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Taxotere Side Effects

Generic name: docetaxel

Medically reviewed by Drugs.com. Last updated on Jul 8, 2023.

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

Applies to docetaxel: intravenous solution.

Warning

Intravenous route (Solution)

Warning: Toxic Deaths, Hepatoxicity, Neutropenia, Hypersensitivity Reactions, and Fluid RetentionTreatment-related mortality associated with docetaxel is increased in patients with abnormal liver function, in patients receiving higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based chemotherapy who receive docetaxel as a single agent at a dose of 100 mg/m(2).Avoid the use of docetaxel in patients with bilirubin greater than the ULN, or to patients with AST and/or ALT greater than 1.5 times ULN concomitant with alkaline phosphatase greater than 2.5 times ULN. Patients with elevations of bilirubin or abnormalities of transaminase concurrent with alkaline phosphatase are at increased risk for the development of severe neutropenia, febrile neutropenia, infections, severe thrombocytopenia, severe stomatitis, severe skin toxicity, and toxic death. Patients with isolated elevations of transaminase greater than 1.5 times ULN also had a higher rate of febrile neutropenia. Measure bilirubin, AST or ALT, and alkaline phosphatase prior to each cycle of docetaxel.Do not administer docetaxel to patients with neutrophil counts of less than 1500 cells/mm(3). Monitor blood counts frequently as neutropenia may be severe and result in infection.Do not administer docetaxel to patients who have a history of severe hypersensitivity reactions to docetaxel or to other drugs formulated with polysorbate 80. Severe hypersensitivity reactions have been reported in patients despite dexamethasone premedication. Hypersensitivity reactions require immediate discontinuation of the docetaxel infusion and administration of appropriate therapy.Severe fluid retention occurred in 6.5% (6/92) of patients despite use of dexamethasone premedication. It was characterized by one or more of the following events: poorly tolerated peripheral edema, generalized edema, pleural effusion requiring urgent drainage, dyspnea at rest, cardiac tamponade, or pronounced abdominal distention (due to ascites).

Serious side effects of Taxotere

Along with its needed effects, docetaxel (the active ingredient contained in Taxotere) 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 docetaxel:

More common

Less common

Rare

Incidence not known

Other side effects of Taxotere

Some side effects of docetaxel 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

Incidence not known

For Healthcare Professionals

Applies to docetaxel: intravenous powder for injection, intravenous solution.

General

The most common adverse reactions across all indications include infections, neutropenia, anemia, febrile neutropenia, hypersensitivity, thrombocytopenia, neuropathy, dysgeusia, dyspnea, constipation, anorexia, nail disorders, fluid retention, asthenia, pain, nausea, diarrhea, vomiting, mucositis, alopecia, skin reactions, and myalgia.[Ref]

Hematologic

Very common (10% or more): Neutropenia (99%), leukopenia (99%), thrombocytopenia (39%), anemia (94%)

Common (1% to 10%): Hemorrhage

Postmarketing reports: Bleeding episodes, disseminated intravascular coagulation (DIC)[Ref]

The major dose-limiting toxicity of this drug is reversible marrow suppression. In clinical trials, the median time to nadir was 7 days, and the median duration of severe neutropenia (less than 500 cells/mm3) was 7 days.

Hematologic toxicity is increased at higher doses and in patients with elevated baseline liver function tests.[Ref]

Hypersensitivity

Severe hypersensitivity reactions have been reported. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, or chills have been reported and after discontinuation of the infusion and instituting treatment as necessary, have resolved.[Ref]

Very common (10% or more): Hypersensitivity (33%)

Common (1% to 10%): Severe hypersensitivity

Frequency not reported: Flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever, chills

Postmarketing reports: Anaphylactic shock[Ref]

Cardiovascular

Very common (10% or more): Fluid retention (60%)

Common (1% to 10%): Severe fluid retention, hypotension, lymphedema, phlebitis, hypertension

Rare (less than 0.1%): Heart failure, sinus tachycardia, atrial flutter, dysrhythmia, unstable angina, pulmonary edema

Postmarketing reports: Atrial fibrillation, deep vein thrombosis, ECG abnormalities, pulmonary embolism, syncope, tachycardia, myocardial infarction, chest pain[Ref]

Dermatologic

Cutaneous reactions including severe skin toxicity has been reported. Reversible cutaneous reactions include rash mainly on the feet and/or hands, or on the arms, face, or thorax. This is usually accompanied by pruritus. Eruptions generally occur within 1 week of receiving the drug and resolve before the next infusion.[Ref]

