Product label issue: Which Medications Cause It? (5,533 Reports Across 260 Drugs)
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Product label issue has been reported as an adverse event with 260 different drugs in the FDA's FAERS database, with 5,533 total reports. 99 of these reports resulted in death.The drugs most commonly associated with Product label issue are RIVAROXABAN, ACETAMINOPHEN, and GUSELKUMAB.
5,533
Total Reports
260
Drugs Involved
99
Deaths
364
Hospitalizations
59.8 yrs
Average Patient Age
64.2% / 35.8%
Female / Male
Which Drugs Cause Product label issue Most Often?
| Drug | Reports | % of Drug Reports | Deaths | Hosp. | Life-Threat. |
|---|---|---|---|---|---|
| RIVAROXABAN | 379 | 0.3% | 1 | 39 | 1 |
| ACETAMINOPHEN | 276 | 0.2% | 9 | 11 | 2 |
| GUSELKUMAB | 177 | 0.6% | 0 | 3 | 0 |
| USTEKINUMAB | 164 | 0.2% | 0 | 5 | 1 |
| DIMETHICONE\LOPERAMIDE | 154 | 2.8% | 0 | 0 | 0 |
| CETIRIZINE | 138 | 0.3% | 0 | 0 | 1 |
| IBUPROFEN | 99 | 0.1% | 8 | 12 | 9 |
| GOLIMUMAB | 76 | 0.1% | 0 | 1 | 0 |
| POLYETHYLENE GLYCOL 3350 | 76 | 0.2% | 0 | 0 | 0 |
| FENTANYL | 72 | 0.1% | 2 | 3 | 2 |
| LOPERAMIDE | 72 | 0.4% | 0 | 2 | 1 |
| ALBUTEROL | 69 | 0.1% | 1 | 3 | 0 |
| MINOXIDIL | 62 | 0.1% | 0 | 0 | 0 |
| NAPROXEN | 55 | 0.1% | 9 | 10 | 11 |
| APIXABAN | 50 | 0.0% | 1 | 4 | 1 |
| RISPERIDONE | 50 | 0.1% | 1 | 7 | 1 |
| PREGABALIN | 44 | 0.0% | 1 | 6 | 1 |
| NIRMATRELVIR\RITONAVIR | 42 | 0.1% | 1 | 3 | 1 |
| BUDESONIDE\FORMOTEROL | 38 | 0.1% | 0 | 1 | 0 |
| ESTRADIOL | 37 | 0.1% | 0 | 1 | 0 |