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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 effective for unapproved indication: Which Medications Cause It? (26,936 Reports Across 421 Drugs)

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Drug effective for unapproved indication has been reported as an adverse event with 421 different drugs in the FDA's FAERS database, with 26,936 total reports. 437 of these reports resulted in death.The drugs most commonly associated with Drug effective for unapproved indication are DICLOFENAC, ACETAMINOPHEN\ASPIRIN\CAFFEINE, and ACETAMINOPHEN\IBUPROFEN.

26,936
Total Reports
421
Drugs Involved
437
Deaths
998
Hospitalizations
54.9 yrs
Average Patient Age
61.2% / 38.8%
Female / Male

Which Drugs Cause Drug effective for unapproved indication Most Often?

Drug Reports % of Drug Reports Deaths Hosp. Life-Threat.
DICLOFENAC 6,550 7.5% 0 4 0
ACETAMINOPHEN\ASPIRIN\CAFFEINE 3,300 28.2% 0 1 0
ACETAMINOPHEN\IBUPROFEN 1,620 53.9% 0 0 0
IBUPROFEN 1,530 1.8% 0 3 0
RITUXIMAB 1,233 0.7% 109 191 49
DIPHENHYDRAMINE\IBUPROFEN 864 21.8% 0 0 0
TOFACITINIB 669 0.4% 5 38 4
PREDNISONE 657 0.4% 71 98 12
NAPROXEN 499 1.0% 0 4 0
BEVACIZUMAB 461 0.6% 78 28 10
DUPILUMAB 452 0.1% 5 14 0
INFLIXIMAB 399 0.3% 46 51 8
RUXOLITINIB 310 0.5% 7 7 0
FLUTICASONE 306 1.0% 0 0 0
CALCIUM 280 1.8% 1 1 0
LORATADINE 280 1.1% 0 0 0
PREGABALIN 275 0.3% 4 27 1
IBUPROFEN\PHENYLEPHRINE 263 21.1% 0 0 0
GUAIFENESIN 246 3.1% 0 0 0
DEXTROMETHORPHAN HYDROBROMIDE\GUAIFENESIN 242 3.6% 0 0 0

View all 421 drugs →

Top 3 Drugs Associated With Drug effective for unapproved indication

6,550 reports
1,620 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)