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Proscar (Finasteride) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Proscar (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 (184)
Death (8)
Life Threatening Events (12)
Disability (86)

Reports by Reaction Type

Anxiety (61)Intentional Drug Misuse (53)Depression (48)Wrong Technique in Drug Usage Process (43)Erectile Dysfunction (43)Libido Decreased (40)Sexual Dysfunction (38)Fatigue (33)Asthenia (33)Back Pain (24)Emotional Distress (21)Semen Volume Decreased (21)

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

Possible Proscar side effects in

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

Patient:

Reactions: Arthralgia

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

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

Patient:

Reactions: Prostate Cancer, Sexual Dysfunction, Cognitive Disorder

Drug(s) suspected as cause:
Proscar



Possible Proscar 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 Proscar side effects in

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

Patient:

Reactions: Breast Enlargement, Breast Tenderness, Breast Mass

Drug(s) suspected as cause:
Proscar

Other drugs received by patient: Hyzaar; Viagra; Trazodone HCL; Toprol-XL; Vytorin



Possible Proscar side effects in

Reported by a pharmacist from United States on 2012-08-22

Patient:

Reactions: Gynaecomastia

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in 40 year old male

Reported by a physician from Israel on 2012-08-22

Patient: 40 year old male

Reactions: Atrial Fibrillation, Hyperthyroidism

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation

Proscar



Possible Proscar side effects in 41 year old male

Reported by a physician from United States on 2012-08-17

Patient: 41 year old male, weighing 76.7 kg (168.6 pounds)

Reactions: NO Adverse Event

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: male, weighing 88.5 kg (194.6 pounds)

Reactions: Sexual Dysfunction, Nervous System Disorder, Ill-Defined Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Ejaculation Failure

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-10

Patient: male

Reactions: Breast Cancer Male, Gynaecomastia

Drug(s) suspected as cause:
Avodart
    Dosage: .5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2010-04-15
    End date: 2011-10-15

Proscar
    Dosage: 5mg per day
    Administration route: Oral
    Indication: Benign Prostatic Hyperplasia
    Start date: 2007-06-01
    End date: 2011-06-10

Other drugs received by patient: Tadenan; Glucosamine; Oxazepam; Chondrosulf; Mirtazapine; Zolpidem Tartrate



Possible Proscar side effects in 40 year old male

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

Patient: 40 year old male

Reactions: Atrial Fibrillation, Hyperthyroidism

Drug(s) suspected as cause:
Multaq
    Administration route: Oral
    Indication: Atrial Fibrillation

Proscar



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-07

Patient:

Reactions: Contusion, Alcohol Abuse, Upper-Airway Cough Syndrome, Fear, Headache, Intentional Drug Misuse, Erectile Dysfunction, Suicidal Ideation, Fatigue, Herpes Simplex, Premature Ejaculation, Blood Testosterone Decreased, Blood Cholesterol Increased, Enterocolitis, Gastrooesophageal Reflux Disease, Blood Alcohol Increased, Vomiting, Viral Infection, Functional Gastrointestinal Disorder, Partner Stress, Libido Decreased, Axillary Mass, Anxiety, Hyperlipidaemia, Burns Second Degree, Rhinitis Allergic, Panic Attack, Sleep Disorder, Diarrhoea, Sexual Dysfunction, Hypothyroidism, Hypertension

Drug(s) suspected as cause:
Propecia
    Indication: Alopecia

Propecia
    Dosage: 1 mg, unk
    Administration route: Oral
    Indication: Androgenetic Alopecia

Proscar
    Dosage: 5 mg, unk
    Administration route: Oral
    Indication: Alopecia
    Start date: 2005-09-01



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Apathy, Ejaculation Failure, Erectile Dysfunction, Depressed Mood

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient:

Reactions: Back Pain, Vomiting, Dyspnoea, Nausea, Drug Hypersensitivity, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Insomnia, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Coreg

Glucophage

Ibuprofen (Advil)

