Side effect | Males (136 mg/day)
[a] (n = 1248) (%) |
Females (18 mg/day)
[a] (n = 1258) (%) |
Total (77 mg/day)
[a] (n = 2506) (%) |
---|---|---|---|
Elevated liver enzymes [b] | 12.5 | 3.6 | 9.6 |
Gynecomastia, breast pain | 4.9 | 1.0 | 2.9 |
Overweightness, weight gain | 0.9 | 4.1 | 2.5 |
Headache, migraine | – | 3.4 | 1.7 |
Depression, anxiety, nightmares, mood swings | 1.0 | 1.8 | 1.4 |
Gastrointestinal dysfunction | 0.2 | 2.3 | 1.2 |
Thyroid dysfunction | 0.2 | 1.8 | 1.0 |
Skin changes ( pigmentation, chloasma, others) | 0.3 | 1.4 | 0.8 |
Edema | – | 1.1 | 0.6 |
Adrenal insufficiency or hyperplasia | 0.2 | 0.8 | 0.5 |
Tiredness, lethargy, apathy | 0.6 | 0.6 | 0.6 |
Alopecia, hair growth | 0.2 | 0.2 | 0.2 |
Increased asthma attack rates | – | 0.3 | 0.2 |
Osteoporosis | 0.2 | 0.08 | 0.2 |
More frequently prone to attacks | 0.2 | 0.2 | 0.2 |
Diabetes mellitus | 0.08 | 0.08 | 0.08 |
Total (excluding elevated liver enzymes) | 9.0 | 19.1 | 14.0 |
Notes: Data from the SExual-HOrmonal Surveillance STudy (SEHOST), a long-term pharmacoepidemiologic active surveillance study. The sample included males and females age 3 to 75 years with precocious puberty, hyperandrogenism, sexual deviance, and/or transgenderism; prostate cancer was not included. Sources: [1] [2] |
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