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PROPECIA

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Propecia Adverse Events Reported to the FDA Over Time

How are Propecia adverse event reports trending over time?

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

Most Common Propecia Adverse Events Reported to the FDA

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

Erectile Dysfunction
493 (6.5%)
Anxiety
334 (4.4%)
Depression
308 (4.06%)
Libido Decreased
306 (4.03%)
Sexual Dysfunction
274 (3.61%)
Cognitive Disorder
184 (2.42%)
Loss Of Libido
143 (1.88%)
Ejaculation Failure
139 (1.83%)
Ejaculation Disorder
135 (1.78%)
Emotional Distress
117 (1.54%)
Fatigue
97 (1.28%)
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Testicular Pain
91 (1.2%)
Drug Exposure During Pregnancy
76 (1%)
Semen Volume Decreased
71 (.94%)
Hepatic Function Abnormal
70 (.92%)
Disturbance In Attention
63 (.83%)
Penis Disorder
63 (.83%)
Wrong Technique In Drug Usage Proce...
57 (.75%)
Insomnia
54 (.71%)
Blood Testosterone Decreased
51 (.67%)
Panic Attack
51 (.67%)
Alopecia
48 (.63%)
Memory Impairment
47 (.62%)
Dizziness
45 (.59%)
Suicidal Ideation
45 (.59%)
Gynaecomastia
42 (.55%)
Prostate Cancer
42 (.55%)
Feeling Abnormal
39 (.51%)
Genital Hypoaesthesia
39 (.51%)
Testicular Atrophy
39 (.51%)
Mental Disorder
38 (.5%)
Amnesia
37 (.49%)
Headache
37 (.49%)
Muscle Atrophy
37 (.49%)
Intentional Drug Misuse
34 (.45%)
Abortion Spontaneous
33 (.43%)
Asthenia
33 (.43%)
Liver Disorder
33 (.43%)
Palpitations
31 (.41%)
Testicular Disorder
31 (.41%)
Anhedonia
29 (.38%)
Pain
29 (.38%)
Penile Size Reduced
29 (.38%)
Organic Erectile Dysfunction
28 (.37%)
Chest Pain
25 (.33%)
Emotional Disorder
24 (.32%)
Malaise
24 (.32%)
Abdominal Pain
23 (.3%)
Groin Pain
23 (.3%)
Hypoaesthesia
23 (.3%)
Arthralgia
22 (.29%)
Depressed Mood
22 (.29%)
Drug Ineffective
22 (.29%)
Paternal Drugs Affecting Foetus
22 (.29%)
Apathy
21 (.28%)
Swelling Face
21 (.28%)
Tinnitus
21 (.28%)
Urticaria
21 (.28%)
Convulsion
20 (.26%)
Dysuria
20 (.26%)
Male Sexual Dysfunction
20 (.26%)
Sleep Disorder
20 (.26%)
Mental Impairment
19 (.25%)
Mood Swings
19 (.25%)
Muscle Twitching
19 (.25%)
Myalgia
19 (.25%)
Rash
19 (.25%)
Stress
19 (.25%)
Abortion Induced
18 (.24%)
Aspartate Aminotransferase Increase...
18 (.24%)
Alanine Aminotransferase Increased
17 (.22%)
Back Pain
17 (.22%)
Drug Administration Error
17 (.22%)
Hypothyroidism
17 (.22%)
Orgasmic Sensation Decreased
16 (.21%)
Pruritus
16 (.21%)
Pyrexia
16 (.21%)
Testis Cancer
16 (.21%)
Androgen Deficiency
15 (.2%)
Anorgasmia
15 (.2%)
Inappropriate Schedule Of Drug Admi...
15 (.2%)
Semen Analysis Abnormal
15 (.2%)
Somnolence
15 (.2%)
Speech Disorder
15 (.2%)
Affective Disorder
14 (.18%)
Blood Bilirubin Increased
14 (.18%)
Cardiac Disorder
14 (.18%)
Dry Skin
14 (.18%)
Hormone Level Abnormal
14 (.18%)
Myocardial Infarction
14 (.18%)
Orgasm Abnormal
14 (.18%)
Osteonecrosis
14 (.18%)
Prostatitis
14 (.18%)
Skin Disorder
14 (.18%)
Vision Blurred
14 (.18%)
Weight Increased
14 (.18%)
Bronchitis
13 (.17%)
Hair Colour Changes
13 (.17%)
Hypogonadism
13 (.17%)
Paraesthesia
13 (.17%)
Adverse Event
12 (.16%)

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

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

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

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

Alopecia
844
Androgenetic Alopecia
389
Male Pattern Baldness
235
Product Used For Unknown Indication
26
Drug Use For Unknown Indication
20
Prophylaxis
16
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Hair Transplant
10
Hair Growth Abnormal
4
Hair Disorder
4
Hirsutism
3
Drug Exposure During Pregnancy
3
Benign Prostatic Hyperplasia
2
Prostatomegaly
2
Alopecia Areata
2
Hypotrichosis
1
Hypertension
1
Anxiety
1
Headache
1
Trichorrhexis
1
Hypersensitivity
1
Haematospermia
1
Blood Urine Present
1
Skin Disorder
1
Supplementation Therapy
1
Cognitive Disorder
1
Urticaria
1

Drug Labels

LabelLabelerEffective
PropeciaMerck Sharp & Dohme Corp.11-APR-12
PropeciaMerck Sharp & Dohme Corp.11-APR-12
PropeciaBryant Ranch Prepack17-JAN-13

Propecia Case Reports

What Propecia 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 Propecia. 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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