Taxol Side Effects

Generic name: paclitaxel

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

Some side effects of Taxol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to paclitaxel: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking paclitaxel (the active ingredient contained in Taxol) hives; difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• flushing (warmth, redness, or tingly feeling);

• slow heart rate, feeling like you might pass out;

• seizure (convulsions);

• chest pain, dry cough, wheezing, feeling short of breath;

• numbness, tingling, or burning pain in your hands or feet;

• jaundice (yellowing of the skin or eyes); or

• severe redness or swelling, severe irritation, a hard lump, or skin changes where the injection was given.

Common side effects may include:

• mild nausea, vomiting, diarrhea, constipation;

• weakness;

• joint or muscle pain;

• darkening of your skin or nails; or

• temporary hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to paclitaxel: intravenous solution

Hematologic

Hematologic side effects including bone marrow suppression have been the major dose-limiting toxicity. Neutropenia less than 2,000 cells/mm3 (90%) and less than 500 cells/mm3 (52%), is the most important hematological toxicity. Neutropenia has been both dose and schedule dependent, and generally rapidly reversible. The onset of neutropenia generally occurs after 8 to 10 days and recovery generally occurs after 15 to 21 days. Neutropenia does not appear to increase with cumulative exposure, nor to be more frequent or severe for patients previously treated with radiation therapy. Leukopenia less than 4,000 cells/mm3 (90%) and less than 1,000 cells/mm3 (17%), thrombocytopenia less than 100,000 cells/mm3 (20%) and less than 50,000 cells/mm3 (7%), and anemia less than 11 g/dl (78%) and less than 8 g/dl (16%) have been reported. Infections (30%), bleeding (14%), red cell transfusions (25%) and platelet transfusions (2%) have been reported. A case of paclitaxel-induced sickle cell crisis has also been reported.

Fever (12% of all treatment courses) has been reported. Fatal infectious episodes (1%) including sepsis, pneumonia and peritonitis have been reported.

Bleeding episodes (4% of all courses and 14% of all patients) have been reported. Most of the episodes were localized.

Hypersensitivity

Hypersensitivity side effects (41%) including severe reactions (2%) have been reported. The most frequent symptoms observed during the severe reactions were dyspnea, flushing, chest pain, and tachycardia. Minor hypersensitivity reactions consisted mostly of flushing (28%), rash (12%), hypotension (4%), dyspnea (2%), tachycardia (2%), and hypertension (1%). Three patients with transient pulmonary infiltrates caused by hypersensitivity reactions (after receiving treatment with paclitaxel (the active ingredient contained in Taxol) and carboplatin) have been reported. A case of pneumonitis responsive to high-dose corticosteroids and a case of bullous fixed drug eruption have also been reported.

The frequency and severity of hypersensitivity reactions were not affected by the dose or schedule of administration. Severe symptoms have primarily been reported to occur within the first hour of the infusion.

Single dose intravenous dexamethasone can be used in combination with appropriated ancillary medications to prevent paclitaxel-related hypersensitivity reactions.

Cardiovascular

The manufacturer further states that abnormal ECG readings have been reported in 23% of all patients receiving paclitaxel (the active ingredient contained in Taxol) and in 14% of the patients with normal baseline ECGs. The most frequently reported ECG modifications were nonspecific repolarization abnormalities, sinus bradycardia, sinus tachycardia and premature beats.

Cardiovascular side effects have included vital sign changes including bradycardia (3%) and hypotension (12%) during the first 3 hours of infusion as stated by the manufacturer. Significant cardiovascular events (1%) including syncope, rhythm abnormalities, hypertension and venous thrombosis have also been reported. A report from the Johns Hopkins oncology center stated that asymptomatic sinus bradycardia occurred in up to 29% of patients in phase 2 trails, and that other cardiac disturbances including atrioventricular conduction and bundle branch blocks, ventricular tachycardia, and possible ischemic manifestations had been reported (3%). A case of fatal myocardial infarction potentially induced by paclitaxel has also been reported.

Nervous system

Nervous system side effects including neurotoxicity, primarily including peripheral neurosensory manifestations (60%), have generally been mild to moderate in severity. However, severe symptoms (3%) have also been reported. Other serious neurologic events (less than 1%) have been reported including grand mal seizures, syncope, ataxia, neuroencephalopathy and autonomic neuropathy resulting in paralytic ileus. Disturbances of the optic nerve (19%) have also been reported.

The frequency and severity of neurologic manifestations have been dose dependent and cumulative. One study found that although the neurotoxicity was frequent, it remained mild or subclinical up to at least 1400 mg/m2 administered over 8 cycles.

Peripheral neuropathy may appear within 24 to 72 hours when high doses are administered. The frequency of peripheral neuropathy also has been reported to have increased with cumulative dose. It usually presents as a "stocking-and-glove" numbness and paresthesia.

At least 3 cases of phantom limb pain associated with paclitaxel use have been reported.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting (52%), diarrhea (38%) and mucositis (31%) have been reported. Intestinal obstruction, intestinal perforation and ischemic colitis have been reported rarely. Three cases of pancreatitis have also been reported.

Gastrointestinal effects can generally be treated with standard antiemetic antidiarrheal therapy and dietary changes.

Mucositis occurs most frequently in patients receiving high doses. It is schedule-dependent, occurring more frequently with 24 and 96 hour infusions.

The author of one of the case reports of pancreatitis suggested that it was the companion agent, cremophor that was the cause, rather than the paclitaxel itself.

Hepatic

Prolonged exposure to paclitaxel (the active ingredient contained in Taxol) has not been associated with cumulative hepatic toxicity.

Hepatic side effects including elevations in bilirubin (7%), alkaline phosphatase (22%) and AST (SGOT) (19%) have been reported in patients with normal baseline levels. Hepatic necrosis and hepatic encephalopathy leading to death have been reported rarely. A case of fatal hepatic coma has also been reported.

Renal

Renal side effects including edema have been reported in 21% of all patients receiving paclitaxel (the active ingredient contained in Taxol) and 17% of patients without baseline edema. Severe edema has been reported in 1% of patients.

Dermatologic

Dermatologic side effects including transient skin changes due to hypersensitivity reactions and skin abnormalities related to radiation recall have been reported. Alopecia (87%) and cumulative loss of body hair have also been reported. Some reports suggest that paclitaxel (the active ingredient contained in Taxol) may cause vesicant reactions when extravasated. Nail changes including changes in pigmentation or discoloration of the nail bed have been reported (2%). Two cases of cutaneous lupus erythematosus and one case of systemic lupus erythematosus have been reported. Two cases of scleroderma-like reactions have been reported. A case of paclitaxel administration via a central vein producing a recall reaction at a site of prior paclitaxel extravasation has also been reported. A case of severe mucocutaneous toxicity and a case of cutaneous systemic sclerosis have been reported.

Alopecia usually begins 1 to 2 weeks after treatment and is usually reversible.

Respiratory

Respiratory side effects including radiation recall pneumonitis have been reported.

Musculoskeletal

Musculoskeletal side effects including myalgia and/or arthralgia (60%), including severe symptoms (8%) have been reported.

Symptoms were usually transient, occurred two or three days after drug administration and resolved within five to seven days. Symptoms are more frequent and severe in patients receiving doses greater than 200 mg/m2.

Local

Injection site reactions, including reactions secondary to extravasation, were usually mild and consisted of erythema, tenderness, skin discoloration, or swelling at the injection site.

Local side effects have included injection site reactions. Phlebitis has been reported rarely.

Other

Other side effects including cellulitis have been reported rarely.

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