Finasteride Label Updates 2020 to 2026: What Changed and Why It Matters

What changed, in order

The FDA sent a safety labeling change order on May 31, 2022 under section 505(o)(4) of the Food, Drug, and Cosmetic Act, citing new safety information on suicidal ideation and behavior, an additional risk of sexual dysfunction, and psychoneurocognitive adverse events [2]. Propecia supplement S-030 was approved August 1, 2022 and changed the postmarketing nervous system and psychiatric entry from 'depression' to 'depression, suicidal ideation and behavior' [1][2]. The June 15, 2021 label, supplement S-028, had listed only 'depression' [1][2]. The revised wording went into section 6.2, Postmarketing Experience [4].

The years with no labeling supplement

The Drugs@FDA supplement lists show no finasteride labeling supplement in 2020, and none in 2023, 2024 or 2025 [1][3]. Propecia's most recent supplement is still S-030, and the label currently in effect dates from October 14, 2024 [1][4]. Proscar's list shows labeling supplements on April 13, June 15 and August 25, 2021, then nothing until S-050 on March 18, 2026 [3]. So there was no 2023 revision, and no separate 2022 update for depression followed by a 2023 update for suicidality.

Reading the 2022 wording correctly

The label does not say finasteride causes suicidal thinking. It states that these reports are voluntary, come from a population of uncertain size, and that a causal relationship cannot reliably be established [4].

The same section lists sexual function reports: 'sexual dysfunction that continued after discontinuation of treatment, including erectile dysfunction, libido disorders, ejaculation disorders, and orgasm disorders', plus male infertility and poor seminal quality, with normalization or improvement of seminal quality reported after discontinuation [4]. The current Proscar label says persistent sexual events were reported rarely in men taking 5 mg for BPH; most were older and taking other medicines, and the independent role of Proscar is unknown [5].

The trial reassurance was not removed. Section 6.1 of the Propecia label still states that resolution occurred in men who discontinued therapy because of these side effects and in most of those who continued [4].

What the trials measured

In the three 12-month controlled Propecia trials, 945 men took 1 mg and 934 took placebo. Drug-related decreased libido was 1.8% vs 1.3%, erectile dysfunction 1.3% vs 0.7%, and ejaculation disorder 1.2% vs 0.7%; overall, 3.8% (36 of 945) reported one or more of these versus 2.1% (20 of 934) on placebo, p=0.04 [4]. Discontinuation for drug-related sexual events was 1.2% vs 0.9%, and the incidence of each event fell to 0.3% or lower by year five [4]. On a self-administered sexual function questionnaire at month 12, results favored placebo in three of four domains: sexual interest, erections, and perception of sexual problems [4].

A meta-analysis of 15 randomized placebo-controlled trials in 4,495 men with androgenetic alopecia found a relative risk of sexual dysfunction of 1.57 (95% CI 1.19 to 2.08), and 1.66 (1.20 to 2.30) for finasteride alone [6]. A separate review of 34 finasteride trials for hair loss found that none had adequate safety reporting, that 76% evaluated safety for one year or less, and that funnel plots suggested under-detection of sexual adverse effects [7].

The March 2026 Proscar label

Proscar's current label took effect March 18, 2026 as supplement S-050 [3]. It lists depression, suicidal ideation and male breast cancer among postmarketing reports [5]. The 5 mg product remains indicated for symptomatic BPH in men with an enlarged prostate, and the label's limitation of use states that it is not approved for the prevention of prostate cancer [5].

The label states that Proscar reduces serum PSA by approximately 50% within six months, that a new PSA baseline should be established at least six months after starting treatment with periodic monitoring thereafter, and that an isolated PSA value in a man treated for six months or more should be doubled for comparison with normal ranges [5]. Percent free PSA is unchanged [5]. For Propecia, mean PSA fell from 0.7 to 0.5 ng/mL at month 12 in men aged 18 to 41 [4].

Depression and suicide: two large cohorts, often confused

The Ontario study (Welk et al., JAMA Internal Medicine 2017) followed 93,197 men aged 66 or older starting a 5-alpha reductase inhibitor, mostly for BPH. Suicide hazard ratio was 0.88 (95% CI 0.53 to 1.45); self-harm was 1.88 (1.34 to 2.64) in the first 18 months only; depression was 1.94 (1.73 to 2.16) in the first 18 months and 1.22 (1.08 to 1.37) afterward, with absolute increases of 17 (self-harm) and 237 (depression) per 100,000 patient-years [8].

The Swedish register study (Garcia-Argibay et al., JAMA Network Open 2022) followed 2,236,876 men aged 50 to 90, of whom 70,645 started finasteride, at a median age of 73 at treatment start. Depression hazard ratio was 1.61 (1.48 to 1.75) and constant over time; suicide was not significantly associated (1.22, 0.99 to 1.49) [9].

Smaller studies looked at a different group: men who reported persistent symptoms. Standardized interviews with 71 otherwise healthy men aged 21 to 46 who reported sexual side effects lasting at least three months after stopping found mean finasteride use of 28 months and mean persistence of 40 months; the group was self-selected and recall-biased, so it cannot show frequency or cause [10]. In a comparison of 61 former users with persistent sexual side effects against 29 never-users with hair loss, depressive symptoms on the BDI-II were present in 75% (46 of 61) vs 10% (3 of 29), P less than 0.0001; the design was small, self-selected and cross-sectional, so it cannot prove cause [11]. A study of 16 men with post-finasteride syndrome found altered neuroactive steroid levels in cerebrospinal fluid and plasma, alongside depression and erectile dysfunction [12]. A separate comparison of symptomatic users, asymptomatic users and never-users found higher depression scores in the symptomatic group but no evidence of androgen deficiency or persistent peripheral 5-alpha reductase inhibition [13].

The 1 mg tablet in the current label

The Propecia label says the dose is one 1 mg tablet once daily with or without food, that daily use for three months or more is generally needed before benefit is seen, that continued use is recommended to sustain benefit, and that withdrawal leads to reversal of effect within 12 months [4]. It is indicated for men only and is contraindicated in pregnancy; the label says women who are or may be pregnant should not handle crushed or broken tablets, and that the coating prevents contact only while tablets are intact [4]. The label states that no drug interactions of clinical importance have been identified; finasteride was tested with antipyrine, digoxin, propranolol, theophylline and warfarin without meaningful interactions [4]. Generic 1 mg and 5 mg tablets carry the same labeled risks as the brands [4].

See finasteride 1 mg for the 1 mg product [1][4].

Three claims the label record does not support

A boxed warning for depression, suicide or sexual dysfunction: there is none on either product [4][5]. A 2023 revision that moved psychiatric risk into Warnings and Precautions: the order was dated May 31, 2022, the supplement was approved August 1, 2022, and the text is in Postmarketing Experience [1][2]. A label that says sexual side effects always resolve after stopping: section 6.1 reports resolution in men who discontinued and in most who continued, while section 6.2 lists reports of dysfunction that continued after stopping [4].