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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.

Off label use: Which Medications Cause It? (762,782 Reports Across 3,309 Drugs)

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Off label use has been reported as an adverse event with 3,309 different drugs in the FDA's FAERS database, with 762,782 total reports. 54,628 of these reports resulted in death.The drugs most commonly associated with Off label use are RITUXIMAB, INFLIXIMAB, and DENOSUMAB.

762,782
Total Reports
3,309
Drugs Involved
54,628
Deaths
141,661
Hospitalizations
52.5 yrs
Average Patient Age
60.2% / 39.8%
Female / Male

Which Drugs Cause Off label use Most Often?

Drug Reports % of Drug Reports Deaths Hosp. Life-Threat.
RITUXIMAB 39,751 22.3% 6,335 11,201 4,207
INFLIXIMAB 34,801 24.8% 2,600 9,509 2,818
DENOSUMAB 34,612 23.2% 299 730 55
METHOTREXATE 24,020 9.5% 3,417 7,881 3,680
VEDOLIZUMAB 21,017 28.5% 637 5,998 256
ETANERCEPT 20,178 5.6% 1,852 4,129 2,209
TOCILIZUMAB 18,256 18.5% 3,347 5,844 2,763
PREDNISONE 17,867 11.3% 3,499 6,978 3,057
LENALIDOMIDE 17,017 4.9% 1,252 3,116 250
ADALIMUMAB 16,417 3.3% 2,187 5,051 2,662
HYDROXYCHLOROQUINE 15,318 23.0% 2,584 5,688 2,773
INFLIXIMAB-DYYB 14,256 55.7% 274 3,718 71
MYCOPHENOLATE MOFETIL 13,474 18.0% 2,365 4,340 1,474
DEXAMETHASONE 13,439 10.7% 2,704 4,927 1,297
CYCLOPHOSPHAMIDE 12,578 9.8% 2,788 3,928 1,159
RUXOLITINIB 12,492 18.3% 1,527 1,769 111
BEVACIZUMAB 12,094 15.5% 3,560 1,814 227
TOFACITINIB 11,736 7.5% 1,767 3,218 2,094
ABATACEPT 10,990 9.5% 1,752 3,770 2,430
USTEKINUMAB 10,990 12.9% 1,395 2,924 1,779

View all 3,309 drugs →

Top 3 Drugs Associated With Off label use

39,751 reports
34,801 reports
34,612 reports

Related Side Effects

Drug ineffective (1,049,718) Death (660,423) Fatigue (599,248) Nausea (562,301) Diarrhoea (491,550) Pain (471,975) Headache (460,069) Dyspnoea (409,496) Dizziness (352,922) Malaise (334,268)