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride

Metoprolol Tartrate

Motrin

Plavix

Proscar

Prozac

Reglan

Restasis

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia

Zocor

Other drugs received by patient: Allopurinol; Omega-3-Acid Ethyl Esters; Pilocarpine; Istalol; Clozapine; Bilberry; Oxycodone HCL; Aspirin; Potassium Chloride; Lumigan; Pravastatin Sodium; Furosemide; Vicodin; Losartan Potassium; Digoxin; Folic Acid; Theratears; Diazepam; Lantus



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01

Patient:

Reactions: Back Pain, Dyspnoea, HIP Arthroplasty, Vomiting, Nausea, Abasia, Drug Hypersensitivity, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alprazolam

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)
    Dosage: 200 mg, prn

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride
    Dosage: 500 mg, unk

Metoprolol Tartrate
    Dosage: 25 mg, bid

Motrin

Plavix

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Folic Acid; Pilocarpine; Timolol Maleate; Lantus; Lumigan; Pravastatin Sodium; Thera Tears; Potassium Chloride - USP; Vicodin; Digoxin; Aspirin; Diazepam; Furosemide; Cozaar; Bilberry; Oxycodone HCL; Aspirin; Omega-3 Marine Triglycerides; Clozapine; Allopurinol



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Back Pain, Vomiting, Dyspnoea, HIP Arthroplasty, Nausea, Abasia, Drug Hypersensitivity, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alprazolam

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)
    Dosage: unk, prn

Lipitor

Lotrimin

Luvox

Metformin Hydrochloride

Metoprolol Tartrate
    Dosage: unk, qd

Motrin

Motrin
    Dosage: unk, prn

Plavix

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Xalatan

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Timolol Maleate; Thera Tears; Clozapine; Omega-3 Marine Triglycerides; Aspirin; Losartan Potassium; Allopurinol; Lantus; Potassium Chloride; Pravastatin Sodium; Digoxin; Diazepam; Bilberry; Lumigan; Folic Acid; Furosemide; Oxycodone HCL; Pilocarpine; Acetaminophen / Hydrocodone Bitartrate



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-07-31

Patient:

Reactions: Scrotal Pain

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Back Pain, Dyspnoea, Vomiting, Nausea, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Alprazolam

Clozapine

Codeine

Coreg

Cyclosporine

Glucophage

Ibuprofen (Advil)

Lipitor

Lotrimin AF

Lumigan

Luvox

Metformin Hydrochloride
    Dosage: 500 mg, unk

Metoprolol Tartrate
    Dosage: 25 mg, bid
    Administration route: Oral

Motrin

Oxycodone HCL

Plavix

Pravastatin Sodium

Proscar
    Administration route: Oral

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Viagra

Vicodin

Xalatan
    Dosage: 200 mg, prn

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Losartan Potassium; Thera Tears; Folic Acid; Digoxin; Bilberry; Omega-3 Marine Triglycerides; Pilocarpine; Furosemide; Diazepam; Istalol; Lantus; Allopurinol; Potassium Chloride; Aspirin



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-31

Patient:

Reactions: Back Pain, Chest Discomfort, Dyspnoea, Vomiting, Nausea, Abasia, Drug Hypersensitivity, Constipation, Myalgia, Arthropathy, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Alprazolam

Coreg

Cyclosporine

Ibuprofen (Advil)

Lipitor

Lotrimin AF

Luvox

Metformin Hydrochloride

Plavix

Proscar

Prozac

Reglan

Toprol-XL

Tramadol Hydrochloride

Xalatan

Zetia
    Administration route: Oral

Zocor
    Administration route: Oral

Other drugs received by patient: Omega-3 Marine Triglycerides; Clozapine; Artificial Tears (Hypromellose); Diazepam; Pilocarpine; Lantus; Vicodin; Oxycodone HCL; Lumigan; Furosemide; Digoxin; Aspirin; Bilberry; Timolol Maleate; Allopurinol; Losartan Potassium; Pravastatin Sodium; Potassium Chloride; Folic Acid



