Drug Safety Information for COREG CR (Carvedilol phosphate)

FDA Safety-related Labeling Changes for COREG CR (CARVEDILOL PHOSPHATE) Rx Drug: Safety Information Link

Adverse Drug Reactions for COREG CR* (Carvedilol phosphate)

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 COREG CR
(reported in FDA Medwatch/FAERS Reports)

	Side Effect	# of FDA Reports
1	Dizziness	250
2	Fatigue	234
3	Drug ineffective	200
4	Dyspnoea	148
5	Blood pressure increased	107
6	Headache	101
7	Nausea	97
8	Hypotension	93
9	Diarrhoea	78
10	Weight increased	75
11	Malaise	72
12	Asthenia	66
13	Feeling abnormal	58
14	Product quality issue	57
15	Blood pressure decreased	57
16	Insomnia	52
17	Pain in extremity	52
18	Palpitations	52
19	Myocardial infarction	51
20	Hypertension	51

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

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

	Reason	# of FDA Reports
1	Hypertension	1908
2	Product used for unknown indication	1135
3	Cardiac disorder	223
4	Cardiac failure congestive	193
5	Cardiomyopathy	111
6	Left ventricular dysfunction	91
7	Arrhythmia	82
8	Blood pressure	76
9	Atrial fibrillation	59
10	Blood pressure abnormal	56

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

Types of Adverse Events for COREG CR

Total Reports Filed with FDA: 6638

Number of FDA Adverse Event Reports by Patient Age for COREG CR

Total Reports Filed with FDA: 6638*

* Reports for drugs with the same active ingredients have been aggregated in this analysis: Carvedilol phosphate (Coreg cr, Coregcr)

Charts are based on 6638 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.