🇺🇸 PSEUDOEPHEDRINE SULFATE in United States

FDA authorised PSEUDOEPHEDRINE SULFATE on 30 October 1980 · 835 US adverse-event reports

Marketing authorisations

FDA — authorised 30 October 1980

  • Application: NDA018191
  • Marketing authorisation holder: SCHERING PLOUGH
  • Local brand name: AFRINOL
  • Indication: TABLET, EXTENDED RELEASE — ORAL
  • Status: approved

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FDA — authorised 22 September 2004

  • Application: ANDA076557
  • Marketing authorisation holder: SUN PHARM INDS LTD
  • Status: supplemented

FDA

  • Status: approved

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. Drug Ineffective — 266 reports (31.86%)
  2. Insomnia — 128 reports (15.33%)
  3. Headache — 64 reports (7.66%)
  4. Dizziness — 63 reports (7.54%)
  5. Off Label Use — 59 reports (7.07%)
  6. Fatigue — 58 reports (6.95%)
  7. Nausea — 55 reports (6.59%)
  8. Dyspnoea — 52 reports (6.23%)
  9. Anxiety — 48 reports (5.75%)
  10. Somnolence — 42 reports (5.03%)

Source database →

PSEUDOEPHEDRINE SULFATE 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 SULFATE approved in United States?

Yes. FDA authorised it on 30 October 1980; FDA authorised it on 22 September 2004; FDA has authorised it.

Who is the marketing authorisation holder for PSEUDOEPHEDRINE SULFATE in United States?

SCHERING PLOUGH holds the US marketing authorisation.