Table 4.
Clinical presentation | Number of trials reporting data (n = 20) | Symptoms or long-term consequences in clinical trials (proportion of patients) | Number of observational studies reporting data (n = 30) | Symptom or long-term consequence in observational studies (proportion of patients) | Drug suspected |
---|---|---|---|---|---|
Breast and lactation disorders | 16 (80%) |
Galactorrhoea: 4–62% Gynaecomastia: 3–34%a |
21 (70%) |
Galactorrhoea: 6–85% Gynaecomastia: 5–60% |
Antipsychotics, oral contraceptives, and prokinetic drugs |
Menstrual cycle bleeding disorders | 15 (75%) |
Amenorrhoea: 11–100% Oligomenorrhoea: 15–55% Other disturbances in the menstrual cycle: 3–100% |
24 (80%) |
Amenorrhoea: 6–100% Oligomenorrhoea: 8–50% Other disturbances in the menstrual cycle: 3–100% |
Dopamine antagonists, antipsychotics, antidepressants, oestrogen, anxiolytics, H2-antihistamines, antihypertensives, and prokinetic drugs |
Sexual dysfunctions | 9 (45%) |
Ejaculatory or erectile dysfunctions: 1–32% Decreased libido: 1–77% Difficulty achieving orgasm: 9–22% |
11 (37%) |
Ejaculatory or erectile dysfunctions: 4–100% Decreased libido: 11–62% Difficulty achieving orgasm: 11–65% |
Antipsychotics |
Female genital system disorders | 0 (0%) | NA | 1 (3%) | Vaginal dryness during intercourse: 53% (42/80) females | Antipsychotics |
Hair and skin abnormalities | 2 (10%) | Facial acne and hirsutism: 3–5% | 0 (0%) | NA | Antipsychotics |
Infertility | 1 (5%) | Anovulation: 34% (2/6) | 3 (10%) |
General infertility: 31–29% Oligospermia: 15% (1/7) of males |
Prokinetic drugs, antipsychotics |
HPL hyperprolactinaemia, NA not available
aOne trial reported a frequency of 100% based on one patient with drug-induced HPL