Navelbine Side Effects

Generic Name: vinorelbine

Please note - some side effects for Navelbine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Navelbine - for the Consumer

Navelbine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Navelbine:

Diarrhea; hair loss; nausea; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; constipation; cough; numbness or tingling of your fingers or toes; pain, redness, or swelling at the injection site; shortness of breath; stomach pain; unusual bleeding or bruising.

Side Effects by Body System

Hematologic

Pulmonary embolus and deep venous thrombosis have primarily been reported in seriously ill and debilitated patients with known predisposing risk factors for these events.

Hematologic side effects have included granulocytopenia, which has been the major dose-limiting toxicity with the use of vinorelbine. Granulocytopenia has been reported at a frequency of 90% of patients with less than 2,000 cells/mm3 and 36% of patients with less than 500 cells/mm3. Leukopenia has been reported at a frequency of 92% of patients with less than 4,000 cells/mm3 and 5% of patients with less than 1,000 cells/mm3. Thrombocytopenia has been reported at a frequency of 5% of patients with less than 100,000 cells/mm3 and 1% of patients with less than 50,000 cells/mm3. And finally, anemia has been reported at a frequency of 83% of patients with less than 11 g/dL and 9% of patients with less than 8 g/dL. Pulmonary embolus and deep venous thrombosis have also been reported.

Hepatic

Hepatic side effects including an increase in SGOT (67%) and an increase in total bilirubin (13%) have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea (44%), constipation (35%), vomiting (20%), diarrhea (17%), dysphagia, and mucositis have been reported. A case of typhlitis (neutropenic enterocolitis) has also been reported.

General

General side effects including asthenia (36%), fatigue (27%), back pain, abdominal pain, and pain in tumor containing tissues have been reported.

Fatigue was usually mild or moderate and tended to increase with increased cumulative dosing.

Local

Local side effects including injection site reactions (28%) and injection site pain (16%) have been reported.

Nervous system

Nervous system side effects including peripheral neuropathy (paresthesia and hypesthesia) (25%) and headache have been reported.

Dermatologic

Some of these dermatologic reactions have been delayed in their occurrence.

Dermatologic side effects including alopecia (12%), rash (<5%), pruritus, blister formation, skin sloughing, and urticaria have been reported.

Cardiovascular

Most of the chest pain has been reported to have occurred in patients who had either a history of cardiovascular disease or tumor within the chest.

Cardiovascular side effects including phlebitis (7%), chest pain (5%), myocardial infarction, angioedema, hypertension, hypotension, vasodilation, tachycardia, and flushing have been reported.

Respiratory

Respiratory side effects including dyspnea (7%), shortness of breath (3%), severe shortness of breath (2%), pulmonary edema, and pneumonia have been reported.

Musculoskeletal

Musculoskeletal side effects including jaw pain, myalgia, and arthralgia have been reported in less than 5% of patients.

Genitourinary

Genitourinary side effects including hemorrhagic cystitis (<1%) have been reported.

Metabolic

Metabolic side effects including the syndrome of inappropriate antidiuretic hormone (<1%) have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

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