Applies to vinorelbine: intravenous solution.

Serious side effects of Vinorelbine

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 or nurse immediately if any of the following side effects occur while taking vinorelbine:

More common

• Black, tarry stools
• bleeding gums
• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• blood in the urine or stools
• bluish color of the skin
• burning, numbness, tingling, or painful sensations
• changes in skin color
• chest pain
• chills
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• dizziness
• feeling of fullness in the ears
• fever
• headache
• hoarseness
• itching, skin rash
• loss of appetite
• loss of balance
• loss of hearing
• lower back or side pain
• muscle pains, cramps, or stiffness
• nausea
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• ringing or buzzing in the ears
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain or tenderness
• swelling of the feet or lower legs
• swollen glands
• tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
• trouble in hearing
• troubled breathing with exertion
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• yellow eyes or skin

Less common

• Chest tightness
• increased sensitivity to pain or touch
• overactive reflexes, followed by underactive reflexes
• trouble breathing

Rare

• Agitation
• chest discomfort
• confusion
• decreased awareness or responsiveness
• decreased urine output
• depression
• frequent urination
• hostility
• irritability
• loss of consciousness
• lower abdominal cramping
• muscle twitching
• pain or discomfort in the arms, jaw, back, or neck
• rapid weight gain
• seizures
• severe sleepiness
• swelling of the face, ankles, or hands
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting

Incidence not known

• Anxiety
• blistering or sloughing of the skin
• bloating
• blurred vision
• change in walking and balance
• clumsiness or unsteadiness
• coughing that sometimes produces a pink frothy sputum
• difficult, fast, noisy breathing
• difficulty in swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, pounding, or irregular heartbeat or pulse
• heartburn
• hives or welts
• increased sweating
• increased thirst
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• nervousness
• pain or burning in the throat
• pain, redness, or swelling in the arm or leg
• pains in the stomach, side, or abdomen, possibly radiating to the back
• pale skin
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness, swelling, or pain of the skin
• scaling of the skin on the hands and feet
• slow heartbeat
• ulceration of the skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking vinorelbine:

Symptoms of overdose

• Chest pain
• chills
• confusion
• fainting
• fast heartbeat
• fever
• lightheadedness
• lower back or side pain
• painful or difficult urination
• partial or slight paralysis
• rapid, shallow breathing
• severe constipation
• severe stomach pain
• severe vomiting
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• unusual bleeding or bruising
• unusual tiredness or weakness

Other side effects of Vinorelbine

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

• Change in taste
• diarrhea
• difficulty in moving
• impaired hearing
• joint pain or swelling
• lack or loss of strength
• thinning or loss of hair

Incidence not known

• Back pain
• cracked, dry, scaly skin
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• jaw pain
• pain and redness of the skin at the place of earlier radiation treatment

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]