Tadalafil (Generic) Hair and Skin Changes: What the Evidence Actually Shows

At a glance

  • Documented skin effect / Flushing
  • Flushing, 20 mg as needed for ED / 3% vs 1% on placebo [1]
  • Flushing, 5 mg once daily for ED / 3% vs 1% on placebo [1]
  • Flushing in BPH and ED/BPH trials / Not listed among reactions reported by at least 1% of tadalafil users and more often than placebo [1]
  • Serious skin reactions / Stevens-Johnson syndrome and exfoliative dermatitis reported; history of serious hypersensitivity is a contraindication [1][2]
  • Hormones / No adverse effect on mean testosterone, LH or FSH at 10 or 20 mg [2]

Does tadalafil cause hair loss?

In the Cialis oral-tablet trial tables, alopecia is not listed among the reported adverse reactions [1]. The tables list reactions that met a reporting threshold of at least 1% or 2%, depending on the table, and that occurred more often with tadalafil than placebo, so absence from them does not rule out an uncommon effect [1].

Finasteride and dutasteride, the 5-alpha reductase inhibitors, are considered first-line treatment for androgenetic hair loss in men [3]. Tadalafil is a PDE5 inhibitor and is not in that class [1].

What skin reactions does tadalafil cause?

Flushing is the main skin reaction in the Cialis trials. In eight 12-week placebo-controlled ED trials, flushing was reported by 1% of men on placebo, 2% on tadalafil 5 mg as needed, and 3% on both 10 mg and 20 mg as needed [1]. In three 12-week once-daily ED trials, flushing was 1% on placebo, 1% on 2.5 mg and 3% on 5 mg [1].

In the three 12-week BPH and ED/BPH trials, flushing was not listed among reactions reported by at least 1% of tadalafil users and more often than placebo [1]. The table for those trials lists headache, dyspepsia, back pain, nasopharyngitis, diarrhea, pain in extremity, myalgia and dizziness [1].

Serious skin reactions are different. The Cialis label states that tadalafil is contraindicated in people with a known serious hypersensitivity to tadalafil and lists Stevens-Johnson syndrome and exfoliative dermatitis among reported hypersensitivity reactions [1]. The Adcirca label's postmarketing list includes urticaria, Stevens-Johnson syndrome and exfoliative dermatitis [2]. These are serious reactions, not the common flushing in the trial tables.

Does tadalafil help hair growth?

Minoxidil is an FDA-approved treatment for androgenetic alopecia [4]. Laboratory research has proposed potassium-channel activity as one possible mechanism for minoxidil, and a cell study found increased VEGF expression in dermal papilla cells; these findings do not show that tadalafil affects hair follicles [5][6].

Tadalafil is approved for erectile dysfunction, for the signs and symptoms of BPH, and, as Adcirca (tadalafil 20 mg tablets), for pulmonary arterial hypertension, not for hair growth [1][2].

What about finasteride and testosterone?

A 26-week randomized trial enrolled 695 men with BPH symptoms and prostate enlargement; 345 took tadalafil 5 mg plus finasteride 5 mg and 350 took placebo plus finasteride [7]. Its reported outcomes were urinary symptom scores, erectile function and adverse events [7]. The Cialis label recommends up to 26 weeks of use when tadalafil is combined with finasteride to start BPH treatment [1].

The Adcirca label, which covers tadalafil 20 mg tablets for pulmonary arterial hypertension, reports no adverse effect of tadalafil 10 mg or 20 mg on mean concentrations of testosterone, luteinizing hormone or follicle-stimulating hormone [2]. That is a statement about hormone levels, not a claim that tadalafil treats low testosterone.

Frequently asked questions

Does tadalafil cause hair loss?
Alopecia does not appear in the Cialis oral-tablet adverse-reaction tables [1]. Finasteride and dutasteride, not tadalafil, are the 5-alpha reductase inhibitors used for androgenetic hair loss [3].
Can tadalafil help with hair growth?
Tadalafil is approved for ED, BPH and, as Adcirca, PAH, not for hair growth [1][2]. Minoxidil and finasteride were superior to placebo for androgenetic alopecia in a meta-analysis of randomized trials [4].
Is flushing common with tadalafil?
In the Cialis ED trials, flushing was 3% with 20 mg as needed and 3% with 5 mg once daily, versus 1% on placebo [1].
Is flushing dangerous?
Flushing is a common trial reaction [1]. Stevens-Johnson syndrome and exfoliative dermatitis are serious hypersensitivity reactions reported with tadalafil, and a history of serious hypersensitivity is a contraindication [1][2].
Does tadalafil affect testosterone?
The Adcirca label reports no adverse effect of tadalafil 10 mg or 20 mg on mean testosterone, luteinizing hormone or follicle-stimulating hormone [2].

References

  1. U.S. National Library of Medicine, DailyMed. Cialis (tadalafil) tablets, Lilly prescribing information. Cialis (tadalafil) tablets, Lilly label
  2. U.S. National Library of Medicine, DailyMed. Adcirca (tadalafil) tablets, Lilly prescribing information. Adcirca (tadalafil) tablets, Lilly label
  3. Hirshburg JM, Kelsey PA, Therrien CA, Gavino AC, Reichenberg JS. Adverse Effects and Safety of 5-alpha Reductase Inhibitors (Finasteride, Dutasteride): A Systematic Review. J Clin Aesthet Dermatol. 2016;9(7):56-62. Adverse Effects and Safety of 5-alpha Reductase Inhibitors (Finasteride, Dutasteride): A Systematic Review
  4. Adil A, Godwin M. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis. J Am Acad Dermatol. 2017;77(1):136-141.e5. The effectiveness of treatments for androgenetic alopecia: A systematic review and meta-analysis
  5. Messenger AG, Rundegren J. Minoxidil: mechanisms of action on hair growth. Br J Dermatol. 2004;150(2):186-94. Minoxidil: mechanisms of action on hair growth
  6. Lachgar S, Charveron M, Gall Y, Bonafe JL. Minoxidil upregulates the expression of vascular endothelial growth factor in human hair dermal papilla cells. Br J Dermatol. 1998;138(3):407-11. Minoxidil upregulates the expression of vascular endothelial growth factor in human hair dermal papilla cells
  7. Casabé A, Roehrborn CG, Da Pozzo LF, Zepeda S, Henderson RJ, Sorsaburu S, et al. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia. J Urol. 2014;191(3):727-33. Efficacy and safety of the coadministration of tadalafil once daily with finasteride for 6 months in men with lower urinary tract symptoms and prostatic enlargement secondary to benign prostatic hyperplasia
Evidence overview for tadalafil generic: Tadalafil (Generic) Hair and Skin Changes: What the Evidence Actually Shows