🇺🇸 ESOMEPRAZOLE MAGNESIUM in United States

FDA authorised ESOMEPRAZOLE MAGNESIUM on 15 May 2018 · 14,235 US adverse-event reports

Marketing authorisations

FDA — authorised 15 May 2018

  • Application: ANDA207673
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 10 May 2019

  • Application: ANDA209495
  • Marketing authorisation holder: GLENMARK SPECLT
  • Status: supplemented

FDA — authorised 14 May 2020

  • Application: ANDA211571
  • Marketing authorisation holder: DR REDDYS
  • Status: approved

FDA — authorised 26 February 2021

  • Application: ANDA210559
  • Marketing authorisation holder: INDCHEMIE HEALTH
  • Status: supplemented

FDA — authorised 5 March 2025

  • Application: ANDA212651
  • Marketing authorisation holder: TORRENT
  • Status: approved

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 — 2,051 reports (14.41%)
  2. Nausea — 1,817 reports (12.76%)
  3. Diarrhoea — 1,455 reports (10.22%)
  4. Fatigue — 1,442 reports (10.13%)
  5. Headache — 1,411 reports (9.91%)
  6. Pain — 1,304 reports (9.16%)
  7. Dyspnoea — 1,298 reports (9.12%)
  8. Arthralgia — 1,238 reports (8.7%)
  9. Off Label Use — 1,180 reports (8.29%)
  10. Malaise — 1,039 reports (7.3%)

Source database →

ESOMEPRAZOLE MAGNESIUM 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 ESOMEPRAZOLE MAGNESIUM approved in United States?

Yes. FDA authorised it on 15 May 2018; FDA authorised it on 10 May 2019; FDA authorised it on 14 May 2020.

Who is the marketing authorisation holder for ESOMEPRAZOLE MAGNESIUM in United States?

DR REDDYS holds the US marketing authorisation.