FDA — authorised 2 October 2012
- Application: NDA200740
- Marketing authorisation holder: LEADIANT BIOSCI INC
- Local brand name: CYSTARAN
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
🇺🇸 CYSTEAMINE HYDROCHLORIDE in United States
FDA authorised CYSTEAMINE HYDROCHLORIDE on 2 October 2012 · 36 US adverse-event reports
Marketing authorisations
FDA — authorised 19 August 2020
- Application: NDA211302
- Marketing authorisation holder: RECORDATI RARE
- Indication: Type 5 - New Formulation or New Manufacturer
- 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: 36
Most-reported reactions
- Amino Acid Level Increased — 6 reports (16.67%)
- Diarrhoea — 4 reports (11.11%)
- Off Label Use — 4 reports (11.11%)
- Pneumonia — 4 reports (11.11%)
- Death — 3 reports (8.33%)
- Decreased Appetite — 3 reports (8.33%)
- Dehydration — 3 reports (8.33%)
- Dyspnoea — 3 reports (8.33%)
- Hypocalcaemia — 3 reports (8.33%)
- Renal Impairment — 3 reports (8.33%)
CYSTEAMINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Ophthalmology approved in United States
Frequently asked questions
Is CYSTEAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 October 2012; FDA authorised it on 19 August 2020.
Who is the marketing authorisation holder for CYSTEAMINE HYDROCHLORIDE in United States?
LEADIANT BIOSCI INC holds the US marketing authorisation.