🇺🇸 Levothyroxine Tablet in United States

FDA authorised Levothyroxine Tablet on 13 October 2006 · 67 US adverse-event reports

Marketing authorisation

FDA — authorised 13 October 2006

  • Application: NDA021924
  • Marketing authorisation holder: IBSA
  • Local brand name: TIROSINT
  • Indication: CAPSULE — ORAL
  • Status: approved

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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 — 13 reports (19.4%)
  2. Nausea — 10 reports (14.93%)
  3. Headache — 7 reports (10.45%)
  4. Off Label Use — 7 reports (10.45%)
  5. Drug Ineffective — 6 reports (8.96%)
  6. Malaise — 6 reports (8.96%)
  7. Pain — 5 reports (7.46%)
  8. Rash — 5 reports (7.46%)
  9. Arthralgia — 4 reports (5.97%)
  10. Asthenia — 4 reports (5.97%)

Source database →

Other Endocrinology approved in United States

Frequently asked questions

Is Levothyroxine Tablet approved in United States?

Yes. FDA authorised it on 13 October 2006.

Who is the marketing authorisation holder for Levothyroxine Tablet in United States?

IBSA holds the US marketing authorisation.