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ALFUZOSIN

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Alfuzosin Adverse Events Reported to the FDA Over Time

How are Alfuzosin adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Alfuzosin, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Alfuzosin is flagged as the suspect drug causing the adverse event.

Most Common Alfuzosin Adverse Events Reported to the FDA

What are the most common Alfuzosin adverse events reported to the FDA?

Dizziness
176 (4.06%)
Syncope
82 (1.89%)
Hypotension
76 (1.75%)
Headache
65 (1.5%)
Drug Ineffective
63 (1.45%)
Fall
63 (1.45%)
Loss Of Consciousness
59 (1.36%)
Fatigue
56 (1.29%)
Malaise
56 (1.29%)
Dyspnoea
53 (1.22%)
Nausea
53 (1.22%)
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Diarrhoea
51 (1.18%)
Feeling Abnormal
51 (1.18%)
Oedema Peripheral
51 (1.18%)
Insomnia
47 (1.08%)
Blood Pressure Decreased
42 (.97%)
Drug Interaction
41 (.95%)
Atrial Fibrillation
37 (.85%)
Urinary Retention
37 (.85%)
Hypertension
35 (.81%)
Dysuria
33 (.76%)
Orthostatic Hypotension
33 (.76%)
Asthenia
32 (.74%)
Back Pain
29 (.67%)
Confusional State
29 (.67%)
Pollakiuria
28 (.65%)
Vomiting
28 (.65%)
Cold Sweat
27 (.62%)
Nocturia
26 (.6%)
Somnolence
25 (.58%)
Tremor
22 (.51%)
Haemorrhagic Stroke
21 (.48%)
Muscle Spasms
21 (.48%)
Pruritus
21 (.48%)
Urine Flow Decreased
21 (.48%)
Abdominal Discomfort
20 (.46%)
Erythema
20 (.46%)
Vision Blurred
20 (.46%)
Blood Glucose Increased
19 (.44%)
Cerebrovascular Accident
19 (.44%)
Constipation
19 (.44%)
Anxiety
18 (.42%)
Chest Pain
18 (.42%)
Pain In Extremity
18 (.42%)
Renal Failure Acute
18 (.42%)
Abdominal Pain
17 (.39%)
Arthralgia
17 (.39%)
Gait Disturbance
17 (.39%)
Heart Rate Increased
17 (.39%)
Abdominal Pain Upper
16 (.37%)
Eye Irritation
16 (.37%)
Hyperhidrosis
16 (.37%)
Nasal Congestion
16 (.37%)
Prostate Cancer
16 (.37%)
Condition Aggravated
15 (.35%)
Coordination Abnormal
15 (.35%)
Cytolytic Hepatitis
15 (.35%)
Erectile Dysfunction
15 (.35%)
Musculoskeletal Stiffness
15 (.35%)
Pyrexia
15 (.35%)
Renal Failure
15 (.35%)
Road Traffic Accident
15 (.35%)
Cerebral Haemorrhage
14 (.32%)
Cholestasis
14 (.32%)
Depressed Level Of Consciousness
14 (.32%)
Middle Insomnia
14 (.32%)
Sexual Dysfunction
14 (.32%)
Brain Death
13 (.3%)
Cough
13 (.3%)
Dehydration
13 (.3%)
Depression
13 (.3%)
Dysphagia
13 (.3%)
Myalgia
13 (.3%)
Neck Pain
13 (.3%)
Palpitations
13 (.3%)
Pneumonia
13 (.3%)
Rash
13 (.3%)
Respiratory Arrest
13 (.3%)
Toxic Epidermal Necrolysis
13 (.3%)
Blood Pressure Increased
12 (.28%)
Circulatory Collapse
12 (.28%)
Coagulopathy
12 (.28%)
Drug Effect Decreased
12 (.28%)
Hypersensitivity
12 (.28%)
Hyporeflexia
12 (.28%)
Influenza Like Illness
12 (.28%)
Stevens-johnson Syndrome
12 (.28%)
Stool Analysis Abnormal
12 (.28%)
Abnormal Behaviour
11 (.25%)
Aspartate Aminotransferase Increase...
11 (.25%)
Dry Mouth
11 (.25%)
Jaundice
11 (.25%)
Micturition Urgency
11 (.25%)
Muscular Weakness
11 (.25%)
Neutropenia
11 (.25%)
Prostatic Specific Antigen Increase...
11 (.25%)
Aneurysm
10 (.23%)
Apnoea
10 (.23%)
Balance Disorder
10 (.23%)
Bladder Discomfort
10 (.23%)
Coma
10 (.23%)

