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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.

Product use in unapproved indication: Which Medications Cause It? (222,117 Reports Across 2,100 Drugs)

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Product use in unapproved indication has been reported as an adverse event with 2,100 different drugs in the FDA's FAERS database, with 222,117 total reports. 14,694 of these reports resulted in death.The drugs most commonly associated with Product use in unapproved indication are DUPILUMAB, DICLOFENAC, and METHOTREXATE.

222,117
Total Reports
2,100
Drugs Involved
14,694
Deaths
34,052
Hospitalizations
49.6 yrs
Average Patient Age
59.2% / 40.8%
Female / Male

Which Drugs Cause Product use in unapproved indication Most Often?

Drug Reports % of Drug Reports Deaths Hosp. Life-Threat.
DUPILUMAB 33,452 8.8% 317 1,795 26
DICLOFENAC 12,197 14.1% 1,237 1,518 1,387
METHOTREXATE 8,930 3.5% 2,002 2,876 1,727
PREDNISONE 7,625 4.8% 1,907 2,733 1,659
RITUXIMAB 7,519 4.2% 2,156 2,831 1,808
MYCOPHENOLATE MOFETIL 5,910 7.9% 1,185 1,425 701
ACETAMINOPHEN 5,819 4.3% 1,145 1,785 1,328
CYCLOPHOSPHAMIDE 5,750 4.5% 1,245 1,392 447
RISPERIDONE 5,551 7.0% 69 686 83
TACROLIMUS 5,057 5.6% 744 1,272 258
CYCLOSPORINE 5,019 7.4% 846 1,024 248
GABAPENTIN 4,919 6.6% 206 965 210
ARIPIPRAZOLE 4,792 7.2% 138 2,035 250
CETIRIZINE 4,623 9.7% 1,072 1,261 1,268
INFLIXIMAB 4,598 3.3% 1,240 1,968 1,396
ADAPALENE 4,282 2.4% 0 0 0
METHYLPREDNISOLONE 4,115 6.4% 1,482 1,619 933
ACETAMINOPHEN\ASPIRIN\CAFFEINE 3,758 32.1% 1 18 12
IBUPROFEN 3,596 4.1% 143 516 190
ADALIMUMAB 3,547 0.7% 1,125 1,682 1,392

View all 2,100 drugs →

Top 3 Drugs Associated With Product use in unapproved indication

33,452 reports
12,197 reports
8,930 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)