🇺🇸 Paracetamol 1 g in United States

11 US adverse-event reports

Marketing authorisation

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. Pyrexia — 2 reports (18.18%)
  2. Abdominal Pain — 1 report (9.09%)
  3. Abdominal Pain Upper — 1 report (9.09%)
  4. Acute Kidney Injury — 1 report (9.09%)
  5. Arthralgia — 1 report (9.09%)
  6. Blood Chloride Decreased — 1 report (9.09%)
  7. Blood Potassium Increased — 1 report (9.09%)
  8. Blood Sodium Decreased — 1 report (9.09%)
  9. Colitis Ischaemic — 1 report (9.09%)
  10. Condition Aggravated — 1 report (9.09%)

Source database →

Paracetamol 1 g 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 Paracetamol 1 g approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Paracetamol 1 g in United States?

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