🇺🇸 PHENYL AMINOSALICYLATE in United States

40 US adverse-event reports

Marketing authorisations

FDA

  • Status: approved

FDA

  • Application: NDA011695
  • Marketing authorisation holder: PHARM RES ASSOC
  • Local brand name: PHENY-PAS-TEBAMIN
  • Indication: POWDER — ORAL
  • Status: approved

Read official source →

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.

Most-reported reactions

  1. Atrial Fibrillation — 4 reports (10%)
  2. Brain Natriuretic Peptide Increased — 4 reports (10%)
  3. Cardiac Disorder — 4 reports (10%)
  4. Chest Discomfort — 4 reports (10%)
  5. Coronary Artery Disease — 4 reports (10%)
  6. Cough — 4 reports (10%)
  7. Dysphonia — 4 reports (10%)
  8. Dyspnoea — 4 reports (10%)
  9. Dyspnoea Exertional — 4 reports (10%)
  10. Eosinophilia — 4 reports (10%)

Source database →

PHENYL AMINOSALICYLATE 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 PHENYL AMINOSALICYLATE approved in United States?

Yes. FDA has authorised it; FDA has authorised it.

Who is the marketing authorisation holder for PHENYL AMINOSALICYLATE in United States?

Marketing authorisation holder not available in our data.