🇺🇸 Laxative in United States

FDA authorised Laxative on 6 October 2009 · 2,692 US adverse-event reports

Marketing authorisations

FDA — authorised 6 October 2009

  • Application: ANDA090685
  • Marketing authorisation holder: PPI-DAC
  • Status: supplemented

FDA — authorised 7 October 2009

  • Application: ANDA090812
  • Marketing authorisation holder: LGM PHARMA
  • Status: approved

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FDA — authorised 24 August 2016

  • Application: ANDA203928
  • Marketing authorisation holder: STRIDES PHARMA
  • Status: supplemented

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. Constipation — 355 reports (13.19%)
  2. Fatigue — 353 reports (13.11%)
  3. Nausea — 335 reports (12.44%)
  4. Diarrhoea — 298 reports (11.07%)
  5. Drug Ineffective — 289 reports (10.74%)
  6. Pain — 263 reports (9.77%)
  7. Death — 227 reports (8.43%)
  8. Headache — 196 reports (7.28%)
  9. Vomiting — 190 reports (7.06%)
  10. Off Label Use — 186 reports (6.91%)

Source database →

Laxative 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 Laxative approved in United States?

Yes. FDA authorised it on 6 October 2009; FDA authorised it on 7 October 2009; FDA authorised it on 24 August 2016.

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

PPI-DAC holds the US marketing authorisation.