Drug Safety Information for CARDURA (Doxazosin mesylate)

Safety-related Labeling Changes for CARDURA (DOXAZOSIN MESYLATE) Rx Drug: FDA Link

Safety-related Labeling Changes for CARDURA XL (DOXAZOSIN MESYLATE) Rx Drug: FDA Link

Adverse Drug Reactions for CARDURA* (Doxazosin mesylate)

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 CARDURA
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea776
2Dizziness*742
3Drug ineffective695
4Diarrhoea645
5Drug interaction610
6Asthenia608
7Fatigue*603
8Hypotension596
9Nausea594
10Hypertension477
11Renal failure acute473
12Vomiting470
13Fall454
14Headache*451
15Oedema peripheral437
16Malaise428
17Pain428
18Anaemia393
19Renal failure383
20Arthralgia363

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

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

Reason # of FDA Reports
1Hypertension*9511
2Product used for unknown indication6904
3Benign prostatic hyperplasia*1534
4Prostatic disorder716
5Blood pressure*659
6Essential hypertension395
7Ill-defined disorder357
8Blood pressure increased333
9Prostatomegaly*311
10Dysuria222

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


Types of Adverse Events for CARDURA

Total Reports Filed with FDA: 65029


Number of FDA Adverse Event Reports by Patient Age for CARDURA

Total Reports Filed with FDA: 65029*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Doxazosin mesylate (Cardura xl, Apo-doxazosin, Doxacor, Doxazosina, Zoxan, Doxazosin mesilate, Doxazosin, Cardular, Carduran neo, Doxagamma, Cardura, Diblocin, Doxazomerck, Carduran, Doxazosin mesylate)

Charts are based on 65029 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 CARDURA Reviews and Review Summary .

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.

Visit   DrugInformer.com more on CARDURA's side effects.