Table 3.
Adverse drug reactions observed during the treatment with Ziagen† (736 events in 306 subjects)
| Adverse drug reaction | Cases (%) |
|---|---|
| Blood and lymphatic system disorders | 17 (2.6) |
| Anemia | 8 |
| Disseminated intravascular coagulation | 1 |
| Iron deficiency anemia | 1 |
| Leucopenia | 1 |
| Lymphadenopathy | 1 |
| Neutropenia | 1 |
| Pancytopenia | 2 |
| Thrombocytopenias | 1 |
| Hemorrhagic diathesis | 3 |
| Cardiac disorders | 6 (0.9) |
| Atrial fibrillation | 2 |
| Conduction disorder | 1 |
| Palpitations | 3 |
| Endocrine disorders | 1 (0.2) |
| Hypothyroidism | 1 |
| Eye disorders | 1 (0.2) |
| Conjunctival hyperemia | 1 |
| Gastrointestinal disorders | 76 (11.8) |
| Abdominal discomfort | 6 |
| Abdominal distension | 1 |
| Abdominal Pain | 3 |
| Abdominal pain upper | 3 |
| Acute abdomen | 1 |
| Ascites | 1 |
| Constipation | 1 |
| Diarrhea | 21 |
| Dyspepsia | 2 |
| Gastric ulcer | 1 |
| Gastritis | 1 |
| Gastrointestinal disorder | 2 |
| Hematochezia | 1 |
| Nausea | 40 |
| Pancreatitis acute | 3 |
| Pancreatitis relapsing | 1 |
| Stomatitis | 1 |
| Vomiting | 13 |
| Paraesthesia oral | 1 |
| General disorders and administration site conditions | 29 (4.5) |
| Asthenia | 1 |
| Chest pain | 1 |
| Fatigue | 1 |
| Feeling hot | 1 |
| Influenza like illness | 1 |
| Malaise | 11 |
| Edema | 1 |
| Pain | 1 |
| Pyrexia | 11 |
| Thirst | 1 |
| Hepatobiliary disorders | 45 (7.0) |
| Cholecystitis (acute) | 1 |
| Cholelithiasis | 1 |
| Hepatic cirrhosis | 2 |
| Hepatic failure | 1 |
| Hepatic function abnormal | 26 |
| Hepatomegaly | 1 |
| Hyperbilirubinemia | 1 |
| Jaundice | 1 |
| Liver disorder | 13 |
| Immune system disorders | 5 (0.8) |
| Drug hypersensitivity | 2 |
| Hypersensitivity | 2 |
| Immune reconstitution syndrome | 1 |
| Infections and infestations | 12 (1.9) |
| Cytomegalovirus infection | 1 |
| Hepatitis B | 2 |
| Herpes zoster | 2 |
| Nasopharyngitis | 1 |
| Pneumonia | 1 |
| Pulmonary tuberculosis | 2 |
| Sepsis | 1 |
| HIV wasting syndrome | 1 |
| Kaposi's varicelliform eruption | 1 |
| Mycobacterium avium complex infection | 1 |
| Anogenital warts | 1 |
| Injury, poisoning, and procedural complications | 1 (0.2) |
| Subdural hematoma | 1 |
| Investigations | 117(18.2) |
| Alanine amino transferase increased | 11 |
| Aspartate amino transferase increased | 8 |
| Urine β-2 microglobulin increased | 1 |
| Blood amylase increased | 3 |
| Blood bilirubin increased | 4 |
| Blood cholesterol increased | 4 |
| Blood creatine phosphokinase increased | 1 |
| Blood creatinine increased | 1 |
| Blood lactate dehydrogenase increased | 3 |
| Blood lactic acid increased | 6 |
| Blood pyruvic acid increased | 1 |
| Blood triglycerides increased | 34 |
| Blood uric acid increased | 25 |
| Cardiac murmur | 1 |
| γ-glutamyltransferase increased | 36 |
| Urine glucose present | 1 |
