FDA — authorised 26 May 2000
- Application: NDA021176
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Welchol in United States
FDA authorised Welchol on 26 May 2000 · 5,551 US adverse-event reports
Marketing authorisations
FDA — authorised 26 May 2000
- Application: NDA021141
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 October 2009
- Application: NDA022362
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 3 April 2019
- Application: NDA210895
- Marketing authorisation holder: COSETTE
- Local brand name: WELCHOL
- Indication: BAR, CHEWABLE — ORAL
- 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.
- Window: 28 March 2025 – 28 March 2026
- Total reports: 5,551
Most-reported reactions
- Off Label Use — 1,324 reports (23.85%)
- No Adverse Event — 913 reports (16.45%)
- Diarrhoea — 628 reports (11.31%)
- Nausea — 488 reports (8.79%)
- Fatigue — 473 reports (8.52%)
- Drug Ineffective — 390 reports (7.03%)
- Constipation — 374 reports (6.74%)
- Headache — 352 reports (6.34%)
- Pain — 312 reports (5.62%)
- Weight Decreased — 297 reports (5.35%)
Other Metabolic approved in United States
Frequently asked questions
Is Welchol approved in United States?
Yes. FDA authorised it on 26 May 2000; FDA authorised it on 26 May 2000; FDA authorised it on 2 October 2009.
Who is the marketing authorisation holder for Welchol in United States?
COSETTE holds the US marketing authorisation.