PLAVIX FDA MedWatch Voluntary U.S. Reports Summary

These tables and charts are created from 2,604 U.S. reports for PLAVIX (CLOPIDOGREL BISULFATE) voluntarily reported by individuals directly to the FDA via the MedWatch Reporting System from 2004 through July 30, 2026. Events listed on this page represent serious and often rare adverse events reported to the FDA, and often do not represent typical side effects for the medication. Find common side effects on the most recent official drug label.

For a summary of adverse events including mandatory reports submitted by pharmaceutical companies (all countries and all reporter types) to the FAERS database, View FDA FAERS PLAVIX Report.

Top Adverse Events Reported with PLAVIX (from U.S. FDA Medwatch Reports)

	Side Effect	# of FDA Reports
1	DEATH	188
2	SHORTNESS OF BREATH	126
3	NAUSEA	118
4	DIZZINESS	106
5	DIARRHEA	104
6	FATIGUE	103
7	HEADACHE	96
8	STROKE	93
9	LACK OF STRENGTH AND ENERGY (ASTHENIA)	91
10	HEART ATTACK (MYOCARDIAL INFARCTION)	78
11	FALL	73
12	RASH	73
13	THERAPY CESSATION	73
14	JOINT PAIN	71
15	PAIN	71
16	VOMITING	69
17	ITCHING	65
18	DRUG INEFFECTIVE	59
19	THERAPY INTERRUPTED	58
20	GASTROINTESTINAL BLEEDING	57
21	CHEST PAIN	56
22	ANEMIA	54
23	PRODUCT SUBSTITUTION ISSUE	54
24	HOSPITALIZATION	52
25	PAIN IN EXTREMITY	52

Search all MedWatch Reports by Keyword:

PLAVIX Total Medwatch Safety Reports by Patient Sex

Male	Female	Unknown	Total
1338	1207	59	2,604

Medwatch Reporter Type	Count
Consumer	861
Physician	113
Pharmacist	640
Other Health Professional	461
Lawyer	1

Top Indications

HEART ATTACK
Product used for unknown indication
STROKE
Antiplatelet therapy
Anticoagulant therapy

Type of Outcome Reported
Serious: 2069
Not Serious: 535
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Suspected Role
Primary Suspect: 2604
Concomitant Drugs: 2421
Note: A single MedWatch report can list more than one drug. This summary includes PLAVIX identified as the suspect drug or as a concomitantly taken drug.

FDA Safety-Related Labeling Changes

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

Have experience (good or bad) with PLAVIX? Rate PLAVIX at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

NOTES

This report, created by AskaPatient.com, is derived from U.S. drug-related adverse event cases that were reported directly to the FDA using the voluntary MedWatch online or paper reporting system. MedWatch is the voluntary FDA system for consumers, physicians, and others to directly report adverse reactions. The Medwatch initiative was launched in 1993 as a voluntary reporting program for consumers, physicians and other healthcare practitioners.

After processing the received forms, the FDA adds the MedWatch reports to the FDA Adverse Events Reporting System(or FAERS database.) Click here for the complete FAERS report summary, which includes mandatory reports submitted by pharmaceutical companies (worldwide) combined with the MedWatch reports. MedWatch Reports only represent about 5% of the FAERS database. For more, read "Does the FDA's Rapidly Growing Database of Adverse Events Improve Drug Safety?"

The data in this report was obtained from Open FDA. Data was last updated to include reports through January 27, 2026. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event.

Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on Open FDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions about this report.