Table 2. The frequency of adverse drug reactions.
| Adverse drug reaction | Subjects (n=712) | Total events | Resolved events | Unresolved events | Unknown results |
|---|---|---|---|---|---|
| Skin and appendages disorders | 18 (2.5) | 18 | 13 | 1 | 4 |
| Rash | 4 (0.6) | 4 | 3 | 1 | 0 |
| Pruritus | 3 (0.4) | 3 | 3 | 0 | 0 |
| Acne | 2 (0.3) | 2 | 2 | 0 | 0 |
| Alopecia | 2 (0.3) | 2 | 1 | 0 | 1 |
| Folliculitis | 2 (0.3) | 2 | 2 | 0 | 0 |
| Other skin disorder | 2 (0.3) | 2 | 1 | 0 | 1 |
| Dermatophytosis | 1 (0.1) | 1 | 1 | 0 | 0 |
| Seborrhea | 1 (0.1) | 1 | 0 | 0 | 1 |
| Verruca | 1 (0.1) | 1 | 0 | 0 | 1 |
| Gastro-intestinal system disorders | 9 (1.3) | 10 | 8 | 0 | 2 |
| Dyspepsia | 8 (1.1) | 8 | 6 | 0 | 2 |
| Diarrhea | 2 (0.3) | 2 | 2 | 0 | 0 |
| Psychiatric disorders | 13 (1.8) | 13 | 11 | 1 | 1 |
| Libido decreased | 9 (1.3) | 9 | 9 | 0 | 0 |
| Depression | 2 (0.3) | 2 | 1 | 0 | 1 |
| Insomnia | 1 (0.1) | 1 | 1 | 0 | 0 |
| Somnolence | 1 (0.1) | 1 | 0 | 1 | 0 |
| Reproductive disorders, male | 12 (1.7) | 12 | 5 | 3 | 4 |
| Impotence | 7 (1.0) | 7 | 3 | 3* | 1† |
| Sexual function abnormality | 4 (0.6) | 4 | 1 | 0 | 3‡ |
| Ejaculation disorder | 1 (0.1) | 1 | 1 | 0 | 0 |
| Liver and biliary system disorders | 5 (0.7) | 9 | 9 | 0 | 0 |
| SGPT increased | 4 (0.6) | 5 | 5 | 0 | 0 |
| SGOT increased | 2 (0.3) | 3 | 3 | 0 | 0 |
| Bilirubinaemia | 1 (0.1) | 1 | 1 | 0 | 0 |
| Body as a whole, general disorders | 5 (0.7) | 5 | 5 | 0 | 0 |
| Fatigue | 5 (0.7) | 5 | 5 | 0 | 0 |
| Resistance mechanism disorders | 1 (0.1) | 1 | 1 | 0 | 0 |
| Pharyngitis | 1 (0.1) | 1 | 1 | 0 | 0 |
| Respiratory system disorders | 1 (0.1) | 1 | 1 | 0 | 0 |
| Epistaxis | 1 (0.1) | 1 | 1 | 0 | 0 |
| Metabolic and nutritional disorders | 2 (0.3) | 2 | 1 | 1 | 0 |
| Hypertriglyceridaemia | 1 (0.1) | 1 | 1 | 0 | 0 |
| Weight increase | 1 (0.1) | 1 | 0 | 1 | 0 |
| Central and peripheral nervous system disorders | 2 (0.3) | 2 | 2 | 0 | 0 |
| Paraesthesia | 1 (0.1) | 1 | 1 | 0 | 0 |
| Dizziness | 1 (0.1) | 1 | 1 | 0 | 0 |
| Endocrine disorders | 3 (0.4) | 3 | 1 | 1 | 1 |
| Gynaecomastia | 2 (0.3) | 2 | 1 | 1∥ | 0 |
| Testosterone decreased | 1 (0.1) | 1 | 0 | 0 | 1 |
| Heart rate and rhythm disorders | 2 (0.3) | 2 | 2 | 0 | 0 |
| Palpitation | 2 (0.3) | 2 | 2 | 0 | 0 |
| Special senses other, disorders | 1 (0.1) | 1 | 0 | 0 | 1 |
| Taste perversion | 1 (0.1) | 1 | 0 | 0 | 1 |
| Secondary terms | 1 (0.1) | 1 | 1 | 0 | 0 |
| Surgical intervention§ | 1 (0.1) | 1 | 1 | 0 | 0 |
Values are presented as number (%) or number only. SGPT: serum glutamic-pyruvic transaminase, SGOT: serum glutamic oxaloacetic transaminase. *After the end of the study, 2 impotence events were resolved even under dutasteride treatment. Another patient who discontinued dutasteride was unreachable after the end of the study. †One event with the unknown prognosis of sexual dysfunction continued to take dutasteride. ‡Three events with the unknown prognosis of sexual dysfunction continued to take dutasteride 0.5 mg and didn't take any medicine to treat sexual dysfunction. §Posterior tooth extraction. ∥Gynaecomastia was reported only after 4 days of treatment with dutasteride, which was stopped after 1 month and was finally resolved after the end of the study.