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This graph shows the top adverse events submitted to the FDA for Alfuzosin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alfuzosin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Alfuzosin

What are the most common Alfuzosin adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Alfuzosin, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Alfuzosin is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Alfuzosin According to Those Reporting Adverse Events

Why are people taking Alfuzosin, according to those reporting adverse events to the FDA?

Benign Prostatic Hyperplasia
555
Drug Use For Unknown Indication
139
Product Used For Unknown Indication
130
Prostatic Disorder
112
Urinary Retention
62
Prostatomegaly
59
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Dysuria
45
Micturition Disorder
35
Pollakiuria
35
Prostatic Adenoma
30
Prostate Examination Abnormal
25
Prostatism
23
Nocturia
23
Urinary Tract Disorder
23
Ill-defined Disorder
18
Bladder Disorder
18
Urine Flow Decreased
18
Urinary Incontinence
12
Prostatitis
12
Hypertonic Bladder
11
Prostate Cancer
8
Bladder Obstruction
7
Urine Abnormality
5
Hypertension
5
Renal Colic
4
Residual Urine Volume
3
Depression
3
Multiple Sclerosis
3
Brachytherapy To Prostate
3
Urinary Tract Infection
3
Benign Neoplasm Of Prostate
3
Urinary Tract Obstruction
2
Micturition Urgency
2
Sexual Dysfunction
2
Prostatic Specific Antigen Increase...
2
Muscle Disorder
2
Prostatic Obstruction
2
Incontinence
2
Cardiac Disorder
2
Lower Urinary Tract Symptoms
2
Cystitis
2
Erectile Dysfunction
2
Bladder Dysfunction
2
Hypotonic Urinary Bladder
2
Dementia
2
Disease Recurrence
1
Nephrolithiasis
1
Drug Level
1
Renal Disorder
1
Discomfort
1
Prostatic Pain
1

Drug Labels

LabelLabelerEffective
UroxatralStat Rx USA27-OCT-09
Alfuzosin HydrochlorideApotex Corp.09-JUN-11
Alfuzosin HydrochlorideSun Pharma Global FZE24-NOV-11
Alfuzosin HydrochlorideMylan Pharmaceuticals Inc.08-DEC-11
Alfuzosin HydrochlorideGolden State Medical Supply, Inc.09-JAN-12
Alfuzosin Hydrochlorideextended ReleaseCamber Pharmaceuticals18-JAN-12
Alfuzosin HydrochlorideTorrent Pharmaceuticals Limited29-FEB-12
Alfuzosin Hydrochloride ErAvKARE, Inc.13-MAR-12
Alfuzosin HydrochloridePhysicians Total Care, Inc.05-APR-12
Alfuzosin HydrochlorideWockhardt USA LLC.20-JUL-12
Alfuzosin HydrochlorideWockhardt Limited20-JUL-12
Uroxatralsanofi-aventis U.S. LLC01-AUG-12
UroxatralPhysicians Total Care, Inc.30-AUG-12
Alfuzosin Hydrochloride Aurobindo Pharma Limited03-SEP-12
Alfuzosin Hydrochloride Exelan Pharmaceuticals Inc.02-OCT-12
Alfuzosin HydrochlorideMylan Pharmaceuticals Inc.07-MAY-13

Alfuzosin Case Reports

What Alfuzosin safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Alfuzosin. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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