FDA — authorised 24 May 1988
- Application: NDA019641
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: TERAZOL 3
- Indication: SUPPOSITORY — VAGINAL
- Status: approved
🇺🇸 TERCONAZOLE in United States
FDA authorised TERCONAZOLE on 24 May 1988 · 534 US adverse-event reports
Marketing authorisations
FDA — authorised 21 February 1991
- Application: NDA019964
- Marketing authorisation holder: JANSSEN PHARMS
- Local brand name: TERAZOL 3
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 6 April 2004
- Application: ANDA075953
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TERCONAZOLE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 1 October 2004
- Application: NDA021735
- Marketing authorisation holder: FOUGERA PHARMS INC
- Local brand name: TERCONAZOLE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 19 January 2005
- Application: ANDA076043
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TERCONAZOLE
- Indication: CREAM — VAGINAL
- Status: approved
FDA — authorised 18 February 2005
- Application: ANDA076712
- Marketing authorisation holder: FOUGERA PHARMS
- Status: approved
FDA — authorised 17 March 2006
- Application: ANDA077149
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: TERCONAZOLE
- Indication: SUPPOSITORY — VAGINAL
- Status: approved
FDA — authorised 12 July 2006
- Application: ANDA076850
- Marketing authorisation holder: FOUGERA PHARMS
- Local brand name: TERCONAZOLE
- Indication: SUPPOSITORY — VAGINAL
- Status: approved
FDA — authorised 9 March 2007
- Application: ANDA077553
- Marketing authorisation holder: SUN PHARMA CANADA
- Local brand name: TERCONAZOLE
- Indication: SUPPOSITORY — VAGINAL
- 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: 20 April 2025 – 20 April 2026
- Total reports: 534
Most-reported reactions
- Pain — 94 reports (17.6%)
- Chronic Kidney Disease — 69 reports (12.92%)
- Drug Ineffective — 55 reports (10.3%)
- Nausea — 52 reports (9.74%)
- Headache — 51 reports (9.55%)
- Anxiety — 49 reports (9.18%)
- Urinary Tract Infection — 45 reports (8.43%)
- Fatigue — 44 reports (8.24%)
- Acute Kidney Injury — 38 reports (7.12%)
- Product Quality Issue — 37 reports (6.93%)
TERCONAZOLE 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 TERCONAZOLE approved in United States?
Yes. FDA authorised it on 24 May 1988; FDA authorised it on 21 February 1991; FDA authorised it on 6 April 2004.
Who is the marketing authorisation holder for TERCONAZOLE in United States?
JANSSEN PHARMS holds the US marketing authorisation.