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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 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

View all 260 drugs →

Top 3 Drugs Associated With Product label issue

379 reports
276 reports
177 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)