FDA — authorised 30 March 1998
- Application: ANDA074823
- Marketing authorisation holder: SENORES PHARMS
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 TERAZOSIN HYDROCHLORIDE in United States
FDA authorised TERAZOSIN HYDROCHLORIDE on 30 March 1998 · 729 US adverse-event reports
Marketing authorisations
FDA — authorised 31 December 1998
- Application: ANDA074315
- Marketing authorisation holder: SANDOZ
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 February 2000
- Application: ANDA075140
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 April 2000
- Application: ANDA074530
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 April 2000
- Application: ANDA074657
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 May 2000
- Application: ANDA074446
- Marketing authorisation holder: TEVA
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2000
- Application: ANDA075667
- Marketing authorisation holder: BIONPHARMA
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 December 2000
- Application: ANDA075384
- Marketing authorisation holder: PHARMOBEDIENT
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 January 2001
- Application: ANDA075614
- Marketing authorisation holder: HERITAGE PHARMA AVET
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2001
- Application: ANDA075498
- Marketing authorisation holder: HIKMA
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 August 2002
- Application: ANDA076021
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 December 2004
- Application: ANDA075317
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 May 2025
- Application: ANDA219482
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: TERAZOSIN HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- 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: 729
Most-reported reactions
- Dyspnoea — 114 reports (15.64%)
- Fatigue — 77 reports (10.56%)
- Constipation — 73 reports (10.01%)
- Dizziness — 72 reports (9.88%)
- Drug Ineffective — 69 reports (9.47%)
- Blood Pressure Increased — 68 reports (9.33%)
- Diarrhoea — 67 reports (9.19%)
- Pneumonia — 66 reports (9.05%)
- Fall — 63 reports (8.64%)
- Asthenia — 60 reports (8.23%)
TERAZOSIN 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 TERAZOSIN HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 March 1998; FDA authorised it on 31 December 1998; FDA authorised it on 11 February 2000.
Who is the marketing authorisation holder for TERAZOSIN HYDROCHLORIDE in United States?
SENORES PHARMS holds the US marketing authorisation.