FDA Adverse Events Reports (FAERS) Summary for PROPECIA

These tables and charts are based on 5,340 total reports for PROPECIA (FINASTERIDE) received by the FDA Adverse Event Reporting System (FAERS) from 2004 through July 30, 2026.

This FAERS total includes 5,080 pharmaceutical company-submitted and non-U.S. FAERS reports and 260 U.S. consumer or healthcare provider-submitted MedWatch reports. Adverse events listed on this page represent serious and sometimes rare adverse events reported to pharmaceutical companies, and often do not represent typical side effects for the medication. Find common side effects in the most recent official drug label.

For a separate summary of the 260 U.S. reports filed via the FDA MedWatch voluntary reporting system, view our FDA MedWatch PROPECIA summary report. (See notes section below for explanation of FDA’s mandatory and voluntary reporting system.)

Top 20 Adverse Effects Associated with PROPECIA (reported in FAERS Database)

	Side Effect	# of FDA Reports
1	ERECTILE DYSFUNCTION	2118
2	SEXUAL DYSFUNCTION	1743
3	DEPRESSION	1537
4	ANXIETY	1371
5	COGNITIVE DISORDER	1109
6	LIBIDO DECREASED	1023
7	LOSS OF LIBIDO	742
8	FATIGUE	639
9	EJACULATION DISORDER	508
10	INSOMNIA	463
11	EJACULATION FAILURE	371
12	SEMEN VOLUME DECREASED	354
13	TESTICULAR PAIN	350
14	SUICIDAL IDEATION	342
15	DRUG INEFFECTIVE	331
16	HAIR LOSS	308
17	BLOOD TESTOSTERONE DECREASED	305
18	HEADACHE	296
19	BREAST ENLARGEMENT MALE	282
20	FEELING ABNORMAL	281
21	HIGH BLOOD PRESSURE	268
22	DISTURBANCE IN ATTENTION	265
23	HYPOGONADISM	265
24	LACK OF STRENGTH AND ENERGY (ASTHENIA)	253
25	PANIC ATTACK	225
26	DIZZINESS	221
27	BACK PAIN	219
28	JOINT PAIN	217
29	DRUG ADMINISTRATION ERROR	205
30	PENILE SIZE REDUCED	192
31	GASTROOESOPHAGEAL REFLUX DISEASE	183
32	MEMORY IMPAIRMENT	181
33	WEIGHT INCREASED	177
34	PAIN	174
35	PENIS DISORDER	171
36	ADVERSE EVENT	169
37	STRESS	163
38	MUSCLE ATROPHY	160
39	EMOTIONAL DISTRESS	159
40	HORMONE LEVEL ABNORMAL	158
41	AMNESIA	157
42	BENIGN PROSTATIC HYPERPLASIA	154
43	ORGANIC ERECTILE DYSFUNCTION	151
44	HYPERLIPIDAEMIA	150
45	SLEEP DISORDER	146
46	NUMBNESS	139
47	PALPITATIONS	139
48	TESTICULAR ATROPHY	139
49	SHORTNESS OF BREATH	137
50	CHEST PAIN	135
51	URINATION DIFFICULTY	131
52	BRAIN INJURY	128
53	SLEEP APNEA	127
54	VISION BLURRED	127
55	NAUSEA	126
56	MUSCLE PAIN	125
57	MENTAL DISORDER	123
58	PROSTATITIS	122
59	GENITAL HYPOAESTHESIA	121
60	TESTICULAR DISORDER	120
61	MALAISE	119
62	WEIGHT DECREASED	119
63	WRONG TECHNIQUE IN PRODUCT USAGE PROCESS	119
64	RINGING IN THE EARS	115
65	DRY SKIN	112
66	RASH	112
67	LOSS OF ALL PLEASURE	109
68	PEYRONIE^S DISEASE	109
69	PAINFUL URINATION	108
70	ITCHING	108
71	PAIN IN EXTREMITY	107
72	PENIS INJURY	102
73	WRONG TECHNIQUE IN DRUG USAGE PROCESS	102
74	EMOTIONAL DISORDER	101
75	DIARRHEA	98
76	NOCTURIA	98
77	PINS AND NEEDLES	97
78	ABDOMINAL PAIN	96
79	INDIGESTION	96
80	ACNE	94
81	POST 5-ALPHA-REDUCTASE INHIBITOR SYNDROME	90
82	APATHY	89
83	MAJOR DEPRESSION	88
84	ASTHMA	85
85	CONSTIPATION	85
86	COUGH	84
87	PROSTATE CANCER	84
88	VARICOCELE	84
89	MUSCLE SPASMS	83
90	OFF LABEL USE	83
91	MUSCULAR WEAKNESS	80
92	ENDOCRINE DISORDER	78
93	ORGASM ABNORMAL	78
94	HAEMORRHOIDS	77
95	PAINFUL EJACULATION	77
96	SINUSITIS	77
97	ANORGASMIA	76
98	BLOOD CHOLESTEROL INCREASED	76
99	ADVERSE DRUG REACTION	75
100	COMPLETED SUICIDE	75

