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Paclitaxel Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 5, 2023.

Applies to paclitaxel: intravenous solution.

Warning

Intravenous route (Solution)

Anaphylaxis and severe hypersensitivity reactions characterized by dyspnea and hypotension requiring treatment, angioedema, and generalized urticaria have occurred in clinical trials. Fatal reactions have occurred in patients despite premedication, and all patients should be pretreated with corticosteroids, diphenhydramine, and H2 antagonists. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Paclitaxel therapy should not be given to patients with solid tumors who have baseline neutrophil counts of less than 1500 cells/mm(3) and should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline neutrophil count is less than 1000 cells/mm(3). Monitor peripheral blood cell counts frequently.

Serious side effects of Paclitaxel

Along with its needed effects, paclitaxel 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

Less common

Incidence not known

Other side effects of Paclitaxel

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

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]

Frequently asked questions

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Paclitaxel (paclitaxel). Sandoz Pharmaceuticals Corporation. 2016.

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.