🇺🇸 Glipizide XL in United States

FDA authorised Glipizide XL on 26 April 1994 · 642 US adverse-event reports

Marketing authorisations

FDA — authorised 26 April 1994

  • Application: NDA020329
  • Marketing authorisation holder: PFIZER
  • Local brand name: GLUCOTROL XL
  • Indication: TABLET, EXTENDED RELEASE — 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. Blood Glucose Increased — 118 reports (18.38%)
  2. Drug Ineffective — 101 reports (15.73%)
  3. Diarrhoea — 71 reports (11.06%)
  4. Nausea — 69 reports (10.75%)
  5. Fatigue — 57 reports (8.88%)
  6. Dizziness — 54 reports (8.41%)
  7. Headache — 51 reports (7.94%)
  8. Dyspnoea — 43 reports (6.7%)
  9. Pain — 41 reports (6.39%)
  10. Weight Decreased — 37 reports (5.76%)

Source database →

Glipizide XL 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 Glipizide XL approved in United States?

Yes. FDA authorised it on 26 April 1994; FDA has authorised it.

Who is the marketing authorisation holder for Glipizide XL in United States?

PFIZER holds the US marketing authorisation.