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Abdominal Pain, Pain in Extremity, Pain, Necrosis, Muscular Weakness, Drug Interaction, Tricuspid Valve Incompetence, Renal Failure Chronic, Haemodialysis, Myopathy, Paraesthesia, Ileus, Iron Deficiency Anaemia, Mitral Valve Incompetence, Abdominal Distension, Gait Disturbance, Erosive Duodenitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine Besylate
    Dosage: 10 mg, qd
    Administration route: Oral

Doxazosin Mesylate
    Dosage: 8 mg, qd
    Administration route: Oral

Gemfibrozil
    Dosage: 600 mg, unk
    Administration route: Oral

Proscar
    Dosage: 5 mg, qd
    Administration route: Oral

Zocor
    Dosage: 20 mg, qd
    Administration route: Oral

Other drugs received by patient: Ferrous Sulfate TAB; Sodium Polystyrene Sulfonate; Hydralazine HCL; Metoprolol Tartrate; Aspirin; Lantus; Lactulose; Travoprost; Levothyroxine Sodium; Lisinopril; Ergocalciferol; Furosemide



Possible Proscar side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30

Patient:

Reactions: Respiratory Rate Increased, Rhabdomyolysis, Blood Pressure Systolic Increased, Myopathy, Anxiety, Renal Impairment, Ileus, Iron Deficiency Anaemia, Gait Disturbance, Erosive Duodenitis, Tearfulness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amlodipine
    Dosage: 10 mg, unk

Aspirin
    Dosage: 81 mg, unk

Doxazosin Mesylate
    Dosage: 8 mg, unk

Ergocalciferol
    Dosage: 50000 unk, two times a day

Ferrous Sulfate TAB
    Dosage: 325 mg, unk

Furosemide
    Dosage: 40 mg, unk

Gemfibrozil
    Dosage: 600 mg, bid

Hydralazine HCL
    Dosage: 100 mg in divided doses

Lactulose
    Dosage: 20 g, prn

Lantus
    Dosage: 70 u, unk

Levothyroxine Sodium
    Dosage: 88 microgram, unk

Meperidine Hydrochloride

Metoprolol Tartrate
    Dosage: 200 mg, unk

Midazolam

Prinivil
    Dosage: 20 mg, unk

Proscar
    Dosage: 5 mg, unk
    Administration route: Oral

Sodium Polystyrene Sulfonate
    Dosage: 30 g, unk

Travoprost

Zocor
    Dosage: 20 mg, qd, for 1.5 years
    Administration route: Oral

Zocor
    Dosage: 40mg, daily for 9 months



Possible Proscar side effects in

Reported by a consumer/non-health professional from United Kingdom on 2012-07-30

Patient:

Reactions: Pain in Extremity, Chest Pain, Disturbance in Attention, Asthenia, Loss of Libido

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

Reported by a lawyer from United States on 2012-07-27

Patient:

Reactions: Wrong Technique in Drug Usage Process, Prostatitis, Penile Pain, Chest Wall Mass, Nocturia, Intentional Drug Misuse, Pelvic Pain, Erectile Dysfunction, Groin Pain, Suicidal Ideation, Colonic Polyp, Muscle Strain, Scrotal Pain, Palpitations, Anger, Depression, Mood Swings, Open Wound, Loss of Libido, Epistaxis, Ventricular Extrasystoles, Epididymal Cyst, Joint Dislocation, Lumbar Vertebral Fracture, Cognitive Disorder, Joint Injury, Antisocial Behaviour, Anxiety, Diverticulum, Genital Hypoaesthesia, Testicular Pain

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Propecia
    Dosage: 1 mg, unk
    Administration route: Oral
    Indication: Alopecia
    Start date: 2004-11-01
    End date: 2009-07-20

Proscar
    Dosage: unk mg, unk
    Administration route: Oral
    Indication: Alopecia
    Start date: 2004-11-01
    End date: 2006-06-19

Proscar
    Dosage: unk mg, unk
    Administration route: Oral
    Start date: 2006-09-23
    End date: 2009-07-20



Possible Proscar side effects in

Reported by a lawyer from United States on 2012-07-23

Patient:

