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 |