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REPORTED SIGNALS

finasteride

Propecia · Proscar

Registration status unknownDrugglp-1Camber Pharmaceuticals, Inc.
ORAL

1 INDICATIONS & USAGE Finasteride tablets USP are indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY. Efficacy in bitemporal recession has not been established. Finasteride tablets USP are not indicated for use in women. • Finasteride tablets USP are 5α-reductase inhibitors indicated for the treatment of male pattern hair loss (androgenetic alopecia) in MEN ONLY ( 1 ). • Finasteride tablets USP are not indicated for use in women ( 1 , 4 , 5.1 ).

Mechanism. 12.1 Mechanism of Action Finasteride is a competitive and specific inhibitor of Type II 5α-reductase, an intracellular enzyme that converts the androgen testosterone into DHT. Two distinct isozymes are found in mice, rats, monkeys, and humans: Type I and II. Each of these isozymes is differentially expressed in tissues and developmental stages. In humans, Type I 5α-reductase is predominant in the sebaceous glands of most regions of skin, including scalp, and liver. Type I 5α-reductase is responsible for approximately one-third of circulating DHT. The Type II 5α-reductase isozyme is primarily found in prostate, seminal vesicles, epididymides, and hair follicles as well as liver, and is responsible for two-thirds of circulating DHT. In humans, the mechanism of action of finasteride is based on its preferential inhibition of the Type II isozyme. Using native tissues (scalp and prostate), in vitro binding studies examining the potential of finasteride to inhibit either isozyme revealed a 100-fold selectivity for the human Type II 5α-reductase over Type I isozyme (IC 50 =500 and 4.2 nM for Type I and II, respectively). For both isozymes, the inhibition by finasteride is accompanied by reduction of the inhibitor to dihydrofinasteride and adduct formation with NADP+. The turnover for the enzyme complex is slow (t 1/2 approximately 30 days for the Type II enzyme complex and 14 days for the Type I complex). Inhibition of Type II 5α-reductase blocks the peripheral conversion of testost

58,942
reports (FAERS)
64.3%
reported as serious
3,929
fatal reports (6.7%)
15
signals above threshold
2006
first approved
2026-07
last updated
TIMELINE · FDA MILESTONES
Approved
2006
2005
2026
SIGNAL RANKING · ROR

What stands out in the reports.

On the labelNew signalUnknown & frequent
Symptom
0.1110100
ROR [95% CI]
Sexual Dysfunction
94.7 [90.599.2]
LOSS OF Libido
80.9 [76.785.5]
Erectile Dysfunction
72.6 [70.275.2]
Libido Decreased
55.1 [52.358.1]
Cognitive Disorder
12.4 [11.813.1]
Adverse DRUG Reaction
11.9 [11.412.3]
Suicidal Ideation
6.5 [6.16.8]
Adverse Event
6.4 [6.06.7]
Depression
6.0 [5.86.2]
Anxiety
4.0 [3.84.1]
Atrial Fibrillation
3.1 [2.93.4]
Insomnia
2.8 [2.72.9]
Confusional State
2.2 [2.12.4]
Asthenia
2.1 [2.02.2]
Constipation
2.0 [1.92.2]

ROR = reporting odds ratio (log scale). A value above 1 means the symptom is reported more often for this product than for all other products combined. This measures how much it stands out in reports — not cause, not risk.

INTERPRETATION
Auto-generated

Finasteride reports show sexual dysfunction, loss of libido, and erectile dysfunction are disproportionately reported. This is logical as finasteride reduces hormones involved in sexual function. Suicidal ideation, depression, and anxiety are also reported more often than average. While 'frequently reported' isn't 'frequently caused', these signals warrant attention. This does not replace medical advice.

This does not replace medical advice.

LABEL VERSUS REPORT
On the label

No signals currently mapped to the label.

Newly reported
Sexual Dysfunction
LOSS OF Libido
Erectile Dysfunction
Libido Decreased
Cognitive Disorder
Adverse DRUG Reaction
Suicidal Ideation
Adverse Event
REPORTS OVER TIME

Report volume per quarter.

20062007200820092011
RECALL HISTORY · 0 ON RECORD

No recalls on record.

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SOURCE & CITATION
HealthProves. finasteride — reported signals. Retrieved 2026-07-04. Source: openFDA (FAERS). healthproves.com/finasteride/
FAERS58,942 records
Retrieved2026-07-04
MethodROR / disproportionality