FDA — authorised 1 October 1984
- Application: NDA018796
- Marketing authorisation holder: ALCON
- Local brand name: PILOPINE HS
- Indication: GEL — OPHTHALMIC
- Status: approved
🇺🇸 PILOCARPINE HYDROCHLORIDE in United States
FDA authorised PILOCARPINE HYDROCHLORIDE on 1 October 1984 · 836 US adverse-event reports
Marketing authorisations
FDA — authorised 16 November 2004
- Application: ANDA076746
- Marketing authorisation holder: PADAGIS US
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 December 2004
- Application: ANDA076963
- Marketing authorisation holder: INNOGENIX
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 14 October 2005
- Application: ANDA077220
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 31 March 2006
- Application: ANDA077248
- Marketing authorisation holder: IMPAX LABS
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 September 2017
- Application: ANDA204398
- Marketing authorisation holder: RISING
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 13 August 2019
- Application: ANDA212377
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 2019
- Application: ANDA210384
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 21 September 2020
- Application: ANDA214193
- Marketing authorisation holder: AMNEAL
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 28 April 2025
- Application: ANDA217733
- Marketing authorisation holder: AMNEAL
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 2 October 2025
- Application: ANDA217052
- Marketing authorisation holder: FDC LTD
- Local brand name: PILOCARPINE HYDROCHLORIDE
- Indication: SOLUTION/DROPS — OPHTHALMIC
- 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: 836
Most-reported reactions
- Drug Ineffective — 125 reports (14.95%)
- Fatigue — 90 reports (10.77%)
- Eye Pain — 88 reports (10.53%)
- Headache — 87 reports (10.41%)
- Pain — 85 reports (10.17%)
- Dyspnoea — 82 reports (9.81%)
- Diarrhoea — 72 reports (8.61%)
- Dizziness — 72 reports (8.61%)
- Nausea — 69 reports (8.25%)
- Fall — 66 reports (7.89%)
PILOCARPINE HYDROCHLORIDE 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 PILOCARPINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 1 October 1984; FDA authorised it on 16 November 2004; FDA authorised it on 22 December 2004.
Who is the marketing authorisation holder for PILOCARPINE HYDROCHLORIDE in United States?
ALCON holds the US marketing authorisation.