FDA — authorised 8 July 1997
- Application: ANDA074425
- Marketing authorisation holder: RISING
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 PENTOXIFYLLINE in United States
FDA authorised PENTOXIFYLLINE on 8 July 1997 · 3,878 US adverse-event reports
Marketing authorisations
FDA — authorised 8 July 1997
- Application: ANDA074877
- Marketing authorisation holder: HERITAGE
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 July 1997
- Application: ANDA074878
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 20 July 1998
- Application: ANDA075028
- Marketing authorisation holder: BAUSCH
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 31 March 1999
- Application: ANDA074962
- Marketing authorisation holder: UPSHER SMITH LABS
- Local brand name: PENTOXIL
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 25 May 1999
- Application: ANDA074874
- Marketing authorisation holder: PLIVA
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 9 June 1999
- Application: ANDA075191
- Marketing authorisation holder: APOTEX
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 3 September 1999
- Application: ANDA075199
- Marketing authorisation holder: ANI PHARMS
- Local brand name: PENTOXIFYLLINE
- Indication: TABLET, EXTENDED RELEASE — 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: 3,878
Most-reported reactions
- Fatigue — 455 reports (11.73%)
- Diarrhoea — 447 reports (11.53%)
- Dyspnoea — 410 reports (10.57%)
- Drug Ineffective — 400 reports (10.31%)
- Fall — 383 reports (9.88%)
- Dizziness — 370 reports (9.54%)
- Nausea — 365 reports (9.41%)
- Asthenia — 355 reports (9.15%)
- Headache — 349 reports (9%)
- Insomnia — 344 reports (8.87%)
PENTOXIFYLLINE 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 PENTOXIFYLLINE approved in United States?
Yes. FDA authorised it on 8 July 1997; FDA authorised it on 8 July 1997; FDA authorised it on 9 July 1997.
Who is the marketing authorisation holder for PENTOXIFYLLINE in United States?
RISING holds the US marketing authorisation.