FINASTERIDE

Finasteride Adverse Events Reported to the FDA Over Time

How are Finasteride adverse event reports trending over time?

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

Most Common Finasteride Adverse Events Reported to the FDA

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

Erectile Dysfunction	87 (3.31%)
Depression	64 (2.43%)
Anxiety	51 (1.94%)
Fatigue	50 (1.9%)
Gynaecomastia	48 (1.82%)
Dizziness	38 (1.44%)
Libido Decreased	38 (1.44%)
Loss Of Libido	35 (1.33%)
Loss Of Consciousness	32 (1.22%)
Wrong Technique In Drug Usage Proce...	32 (1.22%)
Disturbance In Attention	29 (1.1%)
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Testicular Pain	27 (1.03%)
Drug Ineffective	26 (.99%)
Asthenia	24 (.91%)
Myalgia	24 (.91%)
Arthralgia	23 (.87%)
Penis Disorder	23 (.87%)
Insomnia	22 (.84%)
Haematuria	21 (.8%)
Ventricular Extrasystoles	21 (.8%)
Hyperthyroidism	20 (.76%)
Sexual Dysfunction	20 (.76%)
Intentional Drug Misuse	19 (.72%)
Aggression	18 (.68%)
Drug Interaction	17 (.65%)
Suicidal Ideation	17 (.65%)
Urine Flow Decreased	17 (.65%)
Product Substitution Issue	16 (.61%)
Blood Testosterone Decreased	15 (.57%)
Dyspnoea	14 (.53%)
Rash	14 (.53%)
Atrioventricular Block First Degree	13 (.49%)
Ejaculation Failure	13 (.49%)
Fall	13 (.49%)
Muscle Spasms	13 (.49%)
Penile Size Reduced	13 (.49%)
Semen Volume Decreased	13 (.49%)
Accidental Exposure	12 (.46%)
Alanine Aminotransferase Increased	12 (.46%)
Amnesia	12 (.46%)
Anhedonia	12 (.46%)
Dysgeusia	12 (.46%)
Muscle Atrophy	12 (.46%)
Palpitations	12 (.46%)
Prostatitis	12 (.46%)
Tremor	12 (.46%)
Apathy	11 (.42%)
Cerebrovascular Accident	11 (.42%)
Drug Dispensing Error	11 (.42%)
Drug Prescribing Error	11 (.42%)
Pain	11 (.42%)
Panic Attack	11 (.42%)
Product Quality Issue	11 (.42%)
Dark Circles Under Eyes	10 (.38%)
Diarrhoea	10 (.38%)
Dysuria	10 (.38%)
Emotional Disorder	10 (.38%)
Hallucination	10 (.38%)
Mental Disorder	10 (.38%)
Self Esteem Decreased	10 (.38%)
Testicular Atrophy	10 (.38%)
Urinary Retention	10 (.38%)
Cognitive Disorder	9 (.34%)
Emotional Distress	9 (.34%)
Flatulence	9 (.34%)
Hyperhidrosis	9 (.34%)
Impaired Work Ability	9 (.34%)
Memory Impairment	9 (.34%)
Mood Swings	9 (.34%)
Oedema Peripheral	9 (.34%)
Prostatic Specific Antigen Increase...	9 (.34%)
Psychiatric Symptom	9 (.34%)
Skin Disorder	9 (.34%)
Wrong Drug Administered	9 (.34%)
Anger	8 (.3%)
Back Pain	8 (.3%)
Blood Glucose Increased	8 (.3%)
Coordination Abnormal	8 (.3%)
Dizziness Postural	8 (.3%)
Dry Skin	8 (.3%)
Feeling Abnormal	8 (.3%)
Floppy Iris Syndrome	8 (.3%)
Homicide	8 (.3%)
Musculoskeletal Pain	8 (.3%)
Organic Erectile Dysfunction	8 (.3%)
Paraesthesia	8 (.3%)
Prostate Cancer	8 (.3%)
Pruritus	8 (.3%)
Rhinorrhoea	8 (.3%)
Testicular Swelling	8 (.3%)
Thrombocytopenia	8 (.3%)
Azoospermia	7 (.27%)
Blood Alkaline Phosphatase Increase...	7 (.27%)
Depressed Mood	7 (.27%)
Gait Disturbance	7 (.27%)
Hormone Level Abnormal	7 (.27%)
Liver Function Test Abnormal	7 (.27%)
Muscle Disorder	7 (.27%)
Nocturia	7 (.27%)
Pain In Extremity	7 (.27%)
Skin Atrophy	7 (.27%)

