Drug Safety Information for TERAZOSIN Hydrochloride (Terazosin hydrochloride)

Adverse Drug Reactions for TERAZOSIN Hydrochloride* (Terazosin hydrochloride)

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 TERAZOSIN Hydrochloride
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness*682
2Dyspnoea*480
3Hypotension474
4Drug ineffective460
5Asthenia422
6Fatigue*398
7Nausea393
8Diarrhoea375
9Syncope*355
10Fall333
11Pain284
12Myocardial infarction256
13Headache253
14Pneumonia251
15Oedema peripheral250
16Chest pain236
17Cardiac failure congestive218
18Anaemia215
19Renal failure acute212
20Cerebrovascular accident211

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

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

Reason # of FDA Reports
1Product used for unknown indication2876
2Hypertension*2181
3Benign prostatic hyperplasia*1985
4Prostatic disorder562
5Prostatomegaly*544
6Blood pressure287
7Prostatitis139
8Dysuria120
9Urinary tract disorder102
10Urinary retention83

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


Types of Adverse Events for TERAZOSIN Hydrochloride

Total Reports Filed with FDA: 39240


Number of FDA Adverse Event Reports by Patient Age for TERAZOSIN Hydrochloride

Total Reports Filed with FDA: 39240*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Terazosin hydrochloride (Hytrine, Terazosin, Magnurol, Flotrin, Dysalfa, Terazosina, Novo-terazosin, Hytrin)

Charts are based on 39240 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 TERAZOSIN Hydrochloride 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.