FDA — authorised 31 October 1991
- Application: NDA020036
- Marketing authorisation holder: NOVARTIS
- Local brand name: AREDIA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 pamidronate in United States
FDA authorised pamidronate on 31 October 1991 · 3,555 US adverse-event reports
Marketing authorisations
FDA — authorised 22 September 1998
- Application: NDA020927
- Marketing authorisation holder: NOVARTIS
- Local brand name: AREDIA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 June 2002
- Application: ANDA075841
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 31 October 2008
- Application: ANDA078520
- Marketing authorisation holder: MYLAN LABS LTD
- 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: 3,555
Most-reported reactions
- Osteonecrosis Of Jaw — 636 reports (17.89%)
- Osteonecrosis — 569 reports (16.01%)
- Pain — 504 reports (14.18%)
- Drug Ineffective — 298 reports (8.38%)
- Fatigue — 287 reports (8.07%)
- Off Label Use — 274 reports (7.71%)
- Diarrhoea — 266 reports (7.48%)
- Nausea — 253 reports (7.12%)
- Pneumonia — 246 reports (6.92%)
- Pyrexia — 222 reports (6.24%)
pamidronate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is pamidronate approved in United States?
Yes. FDA authorised it on 31 October 1991; FDA authorised it on 22 September 1998; FDA authorised it on 27 June 2002.
Who is the marketing authorisation holder for pamidronate in United States?
NOVARTIS holds the US marketing authorisation.