Reactions: Abdominal Pain, Genitourinary Tract Neoplasm, Wheezing, Intentional Drug Misuse, Nocturia, Erectile Dysfunction, Phimosis, Overdose, DRY Mouth, Anorgasmia, Depression, Back Pain, Dyspnoea, Dysphagia, 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
    Start date: 2010-01-01
    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



Possible Proscar side effects in

Reported by a consumer/non-health professional from Ireland on 2012-07-23

Patient:

Reactions: Off Label Use, Overdose, Pancreatitis Chronic, Type 1 Diabetes Mellitus

Drug(s) suspected as cause:
Proscar

Other drugs received by patient: Insulin



Possible Proscar side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-23

Patient: male, weighing 73.5 kg (161.7 pounds)

Reactions: Peyronie's Disease, Libido Decreased, Sexual Dysfunction, Ejaculation Delayed

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Proscar



Possible Proscar side effects in

Reported by a consumer/non-health professional from China on 2012-07-18

Patient:

Reactions: Haemorrhage Intracranial, Dizziness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Proscar

Other drugs received by patient: Terazosin HCL



Possible Proscar side effects in

Reported by a consumer/non-health professional from United States on 2012-07-16

Patient:

Reactions: Breast Enlargement

Drug(s) suspected as cause:
Proscar

Other drugs received by patient: Lipitor



Possible Proscar side effects in 70 year old male

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: 70 year old male, weighing 106.5 kg (234.3 pounds)

Reactions: Back Pain, HIP Arthroplasty, Vomiting, Dyspnoea, Nausea, Abasia, Constipation, Skin Irritation, Myalgia, Fatigue, Sleep Disorder, Asthenia, Blood Glucose Increased

Adverse event resulted in: hospitalization, disablity

Drug(s) suspected as cause:
Alprazolam
    Indication: Product Used FOR Unknown Indication

Codeine Sulfate
    Indication: Product Used FOR Unknown Indication

Coreg
    Indication: Cardiac Disorder

Cyclosporine
    Indication: Product Used FOR Unknown Indication

Glucophage
    Indication: Product Used FOR Unknown Indication

Ibuprofen
    Dosage: (200 mg , as required),
    Indication: Back Pain
    Start date: 2002-01-01
    End date: 2011-01-01

Lipitor
    Indication: Product Used FOR Unknown Indication

Lotrimin
    Indication: Product Used FOR Unknown Indication

Luvox
    Indication: Product Used FOR Unknown Indication

Metformin Hydrochloride
    Dosage: (500 mg),
    Indication: Diabetes Mellitus
    Start date: 2010-10-18

Metoprolol Tartrate
    Dosage: 50 mg (25 mg, 2 in 1 d),oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2009-01-01

Motrin
    Indication: Product Used FOR Unknown Indication

Plavix
    Indication: Product Used FOR Unknown Indication

Proscar
    Indication: Product Used FOR Unknown Indication

Prozac
    Indication: Product Used FOR Unknown Indication

Reglan
    Indication: Product Used FOR Unknown Indication

Toprol-XL
    Indication: Product Used FOR Unknown Indication

Tramadol Hydrochloride
    Indication: Product Used FOR Unknown Indication

Viagra
    Indication: Product Used FOR Unknown Indication

Xalatan
    Dosage: ophthalmic
    Indication: Product Used FOR Unknown Indication

Zetia
    Indication: Product Used FOR Unknown Indication

Zocor
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Losartan Potassium; Istalol(timolol Maleate); Vicodin; Aspirin; Oxycodone HCL; Diazepam; Fish Oil(fish Oil); Digoxin; Pilocarpine; Potassium Chloride; Thera Tears(carmellose); Allopurinol; Lantus; Bilberry(vaccinium Myrtillus); Clozapine; Pravastatin; Furosemide(furosemide); Folic Acid



Possible Proscar side effects in 64 year old male

Reported by a consumer/non-health professional from United States on 2012-07-02

Patient: 64 year old male, weighing 81.6 kg (179.6 pounds)

Reactions: Loss of Libido, Erectile Dysfunction

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Proscar

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