FDA — authorised 9 January 2006
- Application: NDA021852
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: TACLONEX
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Taclonex in United States
FDA authorised Taclonex on 9 January 2006 · 932 US adverse-event reports
Marketing authorisations
FDA — authorised 9 May 2008
- Application: NDA022185
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: TACLONEX
- Indication: SUSPENSION — TOPICAL
- 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: 932
Most-reported reactions
- Psoriasis — 255 reports (27.36%)
- Drug Ineffective — 128 reports (13.73%)
- Diarrhoea — 96 reports (10.3%)
- Headache — 93 reports (9.98%)
- Nausea — 93 reports (9.98%)
- Rash — 57 reports (6.12%)
- Injection Site Pain — 55 reports (5.9%)
- Pruritus — 53 reports (5.69%)
- Arthralgia — 52 reports (5.58%)
- Fatigue — 50 reports (5.36%)
Taclonex in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Taclonex approved in United States?
Yes. FDA authorised it on 9 January 2006; FDA authorised it on 9 May 2008; FDA has authorised it.
Who is the marketing authorisation holder for Taclonex in United States?
LEO PHARMA AS holds the US marketing authorisation.