Drug Safety Information for RISEDRONATE SODIUM (Risedronate sodium)

Safety-related Labeling Changes for ACTONEL (RISEDRONATE SODIUM) Rx Drug: FDA Link

Safety-related Labeling Changes for ATELVIA (RISEDRONATE SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for RISEDRONATE SODIUM* (Risedronate sodium)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with RISEDRONATE SODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Arthralgia*1239
2Fall1221
3Femur fracture1062
4Nausea1060
5Pain*941
6Pain in extremity883
7Fatigue813
8Dyspnoea771
9Diarrhoea*760
10Headache*753
11Dizziness735
12Back pain*715
13Drug ineffective713
14Asthenia683
15Vomiting654
16Pyrexia564
17Oedema peripheral545
18Myalgia*536
19Chest pain530
20Hypertension521

* This side effect also appears in "Top 10 Side Effects of RISEDRONATE SODIUM " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking RISEDRONATE SODIUM
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Osteoporosis*22900
2Osteopenia*9263
3Product used for unknown indication6145
4Osteoporosis prophylaxis2220
5Bone disorder848
6Prophylaxis724
7Bone density decreased580
8Osteoporosis postmenopausal408
9Rheumatoid arthritis292
10Osteoarthritis267

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for RISEDRONATE SODIUM

Total Reports Filed with FDA: 97155


Number of FDA Adverse Event Reports by Patient Age for RISEDRONATE SODIUM

Total Reports Filed with FDA: 97155*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Risedronate sodium (Atelvia, Risedronic acid, Risedronate sodium, Actonel)

Charts are based on 97155 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and RISEDRONATE SODIUM Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.