Drug Safety Information for RECLAST (Zoledronic acid)

Safety-related Labeling Changes for ZOLEDRONIC ACID (ZOLEDRONIC ACID) Rx Drug: FDA Link

Adverse Drug Reactions for RECLAST* (Zoledronic acid)

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 RECLAST
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Osteonecrosis7409
2Osteonecrosis of jaw4831
3Death4316
4Pain*3717
5Tooth extraction2667
6Bone disorder2648
7Fatigue*2399
8Pyrexia*2294
9Arthralgia*2289
10Nausea2182
11Neoplasm malignant2171
12Pain in jaw2108
13Dyspnoea1868
14Osteomyelitis1846
15Diarrhoea1798
16Asthenia1747
17Back pain1606
18Bone pain*1587
19Pain in extremity1542
20Vomiting1541

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

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

Reason # of FDA Reports
1Metastases to bone37916
2Multiple myeloma32789
3Osteoporosis*26016
4Breast cancer metastatic12746
5Product used for unknown indication11402
6Breast cancer*9360
7Prostate cancer5654
8Prostate cancer metastatic4446
9Bone disorder3305
10Osteopenia*2871

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


Types of Adverse Events for RECLAST

Total Reports Filed with FDA: 262396


Number of FDA Adverse Event Reports by Patient Age for RECLAST

Total Reports Filed with FDA: 262396*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Zoledronic acid (Zoledronate, Zometa, Reclast, Cgp 42446, Zoledronic acid)

Charts are based on 262396 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 RECLAST Reviews and Review Summary .

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.

Visit   DrugInformer.com more on RECLAST's side effects.