FDA — authorised 28 January 2011
- Application: NDA022544
- Marketing authorisation holder: ALMATICA
- Local brand name: GRALISE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Gralise in United States
FDA authorised Gralise on 28 January 2011 · 3,649 US adverse-event reports
Marketing authorisations
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: 27 March 2025 – 27 March 2026
- Total reports: 3,649
Most-reported reactions
- Product Use In Unapproved Indication — 1,157 reports (31.71%)
- Drug Titration Error — 487 reports (13.35%)
- Product Use Issue — 373 reports (10.22%)
- Dizziness — 339 reports (9.29%)
- Fatigue — 273 reports (7.48%)
- Somnolence — 266 reports (7.29%)
- Drug Ineffective — 199 reports (5.45%)
- Off Label Use — 191 reports (5.23%)
- Drug Ineffective For Unapproved Indication — 190 reports (5.21%)
- Product Dose Omission Issue — 174 reports (4.77%)
Other Other approved in United States
Frequently asked questions
Is Gralise approved in United States?
Yes. FDA authorised it on 28 January 2011; FDA has authorised it.
Who is the marketing authorisation holder for Gralise in United States?
ALMATICA holds the US marketing authorisation.