Drug Safety Information for DIDRONEL (Etidronate disodium)

Adverse Drug Reactions for DIDRONEL* (Etidronate 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 DIDRONEL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Fall53
2Femur fracture43
3Nausea32
4Diarrhoea32
5Dyspnoea32
6Vomiting28
7Pyrexia27
8Urinary tract infection27
9Asthenia26
10Osteonecrosis26
11Chronic obstructive pulmonary disease26
12Arthralgia26
13Pain in extremity25
14Fatigue25
15Pain25
16Dizziness24
17Condition aggravated24
18Rheumatoid arthritis24
19Pneumonia23
20Abdominal pain23

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

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

Reason # of FDA Reports
1Osteoporosis1147
2Product used for unknown indication385
3Osteopenia175
4Osteoporosis prophylaxis70
5Osteoporosis postmenopausal55
6Calcification metastatic31
7Rheumatoid arthritis25
8Osteitis deformans16
9Menopause14
10Neck pain13

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


Types of Adverse Events for DIDRONEL

Total Reports Filed with FDA: 4191


Number of FDA Adverse Event Reports by Patient Age for DIDRONEL

Total Reports Filed with FDA: 4191*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Etidronate disodium (Didronel, Etidronate disodium, Etidronic acid)

Charts are based on 4191 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 DIDRONEL 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.