Note: This document contains side effect information about paclitaxel. Some dosage forms listed on this page may not apply to the brand name Taxol.

Applies to paclitaxel: intravenous solution.

Serious side effects of Taxol

Along with its needed effects, paclitaxel (the active ingredient contained in Taxol) 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 paclitaxel:

More common

• Black or tarry stools
• blurred vision
• burning, numbness, tingling, or painful sensations
• confusion
• cough or hoarseness with fever or chills
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• feeling of warmth
• fever or chills
• lower back or side pain
• painful or difficult urination
• pale skin
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• skin rash or itching
• sore throat
• sweating
• troubled breathing with exertion
• ulcers, sores, or white spots in the mouth
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• weakness in the arms, hands, legs, or feet

Less common

• Blood in the urine or stools
• difficult or labored breathing
• pinpoint red spots on the skin
• shortness of breath (severe)
• slow heartbeat
• tightness in the chest
• wheezing

Incidence not known

• Anxiety
• blue lips, fingernails, or skin
• difficult or troubled breathing
• fainting
• fast heartbeat
• irregular, fast or slow, or shallow breathing
• sudden shortness of breath

Other side effects of Taxol

Some side effects of paclitaxel 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

• 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
• cracked lips
• diarrhea
• difficulty with swallowing
• hair loss
• nausea or vomiting
• numbness, burning, or tingling in the hands or feet
• pain in the joints or muscles, especially in the arms or legs
• thinning of the hair

For Healthcare Professionals

Applies to paclitaxel: intravenous solution.

Cardiovascular

Very common (10% or more): Hypotension

Common (1% to 10%): Bradycardia

Uncommon (0.1% to 1%): Cardiomyopathy, asymptomatic ventricular tachycardia, tachycardia with bigeminy, atrioventricular block and syncope, myocardial infarction, hypertension, thrombosis, thrombophlebitis

Rare (0.01% to 0.1%): Cardiac failure

Very rare (less than 0.01%): Atrial fibrillation, supraventricular tachycardia, shock

Frequency not reported: Phlebitis^[Ref]

Dermatologic

Very common (10% or more): Alopecia (90%), rash

Common (1% to 10%): Transient and mild nail and skin changes, discoloration of the nail bed

Rare (0.01% to 0.1%): Pruritus, rash, erythema

Very rare (less than 0.01%): Stevens-Johnson syndrome, toxic epidermal necrolysis (TEN), erythema multiforme, exfoliative dermatitis, urticaria, onycholysis (patients on therapy should wear sun protection on hands and feet), scleroderma-like reaction^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (52%), mucositis (31%), vomiting, diarrhea mucosal inflammation

Rare (less than 0.1%): Peritonitis, bowel obstruction, bowel perforation, ischemic colitis, pancreatitis

Very rare (less than 0.01%): Pseudomembranous colitis, mesenteric thrombosis, neutropenic colitis, esophagitis, constipation, ascites^[Ref]

Hematologic

Very common (10% or more): Myelosuppression, neutropenia (90%), anemia, thrombocytopenia, leucopenia, bleeding

Rare (less than 0.1%): Febrile neutropenia^[Ref]

Hepatic

Very common (10% or more): Elevated alkaline phosphatase (22%), elevated AST (SGOT) (19%)

Common (1% to 10%): Elevated bilirubin

Very rare (less than 0.01%): Hepatic necrosis, hepatic encephalopathy (both with reported cases of fatal outcome)^[Ref]

Hypersensitivity

Very common (10% or more): Minor hypersensitivity reactions (mainly flushing and rash)

Uncommon (0.1% to 1%): Significant hypersensitivity reactions requiring therapy (e.g., hypotension, angioneurotic edema, respiratory distress, generalized urticaria, chills, back pain, chest pain, tachycardia, abdominal pain, pain in extremity, diaphoresis, hypertension)

Rare (less than 0.1%): Anaphylactic reactions

Very rare (less than 0.01%): Anaphylactic shock^[Ref]

Immunologic

Very common (10% or more): Infections (mainly urinary tract and upper respiratory tract infections), with reported cases of fatal outcome

Uncommon (0.1% to 1%): Septic shock

Rare (less than 0.1%): Sepsis, pseudomembranous colitis^[Ref]

Local

Common (1% to 10%): Injection site reactions (including localized edema, pain, erythema, induration, on occasion extravasation can result in cellulitis, skin fibrosis and skin necrosis)

Rare (less than 0.1%): Phlebitis^[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia/myalgia (44%)

Frequency not reported: Systemic lupus erythematosus, scleroderma^[Ref]

Metabolic

Common (1% to 10%): Severe elevation in aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)), severe elevation in alkaline phosphatase

Uncommon (0.1% to 1%): Severe elevation in bilirubin

Rare (0.01% to 0.1%): Dehydration, increased blood creatinine

Very rare (less than 0.01%): Anorexia

Frequency not reported: Tumor lysis syndrome^[Ref]

Nervous system

Very common (10% or more): Neurotoxicity (mainly peripheral neuropathy)

Rare (0.01% to 0.1%): Motor neuropathy (with resultant minor distal weakness)

Very rare (less than 0.01%): Autonomic neuropathy (resulting in paralytic ileus and orthostatic hypotension), optic nerve disturbance, grand mal seizures, convulsions, encephalopathy, dizziness, headache, ataxia^[Ref]

Ocular

Very rare (less than 0.01%): Optic nerve and/or visual disturbances (scintillating scotomata), particularly in patients who have received higher doses than recommended

Frequency not reported: Macular edema, photopsia, vitreous floaters^[Ref]

Oncologic

Very rare (less than 0.01%): Acute myeloid leukemia, myelodysplastic syndrome^[Ref]

Other

Rare (0.01% to 0.1%): Asthenia, pyrexia, edema, malaise

Very rare (less than 0.01%): Ototoxicity, hearing loss, tinnitus, vertigo^[Ref]

Psychiatric

Very rare (less than 0.01%): Confusional state^[Ref]

Respiratory

Rare (0.01% to 0.1%): Pneumonia, dyspnea, pleural effusion, interstitial pneumonia, lung fibrosis, pulmonary embolism, respiratory failure

Frequency not reported: Bronchospasm

Very rare (less than 0.01%): Cough^[Ref]