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Proscar Adverse Events Reported to the FDA Over Time

How are Proscar adverse event reports trending over time?

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

Most Common Proscar Adverse Events Reported to the FDA

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

Erectile Dysfunction
88 (2.51%)
Wrong Technique In Drug Usage Proce...
64 (1.82%)
Gynaecomastia
62 (1.77%)
Depression
59 (1.68%)
Anxiety
58 (1.65%)
Libido Decreased
53 (1.51%)
Prostate Cancer
51 (1.45%)
Dyspnoea
49 (1.4%)
Fatigue
47 (1.34%)
Asthenia
46 (1.31%)
Drug Exposure During Pregnancy
46 (1.31%)
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Intentional Drug Misuse
42 (1.2%)
Dizziness
32 (.91%)
Myalgia
29 (.83%)
Nausea
28 (.8%)
Back Pain
27 (.77%)
Emotional Distress
27 (.77%)
Vomiting
25 (.71%)
Sexual Dysfunction
24 (.68%)
Testicular Pain
24 (.68%)
Semen Volume Decreased
23 (.66%)
Abasia
21 (.6%)
Penis Disorder
21 (.6%)
Abortion Spontaneous
20 (.57%)
Breast Cancer
20 (.57%)
Pyrexia
20 (.57%)
Drug Ineffective
19 (.54%)
Loss Of Libido
19 (.54%)
Overdose
18 (.51%)
Off Label Use
17 (.48%)
Sleep Disorder
17 (.48%)
Suicidal Ideation
17 (.48%)
Chest Pain
16 (.46%)
Constipation
16 (.46%)
Insomnia
16 (.46%)
Rash
16 (.46%)
Abdominal Pain
15 (.43%)
Blood Glucose Increased
15 (.43%)
Influenza Like Illness
15 (.43%)
Urinary Retention
15 (.43%)
Fall
14 (.4%)
Headache
14 (.4%)
Urticaria
14 (.4%)
Asthma
13 (.37%)
Cognitive Disorder
13 (.37%)
Disturbance In Attention
13 (.37%)
Hypospadias
13 (.37%)
Skin Irritation
13 (.37%)
Thrombocytopenia
13 (.37%)
Diarrhoea
12 (.34%)
Genital Hypoaesthesia
12 (.34%)
Prostatitis
12 (.34%)
Adverse Event
11 (.31%)
Arrhythmia
11 (.31%)
Breast Cancer Male
11 (.31%)
Haematuria
11 (.31%)
Hepatitis
11 (.31%)
Loss Of Consciousness
11 (.31%)
Nipple Pain
11 (.31%)
Nocturia
11 (.31%)
Prostatic Disorder
11 (.31%)
Pruritus
11 (.31%)
Pulmonary Embolism
11 (.31%)
Blood Testosterone Decreased
10 (.29%)
Bone Disorder
10 (.29%)
Breast Pain
10 (.29%)
Cytolytic Hepatitis
10 (.29%)
Drug Hypersensitivity
10 (.29%)
Drug Interaction
10 (.29%)
Drug Rash With Eosinophilia And Sys...
10 (.29%)
Dysuria
10 (.29%)
Ejaculation Disorder
10 (.29%)
Epistaxis
10 (.29%)
Groin Pain
10 (.29%)
Hypotension
10 (.29%)
Oedema Peripheral
10 (.29%)
Rash Maculo-papular
10 (.29%)
Varicella
10 (.29%)
Ventricular Extrasystoles
10 (.29%)
Vision Blurred
10 (.29%)
Alopecia
9 (.26%)
Amnesia
9 (.26%)
Androgen Deficiency
9 (.26%)
Chest Discomfort
9 (.26%)
Coronary Artery Disease
9 (.26%)
Drug Administration Error
9 (.26%)
Dysphagia
9 (.26%)
Muscle Atrophy
9 (.26%)
Palpitations
9 (.26%)
Paternal Drugs Affecting Foetus
9 (.26%)
Urinary Tract Infection
9 (.26%)
Urine Flow Decreased
9 (.26%)
Abortion Induced
8 (.23%)
Anaemia
8 (.23%)
Anger
8 (.23%)
Anorgasmia
8 (.23%)
Cerebrovascular Accident
8 (.23%)
Confusional State
8 (.23%)
Diverticulum
8 (.23%)
Ejaculation Failure
8 (.23%)
Feeling Abnormal
8 (.23%)

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This graph shows the top adverse events submitted to the FDA for Proscar, 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 Proscar 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 Proscar

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

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This graph shows the top categories of adverse events submitted to the FDA for Proscar, 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 Proscar 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 Proscar According to Those Reporting Adverse Events

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

Benign Prostatic Hyperplasia
600
Alopecia
126
Drug Use For Unknown Indication
114
Prostatomegaly
106
Prostatic Disorder
88
Product Used For Unknown Indication
87
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Prostate Cancer
62
Prostatic Adenoma
31
Prostate Examination Abnormal
27
Prostatitis
24
Androgenetic Alopecia
20
Dysuria
15
Prophylaxis
8
Prostatism
8
Urinary Tract Disorder
8
Urinary Retention
5
Atrial Fibrillation
5
Hypertension
5
Prostate Cancer Stage 0
4
Bladder Disorder
4
Nocturia
4
Prostatic Specific Antigen Increase...
4
Drug Exposure During Pregnancy
4
Hirsutism
4
Male Pattern Baldness
4
Polycystic Ovaries
4
Alopecia Areata
4
Ill-defined Disorder
3
Dihydrotestosterone Increased
3
Urinary Incontinence
3
Pollakiuria
3
Micturition Disorder
2
Haematuria
2
Hair Transplant
2
Hidradenitis
2
Urinary Tract Infection
1
Hypotrichosis
1
Prostate Infection
1
Urine Flow Decreased
1
Cardiac Disorder
1
Benign Neoplasm Of Prostate
1
Bladder Obstruction
1
Blood Pressure
1
Prostatectomy
1
Blood Testosterone
1
Neuralgia
1
Micturition Urgency
1
Hair Growth Abnormal
1
Renal Disorder
1
Discomfort
1

Drug Labels

LabelLabelerEffective
ProscarMerck Sharp & Dohme Corp.18-JAN-13

Proscar Case Reports

What Proscar 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 Proscar. 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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