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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

Drug ineffective for unapproved indication: Which Medications Cause It? (49,469 Reports Across 1,180 Drugs)

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Drug ineffective for unapproved indication has been reported as an adverse event with 1,180 different drugs in the FDA's FAERS database, with 49,469 total reports. 3,739 of these reports resulted in death.The drugs most commonly associated with Drug ineffective for unapproved indication are GABAPENTIN, METHOTREXATE, and DICLOFENAC.

49,469
Total Reports
1,180
Drugs Involved
3,739
Deaths
7,607
Hospitalizations
51.0 yrs
Average Patient Age
60.7% / 39.3%
Female / Male

Which Drugs Cause Drug ineffective for unapproved indication Most Often?

Drug Reports % of Drug Reports Deaths Hosp. Life-Threat.
GABAPENTIN 5,231 7.0% 26 442 50
METHOTREXATE 2,513 1.0% 257 448 115
DICLOFENAC 2,154 2.5% 36 106 58
RITUXIMAB 1,776 1.0% 389 490 193
LIDOCAINE 1,761 7.8% 10 144 57
METHYLPREDNISOLONE 1,750 2.7% 507 797 407
PREDNISONE 1,598 1.0% 214 424 160
MYCOPHENOLATE MOFETIL 1,596 2.1% 216 438 132
HUMAN IMMUNOGLOBULIN G 1,527 2.2% 601 412 225
DEXAMETHASONE 1,302 1.0% 415 660 254
DUPILUMAB 1,128 0.3% 1 25 1
PREGABALIN 1,122 1.1% 24 197 25
CYCLOPHOSPHAMIDE 1,097 0.9% 334 303 106
CYCLOSPORINE 1,096 1.6% 206 279 108
TACROLIMUS 1,050 1.2% 184 316 80
PREDNISOLONE 962 1.2% 176 343 102
TOPIRAMATE 927 3.2% 53 151 54
ACETAMINOPHEN 880 0.6% 47 175 73
INFLIXIMAB 875 0.6% 140 200 52
TOFACITINIB 872 0.6% 45 93 41

View all 1,180 drugs →

Top 3 Drugs Associated With Drug ineffective for unapproved indication

5,231 reports
2,513 reports
2,154 reports

Related Side Effects

Drug ineffective (1,049,718) Off label use (762,782) Death (660,423) Fatigue (599,248) Nausea (562,301) Diarrhoea (491,550) Pain (471,975) Headache (460,069) Dyspnoea (409,496) Dizziness (352,922)