🇺🇸 Pseudoephedrine/Paracetamol in United States

14 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: 14

Most-reported reactions

1. Colitis Ischaemic — 2 reports (14.29%)
2. Drug Toxicity — 2 reports (14.29%)
3. Renal Failure — 2 reports (14.29%)
4. Renal Tubular Necrosis — 2 reports (14.29%)
5. Abdominal Pain Lower — 1 report (7.14%)
6. Acute Generalised Exanthematous Pustulosis — 1 report (7.14%)
7. Acute Kidney Injury — 1 report (7.14%)
8. Ascites — 1 report (7.14%)
9. Asthenia — 1 report (7.14%)
10. Biliary Dilatation — 1 report (7.14%)

Source database →

Frequently asked questions

Is Pseudoephedrine/Paracetamol approved in United States?

Pseudoephedrine/Paracetamol does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Pseudoephedrine/Paracetamol in United States?

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