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

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

Sexual Function And Fertility	153 (5.82%)
Neurological	130 (4.94%)
Depressed Mood Disorders	97 (3.69%)
Medication Errors	96 (3.65%)
Sexual Dysfunctions, Disturbances A...	89 (3.38%)
Epidermal And Dermal Conditions	86 (3.27%)
Urinary Tract Signs	79 (3%)
Muscle	75 (2.85%)
Breast	74 (2.81%)
Anxiety Disorders	70 (2.66%)
Mental Impairment	65 (2.47%)
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Therapeutic And Nontherapeutic Effe...	65 (2.47%)
Testicular And Epididymal	60 (2.28%)
Mood Disorders	52 (1.98%)
Penile And Scrotal Disorders	46 (1.75%)
Cardiac Arrhythmias	44 (1.67%)
Endocrine Investigations	37 (1.41%)
Gastrointestinal Signs	36 (1.37%)
Respiratory	36 (1.37%)
Personality Disorders	34 (1.29%)
Product Quality Issues	34 (1.29%)
Hepatobiliary	33 (1.25%)
Musculoskeletal And Connective Tiss...	32 (1.22%)
Psychiatric	32 (1.22%)
Skin Appendage Conditions	32 (1.22%)
Thyroid Gland	28 (1.06%)
Injuries	27 (1.03%)
Joint	27 (1.03%)
Cardiac And Vascular Investigations	26 (.99%)
Reproductive Organ And Breast Inves...	25 (.95%)
Sleep Disorders	24 (.91%)
Lifestyle Issues	20 (.76%)
Suicidal And Self-injurious Behavio...	19 (.72%)
Gastrointestinal Motility And Defec...	18 (.68%)
Tissue	18 (.68%)
Disturbances In Thinking	17 (.65%)
Infections - Pathogen Unspecified	17 (.65%)
Legal Issues	16 (.61%)
Renal Disorders	16 (.61%)
Immunology And Allergy	15 (.57%)
Reproductive Neoplasms Male Maligna...	15 (.57%)
Metabolic, Nutritional And Blood Ga...	14 (.53%)
Movement Disorders	14 (.53%)
Central Nervous System Vascular	13 (.49%)
Psychiatric And Behavioural Symptom...	13 (.49%)
Reproductive Tract	13 (.49%)
Cardiac Disorder Signs	12 (.46%)
Cardiac Valve	12 (.46%)
Male Reproductive Tract Infections ...	12 (.46%)
Menstrual Cycle And Uterine Bleedin...	12 (.46%)
Procedural And Device Related Injur...	12 (.46%)
Dental And Gingival Conditions	11 (.42%)
Eye	11 (.42%)
Musculoskeletal And Connective Tiss...	11 (.42%)
Physical Examination Topics	11 (.42%)
Pigmentation	11 (.42%)
Vascular	11 (.42%)
Bone And Joint Injuries	10 (.38%)
Anemias Nonhemolytic And Marrow Dep...	9 (.34%)
Enzyme	9 (.34%)
Oral Soft Tissue Conditions	9 (.34%)
Upper Respiratory Tract Disorders	9 (.34%)
Abortions And Stillbirth	8 (.3%)
Anterior Eye Structural Change, Dep...	8 (.3%)
Chemical Injury And Poisoning	8 (.3%)
Decreased And Nonspecific Blood Pre...	8 (.3%)
Hematology Investigations	8 (.3%)
Peripheral Neuropathies	8 (.3%)
Platelet	8 (.3%)
Vision	8 (.3%)
Communication Disorders	7 (.27%)
Cornification And Dystrophic Skin	7 (.27%)
Deliria	7 (.27%)
Fungal Infectious	7 (.27%)
Gastrointestinal Ulceration And Per...	7 (.27%)
Metabolism	7 (.27%)
Therapeutic Procedures And Supporti...	7 (.27%)
Viral Infectious	7 (.27%)
Coagulopathies And Bleeding Diathes...	6 (.23%)
Diverticular	6 (.23%)
Endocrine Disorders Of Gonadal Func...	6 (.23%)
Inner Ear And Viiith Cranial Nerve	6 (.23%)
Ocular Structural Change, Deposit A...	6 (.23%)
Acid-base	5 (.19%)
Breast Neoplasms Malignant And Unsp...	5 (.19%)
Encephalopathies	5 (.19%)
Gastrointestinal Conditions	5 (.19%)
Gastrointestinal Inflammatory Condi...	5 (.19%)
Investigations, Imaging And Histopa...	5 (.19%)
Prostatic Disorders	5 (.19%)
Allergic Conditions	4 (.15%)
Arteriosclerosis, Stenosis, Vascula...	4 (.15%)
Benign Neoplasms Gastrointestinal	4 (.15%)
Cervix Disorders	4 (.15%)
Gastrointestinal Stenosis And Obstr...	4 (.15%)
Headaches	4 (.15%)
Lower Respiratory Tract Disorders	4 (.15%)
Maternal Complications Of Labour An...	4 (.15%)
Pregnancy, Labour, Delivery And Pos...	4 (.15%)
Red Blood Cell	4 (.15%)
Uterine, Pelvic And Broad Ligament	4 (.15%)

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This graph shows the top categories of adverse events submitted to the FDA for Finasteride, 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 Finasteride 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.