Drug Safety Information for ENOXAPARIN SODIUM (Enoxaparin sodium)

Safety-related Labeling Changes for LOVENOX (ENOXAPARIN SODIUM) Rx Drug: FDA Link

Adverse Drug Reactions for ENOXAPARIN SODIUM* (Enoxaparin 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 ENOXAPARIN SODIUM
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea1439
2Anaemia1411
3Pulmonary embolism1381
4Nausea*1323
5Death1258
6Thrombocytopenia1237
7Pyrexia1215
8Deep vein thrombosis1196
9Hypotension1161
10Pneumonia1093
11Vomiting1074
12Pain*1071
13Haemoglobin decreased1071
14Diarrhoea*1061
15Renal failure acute1017
16Asthenia961
17Fatigue*910
18Renal failure890
19Haemorrhage851
20Fall786

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

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

Reason # of FDA Reports
1Product used for unknown indication16466
2Thrombosis prophylaxis9178
3Deep vein thrombosis*4262
4Pulmonary embolism*3739
5Prophylaxis3429
6Anticoagulant therapy2732
7Thrombosis*2395
8Atrial fibrillation1943
9Myocardial infarction967
10Acute coronary syndrome562

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


Types of Adverse Events for ENOXAPARIN SODIUM

Total Reports Filed with FDA: 147911


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

Total Reports Filed with FDA: 147911*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Enoxaparin sodium (Clexane, Enoxaparin sodium, Lovenox)

Charts are based on 147911 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 ENOXAPARIN 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.