Adrim Adverse Reactions

The following adverse reactions are discussed in more detail in the Precautions and Warnings section: Cardiomyopathy and arrhythmias; secondary malignancies; extravasation and tissue necrosis; severe myelosuppression; tumor lysis syndrome; radiation sensitization and radiation recall.
Clinical Trial Experience in Breast Cancer: 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 data below were collected from women who received doxorubicin hydrochloride at a of 60 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 3 weeks for 4 cycles for the adjuvant treatment of axillary lymph node positive breast cancer. The median number of cycles received was 4. Selected adverse reactions reported in this study are provided in the table as follows. No treatment-related deaths were reported in patients on either arm of the study. (See Table 2.)

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Other Adverse Reactions: Cardiac: Cardiogenic shock.
Cutaneous: Skin and nail hyperpigmentation, onycholysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia.
Gastrointestinal: Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa.
Hypersensitivity: Anaphylaxis.
Laboratory Abnormalities: Increased alanine aminotransferase, increased aspartate aminotransferase.
Neurological: Peripheral sensory and motor neuropathy, seizures, coma.
Ocular: Conjunctivitis, keratitis, lacrimation.
Vascular: Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism.
Other: Malaise/asthenia, fever, chills, weight gain.