Finasteride Appetite & Cravings Changes: What the Evidence Actually Shows

At a glance

  • Appetite or cravings on the labels / Not listed as an adverse reaction of the 1 mg or 5 mg tablet [1][2]
  • What the 1 mg trials listed / Decreased libido 1.8% vs 1.3%, erectile dysfunction 1.3% vs 0.7%, ejaculation disorder 1.2% vs 0.7% [1]
  • Trial size / 945 men on finasteride 1 mg, 934 on placebo, 12 months [1]
  • What the 5 mg trial listed / Impotence 8.1% vs 3.7% and decreased libido 6.4% vs 3.4% in year one of PLESS [2]
  • Food effect / Bioavailability about 65%, unaffected by food; with or without meals [1]
  • Hormone effect / Serum DHT down about 65% within 24 hours; testosterone and estradiol up about 15%, still in normal range [1]
  • Safety reporting in hair-loss trials / 34 trials reviewed; none had adequate safety reporting [3]

Does finasteride change appetite?

Neither the 1 mg nor the 5 mg label lists appetite change or cravings as an adverse reaction [1][2]. What the labels do list, drawn from the trials, is a small cluster of sexual effects.

The 1 mg label reports three 12-month controlled trials: decreased libido in 1.8% versus 1.3% on placebo, erectile dysfunction in 1.3% versus 0.7%, and ejaculation disorder in 1.2% versus 0.7%. Overall, 3.8% of men on finasteride (36 of 945) reported one or more of these versus 2.1% on placebo (20 of 934) [1].

The 5 mg label reports the four-year PLESS study of 3,040 men with BPH. In year one, impotence was 8.1% versus 3.7% on placebo, decreased libido 6.4% versus 3.4%, decreased ejaculate volume 3.7% versus 0.8%, breast enlargement 0.5% versus 0.1%, breast tenderness 0.4% versus 0.1% and rash 0.5% versus 0.2%. In years two to four there was no significant difference between groups in impotence, decreased libido or ejaculation disorder [2].

What the trials actually recorded

These were hair-growth and prostate-symptom trials, not metabolic studies. In the two vertex baldness trials, a self-administered sexual function questionnaire at month 12 showed statistically significant differences in favor of placebo in three of four domains: sexual interest, erections and perception of sexual problems [1].

Adverse-event capture in this literature was limited. A meta-analysis of 34 finasteride trials for hair loss found that none had adequate safety reporting, 19 were partially adequate and 12 inadequate, and funnel plots suggested systematic under-detection of sexual adverse effects [3].

What the postmarketing lists add

Both labels also carry postmarketing reports, meaning events reported after approval rather than seen in the trials: hypersensitivity reactions, testicular pain, hematospermia, breast tenderness and enlargement, male breast cancer, depression, suicidal ideation and behavior, and sexual dysfunction that continued after stopping treatment [1]. These reports are voluntary, so their frequency and whether finasteride caused them cannot reliably be determined [1][2].

What finasteride does change

Finasteride blocks Type II 5-alpha-reductase, the enzyme that converts testosterone to dihydrotestosterone (DHT). A 1 mg tablet reaches about 65% suppression of serum DHT within 24 hours, mean circulating testosterone and estradiol rise by about 15% but stay within the normal range, and finasteride has no affinity for the androgen receptor [1].

Food is a separate matter. Bioavailability is about 65% and is not affected by food, and the label states the tablet can be taken with or without meals [1].

Reporting a suspected reaction

The Propecia label lists FDA MedWatch (1-800-FDA-1088 or www.fda.gov/medwatch) and the manufacturer Organon (1-844-674-3200) for reporting suspected adverse reactions [1].

Frequently asked questions

Does food affect how finasteride works?
No. Bioavailability is about 65% and is not affected by food, and the label says the tablet can be taken with or without meals [1].
What side effects did the hair-loss trials actually track?
The 1 mg trials reported decreased libido 1.8% vs 1.3% on placebo, erectile dysfunction 1.3% vs 0.7%, and ejaculation disorder 1.2% vs 0.7%, with 3.8% vs 2.1% reporting one or more [1]. A meta-analysis of 34 hair-loss trials found that none had adequate safety reporting [3].
Does the 5 mg tablet have a different side-effect profile from the 1 mg tablet?
In year one of the four-year PLESS trial of 3,040 men with BPH, impotence was 8.1% vs 3.7% on placebo and decreased libido 6.4% vs 3.4%; in years two to four there was no significant difference in impotence, decreased libido or ejaculation disorder [2].
Which hormones does finasteride change?
A 1 mg tablet suppresses serum DHT by about 65% within 24 hours, and mean testosterone and estradiol rise by about 15% while remaining in the normal range; finasteride has no affinity for the androgen receptor [1]. The label does not describe effects on appetite.
Where can a suspected side effect be reported?
The label lists FDA MedWatch at 1-800-FDA-1088 and www.fda.gov/medwatch, or the manufacturer Organon at 1-844-674-3200 [1].
Does the label list mood effects?
Depression and suicidal ideation and behavior appear as postmarketing reports in the labels, and because those reports are voluntary, their frequency and whether finasteride caused them cannot reliably be determined [1][2].

References

  1. U.S. National Library of Medicine, DailyMed. Propecia (finasteride 1 mg) tablets, Organon prescribing information. Propecia (finasteride 1 mg) tablets, Organon label
  2. U.S. National Library of Medicine, DailyMed. Proscar (finasteride 5 mg) tablets, Organon prescribing information. Proscar (finasteride 5 mg) tablets, Organon label
  3. Belknap SM, Aslam I, Kiguradze T, Temps WH, Yarnold PR, Cashy J, et al. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis. JAMA Dermatol. 2015;151(6):600-6. Adverse Event Reporting in Clinical Trials of Finasteride for Androgenic Alopecia: A Meta-analysis
Evidence overview for finasteride: Finasteride Appetite & Cravings Changes: What the Evidence Actually Shows