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Vinorelbine Side Effects

For the Consumer

Applies to vinorelbine: intravenous solution

Warning

Intravenous route (Solution)

Myelosuppression: Severe myelosuppression resulting in serious infection, septic shock, hospitalization and death may occur. Decrease the dose or withhold vinorelbine in accord with recommended dose modifications.

Along with its needed effects, vinorelbine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking vinorelbine:

More Common

  • Cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • lower back or side pain, accompanied by fever or chills
  • painful or difficult urination, accompanied by fever or chills
  • redness, increased warmth, pain, or discoloration of vein at place of injection
  • sore throat, accompanied by fever or chills

Less Common

  • Chest pain
  • shortness of breath
  • sores in mouth and on lips

Rare

Check with your doctor as soon as possible if any of the following side effects occur while taking vinorelbine:

More Common

  • Loss of strength and energy
  • unusual tiredness or weakness

Less Common

  • Numbness or tingling in fingers and toes

Symptoms of Overdose

  • Chest pain
  • cough or hoarseness, accompanied by fever or chills
  • fever or chills
  • heartburn
  • lower back or side pain, accompanied by fever or chills
  • mild abdominal pain and constipation
  • numbness or tingling in fingers and toes
  • painful or difficult urination, accompanied by fever or chills
  • sore throat, accompanied by fever or chills
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting

Some side effects of vinorelbine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More Common

Less Common

  • Diarrhea
  • jaw pain
  • joint or muscle pain

For Healthcare Professionals

Applies to vinorelbine: intravenous solution

Hematologic

Very common (10% or more): Neutropenia (89%), anemia (89%), leukopenia (88%), thrombocytopenia (29%)

Frequency not reported: Febrile neutropenia[Ref]

Hepatic

Very common (10% or more): AST increased (67%), bilirubin increased (13%)[Ref]

Gastrointestinal

Very common (10% or more): Nausea (44%), constipation (35%), vomiting (20%), diarrhea (17%), stomatitis (15%), abdominal pain

Common (1% to 10%): Esophagitis

Rare (less than 0.1%): Paralytic ileus, pancreatitis

Frequency not reported: GI bleeding[Ref]

Local

Very common (10% or more): Injection site reactions (e.g., erythema, burning sensation, venous discoloration, local phlebitis)

Rare (less than 0.1%): Local necrosis

Frequency not reported: Neutropenic septicemia[Ref]

Nervous system

Very common (10% or more): Peripheral neuropathy (25%), neurological alterations (e.g., loss of deep tendon reflexes)

Uncommon (0.1% to 1%): Severe paresthesia with sensory and motor symptoms[Ref]

Dermatologic

Very common (10% or more): Alopecia (12%)

Rare (less than 0.1%): Generalized skin reactions

Frequency not reported: Erythema of hands and feet

Postmarketing reports: Pruritus, urticaria[Ref]

Cardiovascular

Common (1% to 10%): Phlebitis, chest pain

Uncommon (0.1% to 1%): Hypotension, hypertension, flushing, peripheral coldness

Rare (0.01% to 0.1%): Ischemic heart disease (e.g., angina pectoris, myocardial infarction), severe hypotension, cardiovascular collapse

Very rare (less than 0.01%): Tachycardia, palpitations, altered heart rhythm

Frequency not reported: Myocardial infarction[Ref]

Respiratory

Common (1% to 10%): Dyspnea, cough

Uncommon (0.1% to 1%): Bronchospasm

Rare (less than 0.1%): Interstitial lung disease

Postmarketing reports: Pneumonia, pulmonary edema[Ref]

Musculoskeletal

Very common (10% or more): Lower limb weakness

Common (1% to 10%): Arthralgia, myalgia, pain in jaw

Rare (less than 0.1%): Severe hyponatremia[Ref]

Genitourinary

Common (1% to 10%): Dysuria[Ref]

Metabolic

Very common (10% or more): Stomatitis (15%), anorexia, weight loss

Common (1% to 10%): Weight gain

Frequency not reported: Anorexia[Ref]

Hypersensitivity

Frequency not reported: Systemic allergic reactions (e.g., anaphylaxis, anaphylactic shock, anaphylactoid reaction)

Postmarketing reports: Angioedema[Ref]

Immunologic

Common (1% to 10%): Common (1% to 10%): Bacterial, viral, or fungal infections (e.g., respiratory tract, urinary tract, GI tract)

Uncommon (0.1% to 1%): Severe sepsis, septicemia

Very rare (less than 0.01%): Complicated septicemia (sometimes fatal)[Ref]

Ocular

Common (1% to 10%): Visual disorder[Ref]

Psychiatric

Common (1% to 10%): Insomnia[Ref]

Other

Very common (10% or more): Asthenia (36%), ototoxicity (10%)

Common (1% to 10%): Fatigue, fever, pain at different sites (e.g., chest pain, pain at the site of the tumor, headache, dizziness, taste disorder

Uncommon (0.1% to 1%): Ataxia[Ref]

Endocrine

Frequency not reported: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)[Ref]

References

1. "Product Information. Navelbine (vinorelbine)." Glaxo Wellcome, Research Triangle Pk, NC.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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