Drug Safety Information for CARVEDILOL (Carvedilol)

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

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

Adverse Drug Reactions for CARVEDILOL* (Carvedilol)

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 CARVEDILOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea*2908
2Cardiac failure congestive2673
3Dizziness*2446
4Nausea*2262
5Fatigue*2258
6Myocardial infarction2047
7Asthenia1991
8Diarrhoea1713
9Hypotension1711
10Drug ineffective1636
11Pain1471
12Vomiting1410
13Fall1359
14Chest pain1323
15Anaemia1299
16Renal failure acute1285
17Headache*1239
18Pneumonia1224
19Hypertension1219
20Renal failure1194

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

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

Reason # of FDA Reports
1Product used for unknown indication22778
2Hypertension*16748
3Cardiac disorder4808
4Cardiac failure congestive*2492
5Cardiac failure*1767
6Blood pressure*1667
7Atrial fibrillation909
8Cardiomyopathy*775
9Blood pressure abnormal708
10Coronary artery disease538

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


Types of Adverse Events for CARVEDILOL

Total Reports Filed with FDA: 193708


Number of FDA Adverse Event Reports by Patient Age for CARVEDILOL

Total Reports Filed with FDA: 193708*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Carvedilol (Coropres, Eucardic, Dilatrend, Kredex, Querto, Coreg, Carvedilol)

Charts are based on 193708 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 CARVEDILOL 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.