BiCNU Adverse Reactions

The following serious adverse reactions are described elsewhere in the labeling: Myelosuppression [see Precautions]; Pulmonary toxicity [see Precautions]; Administration Reactions [see Precautions]; Carcinogenicity [see Precautions]; Ocular Toxicity [see Precautions].
The following adverse reactions associated with the use of BiCNU were identified in clinical studies or postmarketing reports. Because some of these reactions were 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.
Cardiac Disorders: Tachycardia and chest pain.
Eye Disorders: Conjunctival edema, conjunctival hemorrhage, blurred vision and loss of depth perception.
Gastrointestinal Toxicity: Nausea, vomiting, anorexia, and diarrhea.
Hepatotoxicity: Increased transaminase, increased alkaline phosphatase, increased bilirubin levels.
Infections and Infestations: Opportunistic infection (including with fatal outcome).
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps): Acute leukemia, bone marrow dysplasias.
Nephrotoxicity: Progressive azotemia, decrease in kidney size, renal failure.
Nervous System Disorders: Headaches, encephalopathy, and seizures.
Pulmonary Toxicity: Pneumonitis, interstitial lung disease.
Reproductive System and Breast Disorders: Gynecomastia.
Skin and Subcutaneous Tissue Disorders: Burning sensation, hyperpigmentation, swelling, pain, erythema, skin necrosis, alopecia, allergic reaction.
Vascular Disorders: Veno-occlusive disease.