Clinical Trial Adverse Drug Reactions
Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates.
The following adverse reactions in the male have occurred with some androgens:
| MedDRA System Organ Class (SOC) | Adverse Drug Reaction |
| Blood and the lymphatic system disorders: | Suppression of clotting factors II, V, VII, and X, bleeding in patients on concomitant anticoagulant therapy, and polycythemia. |
| Cardiovascular disorders: | Myocardial infarction, stroke |
| Gastrointestinal disorders: | Nausea |
| General disorders and administration site conditions: | Inflammation and pain at the site of intramuscular injection. |
| Hepatobiliary disorders: | Cholestatic jaundice, alterations in liver function tests, hepatocellular neoplasms and peliosis hepatis |
| Immune system disorders: | Hypersensitivity, including skin manifestations and anaphylactoid reactions. |
| Metabolism and nutrition disorders: | Retention of sodium, chloride, water, potassium, calcium, and inorganic phosphates. |
| Nervous system disorders: | Increased or decreased libido, headache, anxiety, depression, and generalized paresthesia. |
| Reproductive system and breast disorders: | Gynecomastia, excessive frequency and duration of penile erections, and oligospermia. |
| Skin and subcutaneous tissue disorders: | Hirsutism, male pattern of baldness, seborrhea, and acne. |
Post-Market Adverse Drug Reactions
The following adverse reactions have been identified during post-marketing use of testosterone replacement therapy in general. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
| MedDRA System Organ Class (SOC) | Adverse Drug Reaction |
| Blood and the lymphatic system disorders: | Erythropoiesis abnormal |
| Cardiovascular disorders: | Tachycardia, atrial fibrillation, pulmonary embolism, and deep vein thrombosis |
| Endocrine disorders: | Abnormal accelerated growth |
| Eye disorders: | Chorioretinopathy |
| Gastrointestinal disorders: | Vomiting, diarrhea, abdominal pain, gastrointestinal bleeding |
| General disorders and administration site conditions: | Edema, malaise, fatigue, application site burning, application site induration, application site rash, application site dermatitis, application site blister, application site erythema |
| Investigations: | Weight increase, fluctuating testosterone levels, testosterone decreased, lipids abnormalities |
| Metabolism and nutrition disorders: | Increased appetite, urine calcium decrease, glucose tolerance impaired, elevated cholesterol |
| Musculoskeletal and connective tissue disorders: | Myalgia, arthralgia |
| Nervous system disorders: | Insomnia, headache, dizziness |
| Psychiatric disorders: | Personality disorder, confusion, anger, aggression, cognitive disturbance |
| Renal and urinary disorders: | Dysuria, hematuria, incontinence, bladder irritability |
| Reproductive system and breast disorders: | Prostate carcinoma, enlarged prostate (benign), free prostate-specific antigen increased, testicular atrophy, epdidymitis, priapism, impotence, precocious puberty, mastodynia |
| Respiratory, thoracic and mediastinal disorders: | Dyspnea, sleep apnea |
| Skin and subcutaneous tissue disorders: | Pruritus, rash, urticaria, vesiculo-bullous rash, alopecia |
| Vascular disorders: | Hypertension |