FDA — authorised 27 March 1998
- Application: NDA020835
- Marketing authorisation holder: APIL
- Indication: Labeling
- Status: approved
🇺🇸 Risedronate in United States
FDA authorised Risedronate on 27 March 1998 · 23,557 US adverse-event reports
Marketing authorisations
FDA — authorised 8 October 2010
- Application: NDA022560
- Marketing authorisation holder: APIL
- Indication: Labeling
- Status: approved
FDA — authorised 30 November 2015
- Application: ANDA200296
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Indication: Not Applicable
- Status: approved
FDA — authorised 9 December 2015
- Application: ANDA203533
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 9 July 2019
- Application: ANDA203925
- Marketing authorisation holder: SUN PHARM
- 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: 23,557
Most-reported reactions
- Drug Ineffective — 2,863 reports (12.15%)
- Off Label Use — 2,756 reports (11.7%)
- Pain — 2,717 reports (11.53%)
- Arthralgia — 2,402 reports (10.2%)
- Dyspnoea — 2,234 reports (9.48%)
- Vomiting — 2,199 reports (9.33%)
- Drug Hypersensitivity — 2,163 reports (9.18%)
- Fatigue — 2,125 reports (9.02%)
- Pneumonia — 2,050 reports (8.7%)
- Nausea — 2,048 reports (8.69%)
Risedronate in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Bone approved in United States
Frequently asked questions
Is Risedronate approved in United States?
Yes. FDA authorised it on 27 March 1998; FDA authorised it on 8 October 2010; FDA authorised it on 30 November 2015.
Who is the marketing authorisation holder for Risedronate in United States?
APIL holds the US marketing authorisation.