
26555798
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
47
26555799
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
48
26555800
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
49
26555812
EU
64 2
Haematotoxicity, Fatigue, Arthralgia, Off label use,
BEVACIZUMAB, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), CARBOPLATIN, TRAZODONE HYDROCHLORIDE, NIRAPARIB,
50
26555818
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
51
26555824
US
Injection site papule, Injection site pruritus, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
52
26555825
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
53
26555843
US
54
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
54
26555857
US
40
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
55
26555858
US
40
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
56
26555860
US
40
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
57
26555887
US
68
Drug ineffective, Off label use, Headache,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
58
26555892
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
59
26555893
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
60
26555894
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
61
26555895
US
Injection site swelling, Off label use,
PRABOTULINUM TOXIN TYPE A,
62
26555896
US
Injection site pain, Off label use,
PRABOTULINUM TOXIN TYPE A,
63
26555897
US
50
Asthenia, Hypoaesthesia, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
64
26555898
US
32
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
65
26555899
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
66
26555905
US
Periorbital oedema, Headache, Head discomfort, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
67
26555914
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
68
26555915
US
25
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
69
26555936
US
45
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
70
26555939
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
71
26555940
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
72
26555941
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
73
26555943
US
34
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
74
26555945
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
75
26555946
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
76
26555950
US
43
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
77
26555951
US
45
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
78
26555952
US
32
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
79
26555980
CA
Nephrolithiasis, Drug ineffective, Hyperhidrosis, Nausea, Off label use, Product use in unapproved indication, Sedation, Nightmare,
DICLOFENAC SODIUM, ESOMEPRAZOLE MAGNESIUM, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, CELECOXIB, MEPERIDINE HYDROCHLORIDE, OXYCODONE AND ACETAMINOPHEN, HYDROMORPHONE HYDROCHLORIDE, RIZATRIPTAN BENZOATE, MORPHINE SULFATE, ONDANSETRON HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, ATENOLOL AND CHLORTHALIDONE, DULOXETINE HYDROCHLORIDE, DULOXETINE, TOPIRAMATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, ALMOTRIPTAN, ALMOTRIPTAN MALATE, ONABOTULINUMTOXINA, BOTULINUM TOXIN TYPE A, GABAPENTIN,
80
26555999
CA
56
Hospitalisation, Antiphospholipid syndrome, Weight decreased, Night sweats, Off label use,
INFLIXIMAB-DYYB,
81
26556010
62
Spinal fracture, Injection site pain, Road traffic accident, Off label use, Incorrect dose administered, Product knowledge deficit,
BIMEKIZUMAB,
82
26556033
EU
44 1
Jaundice cholestatic, Liver transplant rejection, Cholangitis acute, Hepatic cirrhosis, Wound evisceration, Impaired healing, Off label use,
BEVACIZUMAB, ATEZOLIZUMAB,
83
26556046
US
2
Urticaria, Dyspnoea, Fatigue, Off label use,
OMALIZUMAB, OMALIZUMAB, FLUOXETINE HYDROCHLORIDE,
84
26556066
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A,
85
26556067
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A,
86
26556069
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
87
26556072
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
88
26556074
AR
66 2
Anal incontinence, Rectal haemorrhage, Hepatitis, Skin burning sensation, Swollen tongue, Mouth swelling, Eating disorder, Pain, Rash, Pruritus, Exfoliative rash, Decreased immune responsiveness, Colostomy bag user, Acne pustular, Ill-defined disorder, Rash macular, Erythema, Blister, Malaise, Discomfort, Skin haemorrhage, Dysarthria, Drug ineffective, Dry skin, Off label use, Drug hypersensitivity, Flatulence, Blood test abnormal, Magnetic resonance imaging abnormal, Therapy interrupted, Musculoskeletal pain,
PANITUMUMAB, PANITUMUMAB, PANITUMUMAB, PANITUMUMAB,
89
26556086
US
59 1
Off label use, Gout, Drug ineffective,
TIRZEPATIDE,
90
26556112
EU
59 2
Subretinal fluid, Detachment of macular retinal pigment epithelium, Retinal haemorrhage, Therapeutic product effect decreased, Condition aggravated, Off label use,
RANIBIZUMAB, BEVACIZUMAB, NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE,
91
26556115
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
92
26556116
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
93
26556117
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A,
94
26556118
US
Drug effect less than expected, Off label use,
PRABOTULINUM TOXIN TYPE A,
95
26556119
US
Muscle twitching, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
96
26556120
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
97
26556122
US
Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
98
26556123
US
Injection site vesicles, Swelling of eyelid, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,
99
26556134
US
17 2
Somnolence, Off label use, Rash, Muscle spasms, Off label use, Seizure,
STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, CLOBAZAM, CLOBAZAM, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ERGOCALCIFEROL, ERGOCALCIFEROL, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), 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, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MELATONIN, MELATONIN, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,,
100
26556137
US
Drug ineffective, Off label use,
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A,

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last_updated

2026-04-28

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