Atgam Adverse Reactions

The most clinically significant adverse reactions are anaphylaxis, infection, thrombocytopenia, leukopenia, arthralgia, edema, bradycardia, and abnormal renal and liver function tests.
Clinical Trials Experience: Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety of ATGAM has been evaluated in 367 patients with renal allograft rejection and 109 patients with aplastic anemia.
The renal allograft rejection and aplastic anemia patients received a similar dosing regimen, and these data were pooled to obtain the frequencies listed in Tables 2 and 3 as follows.
The most commonly reported adverse reactions (occurring in greater than 10% of patients) are pyrexia, chills, rash, thrombocytopenia, leukopenia and arthralgia. (See Tables 2 and 3.)

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Click on icon to see table/diagram/image

Post-marketing Experience: The following adverse reactions have been identified during post-approval use of ATGAM. 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.
Infections and infestations: Sepsis, Hepatitis viral, Localized infection, Systemic infection (bacterial, viral, fungal).
Blood and lymphatic system disorders: Anemia, Eosinophilia, Granulocytopenia, Hemolysis, Hemolytic anemia, Neutropenia, Pancytopenia.
Psychiatric disorders: Confusional state, Disorientation.
Nervous system disorders: Dyskinesia, Syncope, Tremor.
Cardiac disorders: Cardiac failure congestive.
Vascular disorders: Deep vein thrombosis, Vasculitis.
Respiratory, thoracic and mediastinal disorders: Apnea, Cough, Epistaxis, Oropharyngeal pain.
Gastrointestinal disorders: Abdominal pain, Gastrointestinal hemorrhage, Gastrointestinal perforation, Oral pain.
Skin and subcutaneous tissue disorders: Hyperhidrosis.
Musculoskeletal and connective tissue disorders: Flank pain, Muscle rigidity, Myalgia, Pain in extremity.
Renal and urinary disorders: Kidney enlargement, Kidney rupture, Renal failure acute.
Congenital, familial and genetic disorders: Aplasia.
General disorders and administration site conditions: Infusion site erythema, Infusion site swelling, Pain.