Table 2.
Description of adverse reactions | N | (%) |
Minor adverse reactions | 90 | 71.4 |
Gastric irritation (nausea, vomiting), abdominal pain | 37 | 29.3 |
Itchy skin | 20 | 15.9 |
Arthralgia or arthritis | 13 | 10.3 |
Headache | 6 | 4.8 |
Sweat and urine orange | 6 | 4.8 |
Behavior change (euphoria, insomnia, anxiety, and drowsiness) | 4 | 3.1 |
Peripheral neuropathy (burning of the extremities) | 3 | 2.4 |
Fever | 1 | 0.8 |
Major adverse reactions | 8 | 6.4 |
Exanthema | 3 | 2.4 |
Hepatotoxicity (vomiting, hepatitis, changes in liver function tests) | 3 | 2.4 |
Thrombocytopenia, leukopenia, eosinophilia, hemolytic anemia, agranulocytosis, vasculitis | 2 | 1.6 |
Other§) | 28 | 22.2 |
Total | 126 | 100.0 |
ADRs not described in the MoH Guia de Vigilância Epidemiológica: adenopathy, hallucinations, amenorrhea, anemia, increased uric acid, increased menstrual flow, painful urination, rash, weakness, jaundice, desquamative (scaly) lesions on the knees, urticarial lesions, malaise (sickness), other psychotic disorders, allergic reactions, and dizziness.