Drug Safety Information for PLAVIX (Clopidogrel bisulfate)

Safety-related Labeling Changes for PLAVIX (CLOPIDOGREL BISULFATE) Rx Drug: FDA Link

Adverse Drug Reactions for PLAVIX* (Clopidogrel bisulfate)

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 PLAVIX
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Myocardial infarction6443
2Dyspnoea*4154
3Gastrointestinal haemorrhage4143
4Cerebrovascular accident3753
5Nausea3648
6Dizziness*3300
7Chest pain3164
8Asthenia3083
9Drug ineffective2893
10Fatigue*2813
11Pain2699
12Diarrhoea2589
13Fall2562
14Death2542
15Anaemia2463
16Cardiac failure congestive2363
17Coronary artery disease2281
18Vomiting2221
19Headache*2221
20Hypotension2099

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

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

Reason # of FDA Reports
1Product used for unknown indication41728
2Stent placement*8463
3Anticoagulant therapy6209
4Cardiac disorder5097
5Cerebrovascular accident*4281
6Coronary artery disease*4098
7Myocardial infarction*3875
8Prophylaxis3594
9Thrombosis prophylaxis3500
10Coronary arterial stent insertion3392

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


Types of Adverse Events for PLAVIX

Total Reports Filed with FDA: 350703


Number of FDA Adverse Event Reports by Patient Age for PLAVIX

Total Reports Filed with FDA: 350703*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Clopidogrel bisulfate (Iscover, Plavix)

Charts are based on 350703 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 PLAVIX 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.