Latest Known Outcomes for Reactions Reported for PROPECIA

	Latest Known Outcome for Reported Reactions	Number of Cases
1	Unknown Outcome	2683
2	Patient has not recovered/symtoms have not resolved	2196
3	Patient recovered	656
4	Patient is recovering/symptoms resolving	457
5	Patient died	93
6	Patient has recovered but has consequent health issues	15

Yearly FDA Adverse Event Reports (Table)

Year	Number of Reports
2004	79
2005	95
2006	136
2007	138
2008	116
2009	131
2010	157
2011	260
2012	689
2013	927
2014	577
2015	494
2016	259
2017	199
2018	180
2019	221
2020	176
2021	163
2022	109
2023	86
2024	64
2025	65
2026	19

Reports by Patient Age Group (Table)

Age Group	Number of Reports
0-10	35
11-20	93
21-30	649
31-40	620
41-50	448
51-60	304
61-70	153
71-80	71
81-90	29
91+	11

Based on 2413 reports that included a patient age.

PROPECIA Total Reports

Male	Female	Unknown	Total
4903	214	223	5,340

Top Countries Reporting

	Country	Number of Reports
1	United States	3055
2	Japan	150
3	United Kingdom	146
4	Germany	107
5	Canada	89
6	France	82
7	Italy	68
8	Sweden	29
9	Spain	23
10	Israel	22

Outcomes for Reports

Serious: 3376
Not Serious: 1964
Note: A serious outcome means the adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition.

Top Indications

Androgenetic alopecia
HAIR LOSS
Hair disorder

Top Companies Reporting

ORGANON

Safety-Related FDA Updates

FDA Approval Date: 1997-12-19

PROPECIA (FINASTERIDE) Rx Drug:
Safety-related Labeling Changes

Have experience (good or bad) with PROPECIA? Rate PROPECIA at Ask a Patient.

For serious adverse events, report them to the FDA by contacting the drug manufacturer or report directly through the MedWatch voluntary reporting form.

Notes

Events listed on this page represent serious and often rare adverse events reported to pharmaceutical companies, and do not represent typical side effects for the medication. Find common side effects on the most recent official drug label This report, created by AskaPatient.com, is derived from the cases for PROPECIA reported to the United States Food and Drug Administration (FDA) FDA Safety Information and Adverse Event Reporting System (FAERS) and obtained from Open FDA. Data was last updated with reports received through July 30, 2026.

This summary includes ALL reports where the drug is a "primary OR secondary OR suspected interacting" drug. Typically, reports are filed for the most serious type or "event" and do not represent incidental or minor side effects. The majority of these reports are mandatory reports submitted by pharmaceutical companies, who receive complaints from consumers. The reactions, side effects, or "adverse events," represent up to the 20 most frequently occuring events in the database for a drug related to the event. This report also features counts of latest known outcomes associated with reported side effects, but does not provide the specific outcomes for specific adverse events.

Adverse Event Reports are submitted to the FAERS database by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers). Health care providers such as doctors (voluntary reporting), and patients themselves (voluntary reporting) report to the FDA directly through the MedWatch program. Those MedWatch reports are coded and included in the FAERS database. This report mainly consists of the mandatory reports, because the MedWatch reports are a small percentage (3 - 5%) of total reports. Link to the MedWatch summary report at the top of the page for a summary of the directly reported (voluntary) adverse events for this drug.The number of reports included here might differ somewhat from the number of reports in the downloadable quarterly FAERS reports and in the online FAERS dashboard, due to lags in reporting, drug name differences, duplicates, and other factors. Open FDA states that it only includes the most recent version of a case report. It also adds the disclaimer: "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated."

FDA uses the "MedDRA" classification system to describe reported adverse reactions. MedDRA is a standardized medical terminology that facilitates sharing of regulatory information internationally. In some cases, "patient friendly" terms for the layman designated by MedDRA have been substituted for medical jargon. Please contact us with questions or comments about this report.