Drug Safety Information for AGGRENOX (Aspirin; dipyridamole)

FDA Safety-related Labeling Changes for AGGRENOX (ASPIRIN; DIPYRIDAMOLE) Rx Drug: Safety Information Link

Adverse Drug Reactions for AGGRENOX* (Aspirin; dipyridamole)

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 AGGRENOX
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Cerebrovascular accident	552
2	Headache*	408
3	Nausea*	275
4	Transient ischaemic attack	245
5	Dizziness	231
6	Vomiting	200
7	Diarrhoea	192
8	Asthenia	173
9	Fall	148
10	Fatigue	142
11	Dyspnoea	141
12	Myocardial infarction	115
13	Pain in extremity	109
14	Pain*	107
15	Hypertension	103
16	Drug ineffective	98
17	Anaemia	98
18	Chest pain	92
19	Renal failure acute	91
20	Pneumonia	90

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

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

	Reason	# of FDA Reports
1	Cerebrovascular accident prophylaxis	1481
2	Product used for unknown indication	1314
3	Transient ischaemic attack*	1023
4	Cerebrovascular accident*	994
5	Prophylaxis	358
6	Anticoagulant therapy	346
7	Thrombosis prophylaxis	110
8	Hypertension	55
9	Essential hypertension	52
10	Antiplatelet therapy	41

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

Types of Adverse Events for AGGRENOX

Total Reports Filed with FDA: 15823

Number of FDA Adverse Event Reports by Patient Age for AGGRENOX

Total Reports Filed with FDA: 15823*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Aspirin; dipyridamole (Aggrenox)

Charts are based on 15823 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.

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.