FDA — authorised 11 March 1998
- Application: ANDA040235
- Marketing authorisation holder: HIKMA
- Status: approved
🇺🇸 PHENTOLAMINE in United States
FDA authorised PHENTOLAMINE on 11 March 1998 · 169 US adverse-event reports
Marketing authorisations
FDA — authorised 26 January 2015
- Application: NDA022159
- Marketing authorisation holder: SEPTODONT HOLDING
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 14 July 2017
- Application: ANDA207686
- Marketing authorisation holder: PRECISION DOSE INC
- Status: approved
FDA — authorised 25 September 2023
- Application: NDA217064
- Marketing authorisation holder: FAMYGEN LIFE SCI
- Indication: Type 3 - New Dosage Form
- 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: 169
Most-reported reactions
- Drug Ineffective — 29 reports (17.16%)
- Blood Glucose Increased — 17 reports (10.06%)
- Pain — 17 reports (10.06%)
- Blood Urea Increased — 16 reports (9.47%)
- Diarrhoea — 16 reports (9.47%)
- Hypotension — 16 reports (9.47%)
- Neutrophil Count Increased — 15 reports (8.88%)
- Priapism — 15 reports (8.88%)
- Anaemia — 14 reports (8.28%)
- Lymphocyte Count Decreased — 14 reports (8.28%)
PHENTOLAMINE 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 PHENTOLAMINE approved in United States?
Yes. FDA authorised it on 11 March 1998; FDA authorised it on 26 January 2015; FDA authorised it on 14 July 2017.
Who is the marketing authorisation holder for PHENTOLAMINE in United States?
HIKMA holds the US marketing authorisation.