🇺🇸 Synthroid in United States

FDA authorised Synthroid on 24 July 2002 · 111,497 US adverse-event reports

Marketing authorisations

FDA — authorised 24 July 2002

  • Application: NDA021402
  • Marketing authorisation holder: ABBVIE
  • Local brand name: SYNTHROID
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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. Fatigue — 16,043 reports (14.39%)
  2. Drug Ineffective — 14,055 reports (12.61%)
  3. Nausea — 13,598 reports (12.2%)
  4. Headache — 11,442 reports (10.26%)
  5. Diarrhoea — 10,778 reports (9.67%)
  6. Pain — 10,257 reports (9.2%)
  7. Dyspnoea — 9,201 reports (8.25%)
  8. Dizziness — 9,166 reports (8.22%)
  9. Off Label Use — 8,526 reports (7.65%)
  10. Arthralgia — 8,431 reports (7.56%)

Source database →

Synthroid in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Synthroid approved in United States?

Yes. FDA authorised it on 24 July 2002; FDA has authorised it.

Who is the marketing authorisation holder for Synthroid in United States?

ABBVIE holds the US marketing authorisation.