TABLE 2.
Adverse drug reactions.
| Adverse drug reactions (ADRs) | Definition |
|---|---|
| Allergic skin reaction | Any skin change characterized by pruritis, rash, acne, or photosensitivity reported by the patients and cross-examined by the physician for possible anti-TB drugs effects |
| Anemia | At least 1 serum hemoglobin value <13 g/dl (male) or <11.5 g/dl (female)* |
| Arthralgia | Joint pain reported by the patients and recorded by the physician with or without arthritis |
| Body pain and headache | As reported by the patients |
| Dyspnoea | Any difficulty in breathing as reported by the patients and evaluated by the physician |
| Gastrointestinal disturbances | Any case of gastritis, nausea, vomiting, abdominal pain, or diarrhea reported by the patients or documented by the physician |
| Gynecomastia | Consistent and painful enlargement of breast documented by the physician for possible anti-TB drug effects |
| Hemoptysis | Spitting of blood with cough as reported by the patients and documented by the physician |
| Hepatotoxicity | In the absence of symptoms, at least 1 elevated serum value of transaminase or bilirubin five times higher than the upper normal value or three times higher in case of symptoms |
| Hypothyroidism | At least 1 increased serum TSH value >10 IU/ml* |
| Hypokalemia | 1 serum potassium value <3 mmol/L* |
| Hyperuricemia | At least 1 serum increased value of uric acid >9 mg/dl* |
| Nephrotoxicity | At least 1 serum creatinine value >130 μmol/L* |
| Ototoxicity | Hearing loss or tinnitus as reported by the patients and confirmed by audiometry or clinician examination |
| Peripheral neuropathy | Symptoms linked with numbness or burning sensation of extremities as reported by the patients and evaluated by the physician |
| Psychiatric disturbances | Any cases of depression or psychosis evaluated by a psychologist or psychiatrist |
| Sleep disturbances | As reported by the patients and documented by the physician |
| Swelling | Evaluated by the physician by physical examination |
| Vertigo and dizziness | As reported by the patients and evaluated by the physician |
| Visual disturbances | DIFFICULTY in vision as reported by the patients |
Normal Ranges: Alanine aminotransferases (ALT) = up to 41 U/L; Bilirubin total = Up to 1.2 mg/dl; serum creatinine = 0.74–1.35 mg/dl; Hemoglobin (Hb) Male (13–18) g/dl Female (11.5–16.5) g/dl.