| Granulocyte count decreased | 1 |
| Hemoglobin decreased | 2 |
| Liver function test abnormal | 4 |
| Lymphocyte count increased | 2 |
| Neutrophil count decreased | 1 |
| Platelet count decreased | 8 |
| Red blood cell count decreased | 1 |
| Red blood cell count increased | 1 |
| Weight decreased | 1 |
| White blood cell count decreased | 10 |
| Blood alkaline phosphatase increased | 10 |
| Hepatic enzyme increased | 1 |
| Metabolism and nutrition disorders | 122 (19.0%) |
| Anorexia | 3 |
| Diabetes mellitus | 11 |
| Hypercholesterolemia | 5 |
| Hyperglycemia | 3 |
| Hyperlactacidemia | 4 |
| Hypertriglyceridemia | 17 |
| Hyperuricemia | 5 |
| Hypophosphatemia | 1 |
| Lactic acidosis | 1 |
| Fat redistribution | 1 |
| Decreased appetite | 1 |
| Hyperlipidemia | 78 |
| Hyperamylasemia | 1 |
| Musculoskeletal and connective tissue disorders | 11 (1.7) |
| Arthralgia | 2 |
| Muscular weakness | 1 |
| Myalgia | 3 |
| Osteonecrosis | 2 |
| Osteoporosis | 1 |
| Rhabdomyolysis | 1 |
| Musculoskeletal stiffness | 1 |
| Neoplasms benign, malignant, and unspecified (including cysts and polyps) | 1 (0.2) |
| Kaposi's sarcoma | 1 |
| Nervous system disorders | 48 (7.5) |
| Burning sensation | 1 |
| Cerebral hemorrhage | 2 |
| Cerebral infarction | 1 |
| Convulsion | 3 |
| Disturbance in attention | 1 |
| Dizziness | 11 |
| Dysgeusia | 2 |
| Guillain–Barre syndrome | 1 |
| Headache | 9 |
| Hyperesthesia | 1 |
| Hypoesthesia | 13 |
| Nervous system disorder | 1 |
| Neuropathy peripheral | 9 |
| Somnolence | 4 |
| Tremor | 1 |
| Facial nerve disorder | 1 |
| Psychiatric disorders | 21 (3.3) |
| Abnormal dreams | 5 |
| Depression | 4 |
| Emotional disorder | 1 |
| Insomnia | 11 |
| Mental disorder | 3 |
| Terminal insomnia | 1 |
| Renal and urinary disorders | 8 (1.2) |
| Nephrotic syndrome | 1 |
| Neurogenic bladder | 2 |
| Renal disorder | 2 |
| Renal failure acute | 1 |
| Renal failure chronic | 1 |
| Renal impairment | 5 |
| Reproductive system and breast disorders | 5 (0.8) |
| Gynecomastia | 5 |
| Respiratory, thoracic, and mediastinal disorders | 13 (2.0) |
| Asthma | 2 |
| Cough | 1 |
| Dyspnea | 4 |
| Hyperventilation | 2 |
| Interstitial lung disease | 2 |
| Pulmonary embolism | 1 |
| Upper respiratory tract inflammation | 1 |
| Skin and subcutaneous tissue disorders | 54 (8.4) |
| Drug eruption | 7 |
| Eczema | 1 |
| Erythema | 1 |
| Erythema multiforme | 1 |
| Lipoatrophy | 5 |
| Pain of skin | 1 |
| Rash | 26 |
| Rash generalized | 1 |
| Seborrheic dermatitis | 1 |
| Lipodystrophy acquired | 7 |
| Partial lipodystrophy | 1 |
| Facial wasting | 2 |
| Hypoesthesia facial | 1 |
| Vascular disorders | 11 (1.7) |
| Hypertension | 10 |
| Thromboangiitis obliterans | 1 |
| Deep vein thrombosis | 1 |
| Hemorrhage | 1 |
†
The terms are based on Medical Dictionary for Regulatory Activities version 12.0.