Drug Safety Information for AREDIA (Pamidronate disodium)

Adverse Drug Reactions for AREDIA* (Pamidronate disodium)

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 AREDIA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Osteonecrosis2425
2Osteonecrosis of jaw1258
3Pain*1158
4Bone disorder1056
5Tooth extraction1051
6Osteomyelitis806
7Pain in jaw677
8Fatigue*601
9Anxiety601
10Anaemia573
11Impaired healing573
12Dyspnoea567
13Neoplasm malignant526
14Nausea*526
15Back pain494
16Diarrhoea492
17Pyrexia*485
18Pneumonia480
19Infection476
20Death473

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

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

Reason # of FDA Reports
1Multiple myeloma*16304
2Metastases to bone11917
3Product used for unknown indication4037
4Breast cancer metastatic*3560
5Breast cancer2972
6Osteoporosis*2665
7Hypercalcaemia2538
8Bone loss1061
9Hypercalcaemia of malignancy950
10Bone disorder731

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


Types of Adverse Events for AREDIA

Total Reports Filed with FDA: 97971


Number of FDA Adverse Event Reports by Patient Age for AREDIA

Total Reports Filed with FDA: 97971*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Pamidronate disodium (Apd, Pamidronic acid, Pamidronate, Pamidronate disodium, Disodium pamidronate, Aredia)

Charts are based on 97971 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 AREDIA 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.