🇺🇸 Ibuprofen (Advil) in United States

1,944 US adverse-event reports

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 1,944

Most-reported reactions

1. Drug Ineffective — 374 reports (19.24%)
2. Pain — 370 reports (19.03%)
3. Anxiety — 183 reports (9.41%)
4. Headache — 168 reports (8.64%)
5. Injury — 164 reports (8.44%)
6. Pulmonary Embolism — 154 reports (7.92%)
7. Nausea — 151 reports (7.77%)
8. Deep Vein Thrombosis — 131 reports (6.74%)
9. Dyspnoea — 129 reports (6.64%)
10. Emotional Distress — 120 reports (6.17%)

Source database →

Frequently asked questions

Is Ibuprofen (Advil) approved in United States?

Ibuprofen (Advil) does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Ibuprofen (Advil) in United States?

Bayer is the originator. The local marketing authorisation holder may differ — check the official source linked above.