FDA — authorised 7 February 1997
- Application: NDA019881
- Marketing authorisation holder: PADAGIS US
- Local brand name: BUTOCONAZOLE NITRATE
- Indication: CREAM — VAGINAL
- Status: approved
🇺🇸 BUTOCONAZOLE NITRATE in United States
FDA authorised BUTOCONAZOLE NITRATE on 7 February 1997 · 15 US adverse-event reports
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA019215
- Marketing authorisation holder: ROCHE PALO
- Local brand name: FEMSTAT
- Indication: CREAM — VAGINAL
- Status: approved
FDA
- Application: NDA019359
- Marketing authorisation holder: ROCHE PALO
- Local brand name: FEMSTAT
- Indication: SUPPOSITORY — VAGINAL
- 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: 20 April 2025 – 20 April 2026
- Total reports: 15
Most-reported reactions
- Atypical Femur Fracture — 2 reports (13.33%)
- Low Turnover Osteopathy — 2 reports (13.33%)
- Maternal Drugs Affecting Foetus — 2 reports (13.33%)
- Pain In Extremity — 2 reports (13.33%)
- Stress Fracture — 2 reports (13.33%)
- Abdominal Pain — 1 report (6.67%)
- Amniotic Fluid Volume Increased — 1 report (6.67%)
- Atrial Septal Defect — 1 report (6.67%)
- Breech Delivery — 1 report (6.67%)
- Bruxism — 1 report (6.67%)
BUTOCONAZOLE NITRATE 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 BUTOCONAZOLE NITRATE approved in United States?
Yes. FDA authorised it on 7 February 1997; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for BUTOCONAZOLE NITRATE in United States?
PADAGIS US holds the US marketing authorisation.