Drug Landscape ›
Pseudoephedrine 60 MG ›
Regulatory · United States
Marketing authorisation
FDA
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: 20 April 2025 – 20 April 2026
Total reports: 10
Most-reported reactions
Alanine Aminotransferase Increased — 1 report (10%) Aspartate Aminotransferase Increased — 1 report (10%) Confusional State — 1 report (10%) Cough — 1 report (10%) Eye Rolling — 1 report (10%) Fracture — 1 report (10%) Intraventricular Haemorrhage — 1 report (10%) Myoclonus — 1 report (10%) Subdural Haemorrhage — 1 report (10%) Tremor — 1 report (10%)
Source database →
Pseudoephedrine 60 MG in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Pseudoephedrine 60 MG approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Pseudoephedrine 60 MG in United States?
University of Maryland, Baltimore is the originator. The local marketing authorisation holder may differ — check the official source linked above.