FDA — authorised 18 August 1988
- Application: NDA050592
- Marketing authorisation holder: SANDOZ
- Local brand name: TOBRADEX
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 Tobradex in United States
FDA authorised Tobradex on 18 August 1988 · 1,373 US adverse-event reports
Marketing authorisations
FDA — authorised 28 September 1988
- Application: NDA050616
- Marketing authorisation holder: NOVARTIS
- Local brand name: TOBRADEX
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 13 February 2009
- Application: NDA050818
- Marketing authorisation holder: HARROW EYE
- Status: supplemented
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: 1,373
Most-reported reactions
- Eye Pain — 197 reports (14.35%)
- Off Label Use — 165 reports (12.02%)
- Headache — 134 reports (9.76%)
- Nausea — 134 reports (9.76%)
- Vision Blurred — 133 reports (9.69%)
- Fatigue — 129 reports (9.4%)
- Drug Ineffective — 124 reports (9.03%)
- Ocular Hyperaemia — 124 reports (9.03%)
- Eye Irritation — 119 reports (8.67%)
- Pain — 114 reports (8.3%)
Tobradex 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 Tobradex approved in United States?
Yes. FDA authorised it on 18 August 1988; FDA authorised it on 28 September 1988; FDA authorised it on 13 February 2009.
Who is the marketing authorisation holder for Tobradex in United States?
SANDOZ holds the US marketing authorisation.