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Propecia (Finasteride) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Propecia (Finasteride) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (582)
Death (4)
Life Threatening Events (7)
Disability (290)

Reports by Reaction Type

Erectile Dysfunction (310)Anxiety (260)Sexual Dysfunction (247)Depression (231)Libido Decreased (228)Cognitive Disorder (167)Ejaculation Failure (124)Ejaculation Disorder (123)Loss of Libido (81)Emotional Distress (71)Fatigue (60)Semen Volume Decreased (55)

Below are a few examples of reports where side effects / adverse reactions may be related to Propecia (Finasteride). For a complete list or a specific selection of reports, please use the links above.

Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-24

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-24

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Wrong Technique in Drug Usage Process, Fear, Alopecia, Musculoskeletal Stiffness, Libido Decreased, Hair Disorder

Drug(s) suspected as cause:
Propecia
    Dosage: unk unk, qd
    Administration route: Oral
    Start date: 1998-06-01

Propecia
    Dosage: 0.5 mg, qd
    Administration route: Oral

Propecia
    Dosage: unk, qid
    Start date: 2011-07-01

Propecia
    Dosage: unk unk, qd
    Administration route: Oral
    End date: 2012-06-26

Other drugs received by patient: Flonase



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-24

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Muscle Atrophy, Orgasmic Sensation Decreased, Erectile Dysfunction, Poor Quality Sleep, Speech Disorder, Anhedonia, Fatigue, Blunted Affect, Hair Growth Abnormal, Adverse Event, Depression, Loss of Libido, Testicular Disorder, Ejaculation Failure, Semen Discolouration, Body Temperature Decreased, Varicose Vein, Muscle Twitching, Mental Impairment, Panic Attack, Blood Prolactin Increased, Semen Volume Decreased, Insomnia, Testicular Pain, Sexual Dysfunction, Penis Disorder, Memory Impairment, Depressed Mood, Hair Colour Changes

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Propecia
    Dosage: unk
    Administration route: Oral
    Start date: 2005-01-01

Propecia
    Dosage: 1 mg, qd
    Administration route: Oral
    Start date: 2011-05-26
    End date: 2011-10-28



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Sexual Dysfunction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from Israel on 2012-08-24

Patient:

Reactions: Rhabdomyolysis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Anxiety, Sexual Dysfunction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Musculoskeletal Stiffness, Muscle Spasms

Drug(s) suspected as cause:
Propecia

Other drugs received by patient: Abilify



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Weight Decreased, Muscle Atrophy, Pain, Penile Size Reduced, Erectile Dysfunction, Erythema, Hot Flush, Depression, Loss of Libido, Prostatic Pain, Penile Curvature, Amnesia, Paraesthesia, Genital Hypoaesthesia, Panic Attack, Arthralgia, Insomnia, Disturbance in Attention, Testicular Pain, Penis Disorder, FAT Tissue Increased

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Abdominal Pain, Diarrhoea, DRY Eye, Erectile Dysfunction, Amnesia

Drug(s) suspected as cause:
Propecia

Other drugs received by patient: Vitamin D



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Ejaculation Failure, Libido Decreased, Cognitive Disorder, Erectile Dysfunction, Ejaculation Disorder, Anxiety, Sexual Dysfunction, Depression

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Anxiety, Sleep Disorder, Depression, Erectile Dysfunction

Drug(s) suspected as cause:
Propecia

Other drugs received by patient: Lipitor



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Abdominal Pain, Genitourinary Tract Neoplasm, Wheezing, Intentional Drug Misuse, Nocturia, Erectile Dysfunction, Overdose, Phimosis, DRY Mouth, Anorgasmia, Depression, Back Pain, Dysphagia, Dyspnoea, Poor Dental Condition, Male Genital Examination Abnormal, Rhinitis, Androgen Deficiency, Emotional Distress, Anxiety, Prostatic Specific Antigen Increased, Prostatomegaly, Penis Disorder, Vertigo Positional, Inguinal Hernia

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Alopecia
    Start date: 2007-01-01
    End date: 2010-11-01

Proscar
    Dosage: 5 mg, qd
    Administration route: Oral
    Indication: Alopecia
    Start date: 2007-01-01
    End date: 2010-11-01

Proscar
    Dosage: 5 mg, qd
    Administration route: Oral
    Start date: 2010-01-01
    End date: 2010-11-01



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Erectile Dysfunction

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23

Patient:

Reactions: Hirsutism

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Peyronie's Disease, Libido Decreased

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a physician from United States on 2012-08-23

Patient:

Reactions: Anxiety, Emotional Distress, Sexual Dysfunction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Erectile Dysfunction, Prostatic Disorder, Ejaculation Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a consumer/non-health professional from Japan on 2012-08-23

Patient:

Reactions: Weight Decreased, Liver Disorder

Drug(s) suspected as cause:
Propecia

Other drugs received by patient: Turmeric



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia



Possible Propecia side effects in

Reported by a lawyer from United States on 2012-08-23

Patient:

Reactions: Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Propecia

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