Table 3.
Adverse drug reactions observed during the treatment with Epzicom† (325 events in 202 subjects)
| Adverse drug reaction | Cases (%) |
|---|---|
| Blood and lymphatic system disorders | 4 (0.64) |
| Iron deficiency anaemia | 1 |
| Normochromic normocytic anaemia | 1 |
| Pancytopenia | 1 |
| Haemorrhagic diathesis | 1 |
| Cardiac disorders | 3 (0.48) |
| Atrioventricular block complete | 1 |
| Atrioventricular block first degree | 1 |
| Cardiac failure | 1 |
| Endocrine disorders | 1 (0.16) |
| Hyperthyroidism | 1 |
| Gastrointestinal disorders | 27 (4.33) |
| Abdominal discomfort | 2 |
| Abdominal pain | 1 |
| Abdominal pain upper | 2 |
| Ascites | 1 |
| Constipation | 1 |
| Diarrhoea | 5 |
| Gastritis | 2 |
| Gingivitis | 1 |
| Nausea | 7 |
| Pancreatitis acute | 2 |
| Reflux oesophagitis | 2 |
| Vomiting | 1 |
| Abdominal symptom | 1 |
| General disorders and administration site conditions | 7 (1.12) |
| Asthenia | 1 |
| Malaise | 3 |
| Pyrexia | 3 |
| Hepatobiliary disorders | 23 (3.69) |
| Cholelithiasis | 1 |
| Hepatic function abnormal | 7 |
| Hepatitis fulminant | 1 |
| Hyperbilirubinaemia | 8 |
| Jaundice | 1 |
| Liver disorder | 7 |
| Immune system disorders | 1 (0.16) |
| Immune reconstitution symdrome | 1 |
| Infections and infestations | 6 (0.96) |
| Hepatitis C | 2 |
| Herpes zoster | 3 |
| Influenza | 1 |
| Atypical mycobacterial infection | 1 |
| Injury, poisoning, and procedural complications | 2 (0.32) |
| Spinal compression fracture | 1 |
| Lumbar vertebral fracture | 1 |
| Investigations | 65 (10.42) |
| Alanine aminotransferase increased | 2 |
| Aspartate aminotransferase increased | 2 |
| Blood bilirubin increased | 19 |
| Blood cholesterol increased | 3 |
| Blood creatine phosphokinase increased | 1 |
| Blood creatinine increased | 1 |
| Blood glucose increased | 1 |
| Blood lactate dehydrogenase increased | 1 |
| Blood triglycerides increased | 14 |
| Blood uric acid increased | 8 |
| Gamma-glutamyltransferase increased | 14 |
| Glucose urine present | 1 |
| Blood urine present | 1 |
| Haemoglobin decreased | 1 |
| Liver function test abnormal | 3 |
| Low density lipoprotein increased | 1 |
| Platelet count decreased | 4 |
| Lymphocyte count increased | 1 |
| Neutrophil count decreased | 1 |
| White blood cell count decreased | 1 |
| Blood alkaline phosphatase increased | 4 |
| Metabolism and nutrition disorders | 87 (13.94) |
| Diabetes mellitus | 5 |
| Glucose tolerance impaired | 1 |
| Gout | 1 |
| Hypercalcaemia | 1 |
| Hypercholesterolaemia | 3 |
| Hypertriglycaeridaemia | 21 |
| Hyperuricaemia | 8 |
| Metabolic disorder | 1 |
| Hyperphosphatasaemia | 1 |
| Decreased appetite | 1 |
| Hyperlipidaemia | 59 |
| Musculoskeletal and connective tissue disorders | 3 (0.48) |
| Myalgia | 1 |
| Osteonecrosis | 1 |
| Osteoporosis | 1 |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 2 (0.32) |
| Kaposi's sarcoma | 1 |
| Castleman's disease | 1 |
| Metastatic gastric cancer | 1 |
| Nervous system disorders | 8 (1.28) |
| Cerebral infarction | 1 |
| Disturbance in attention | 1 |
| Dizziness | 2 |
| Dysgeusia | 1 |
| Headache | 2 |
| Tremor | 1 |
| Psychiatric disorders | 8 (1.28) |
| Depressed mood | 1 |
| Depression | 3 |
| Initial insomnia | 1 |
| Insomnia | 3 |
| Abnormal behaviour | 1 |
| Renal and urinary disorders | 5 (0.8) |
| Calculus urinary | 1 |
| Nephrolithiasis | 1 |
| Renal impairment | 3 |
| Respiratory, thoracic, and mediastinal disorders | 2 (0.32) |
| Cough | 1 |
| Dyspnoea | 1 |
| Skin and subcutaneous tissue disorders | 25 (4.01) |
| Dermatitis | 1 |
| Drug eruption | 5 |
| Erythema nodosum | 1 |
| Pruritus | 2 |
| Rash | 14 |
| Rash generalized | 1 |
| Seborrhoeic dermatitis | 1 |
| Facial wasting | 1 |
| Vascular disorders | 5 (0.80) |
| Hypertension | 5 |
†
The terms are based on MedDRA version 13.1.