Skip to main content
. 2023 Feb 17;37(2):153–166. doi: 10.1007/s40290-023-00462-2

Table 4.

Main clinical presentations of drug-induced HPL in clinical trials and observational studies

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