Drug Safety Information for ALFUZOSIN HYDROCHLORIDE (Alfuzosin hydrochloride)

Safety-related Labeling Changes for UROXATRAL (ALFUZOSIN HYDROCHLORIDE) Rx Drug: FDA Link

Adverse Drug Reactions for ALFUZOSIN HYDROCHLORIDE* (Alfuzosin 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 ALFUZOSIN HYDROCHLORIDE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dizziness*285
2Fall235
3Dyspnoea234
4Hypotension220
5Drug ineffective*216
6Drug interaction205
7Asthenia185
8Fatigue184
9Diarrhoea180
10Nausea161
11Syncope*158
12Malaise154
13Pyrexia154
14Confusional state153
15Renal failure acute143
16Headache*141
17Anaemia141
18Thrombocytopenia138
19Oedema peripheral136
20Urinary retention130

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

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

Reason # of FDA Reports
1Product used for unknown indication2694
2Benign prostatic hyperplasia*2276
3Prostatic disorder467
4Prostatomegaly322
5Prostatic adenoma240
6Urinary retention224
7Dysuria221
8Micturition disorder158
9Urinary tract disorder143
10Urine flow decreased126

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


Types of Adverse Events for ALFUZOSIN HYDROCHLORIDE

Total Reports Filed with FDA: 21300


Number of FDA Adverse Event Reports by Patient Age for ALFUZOSIN HYDROCHLORIDE

Total Reports Filed with FDA: 21300*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Alfuzosin hydrochloride (Benestan, Alfuzosin, Alfuzosina, Xatral, Alfusozine, Xatral sr, Alfetim, Urion, Uroxatral)

Charts are based on 21300 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.

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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.