Very common (10% or more): Alopecia (98%), cutaneous reactions (54%), nail changes (41%)

Common (1% to 10%): Severe cutaneous reactions, severe nail changes, rash

Rare (less than 0.1%): Onycholysis

Postmarketing reports: Very rare cases of cutaneous lupus erythematosus, rare cases of bullous eruptions such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and Scleroderma-like changes usually preceded by peripheral lymphedema, severe hand and foot syndrome, radiation recall[Ref]

Nervous system

Very common (10% or more): Neurosensory events (58%), dizziness (16%), headache, hypoesthesia

Common (1% to 10%): Severe neurosensory events

Uncommon (0.1% to 1%): Somnolence

Frequency not reported: Paresthesia, dysesthesia, neuromotor weakness,

Postmarketing reports: Confusion, seizures or transient loss of consciousness[Ref]

Oncologic

The cumulative risk of developing treatment-related acute myeloid leukemia appears to be similar to the risk observed for other anthracyclines/cyclophosphamide containing adjuvant breast chemotherapy regimens.[Ref]

Postmarketing reports: Acute myeloid leukemia, myelodysplasic syndrome[Ref]

Hepatic

Very common (10% or more): Transaminase elevations, (19%)

Common (1% to 10%): Bilirubin elevations, alkaline phosphatase elevations, transaminase elevations in combination with alkaline phosphatase elevations

Postmarketing reports: Hepatitis[Ref]

Among patients with normal liver function tests at baseline, elevations in bilirubin occurred in 8.9%, increases in AST or ALT to greater than 1.5 times the upper limit of normal (1.5 x ULN), or increases in alkaline phosphatase to greater than 2.5 x ULN occurred in 18.9% and 7.3%, respectively. Increases in AST and/or ALT to greater than 1.5 x ULN concurrently with alkaline phosphatase elevations to greater than 2.5 x ULN occurred in 4.3% of patients. It is unknown whether these changes were drug related or related to the underlying disease condition.[Ref]

Gastrointestinal

Considering all tumor types, stomatitis has been reported in 42% of patients with normal LFTs at baseline and 49% of patients with elevated LFTs. Severe stomatitis has been reported in 6% of patients with normal LFTs at baseline and 13% of patients with elevated LFTs. Stomatitis appears to be dose dependent.[Ref]

Very common (10% or more): Stomatitis (52%), nausea (42%), vomiting (23%), diarrhea (43%), constipation (25%), esophagitis/dysphagia/odynophagia (16%)

Common (1% to 10%): Severe gastrointestinal events, severe stomatitis, gastrointestinal pain and cramping, dry mouth

Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, severe abdominal pain, severe esophagitis

Postmarketing reports: Duodenal ulcer, gastrointestinal hemorrhage, gastrointestinal perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis, dehydration[Ref]

Other

Very common (10% or more): Asthenia (up to 66%), severe asthenia (up to 25%), febrile neutropenia (up to 26%), fever in absence of infection (up to 47%)

Common (1% to 10%): Non-septic death, impaired hearing

Postmarketing reports: Ototoxicity, hearing disorders[Ref]

Local

Infusion reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or swelling of the vein.[Ref]

Common (1% to 10%): Infusion site reactions

Frequency not reported: Hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, swelling of the vein[Ref]

Ocular

Very common (10% or more): Lacrimation disorder (11%)

Common (1% to 10%): Conjunctivitis

Postmarketing reports: Cystoid macular edema, transient visual disturbances occurring during drug infusion and in association with hypersensitivity reactions (have been reversible upon discontinuation of the infusion)[Ref]

Respiratory

Very common (10% or more): Cough, rhinorrhea, pharyngolaryngeal pain

Common (1% to 10%): Epistaxis, pneumonia, dyspnea

Postmarketing reports: Acute pulmonary edema, acute respiratory distress syndrome/pneumonitis, interstitial lung disease, interstitial pneumonia, respiratory failure, and pulmonary fibrosis, rare cases of radiation pneumonitis in patients receiving concomitant radiotherapy[Ref]

Renal

Postmarketing reports: Renal insufficiency and renal failure (majority of these cases associated with concomitant nephrotoxic drugs)[Ref]

Metabolic

Very common (10% or more): Weight gain (15%), weight loss (21%)

Common (1% to 10%): Anorexia

Postmarketing reports: Hyponatremia[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (33%)

Common (1% to 10%): Severe myalgia, arthralgia, bone pain, back pain[Ref]

Immunologic

Very common (10% or more): Infections (33%)

Common (1% to 10%): Severe infections, septic death, oral candidiasis[Ref]

Psychiatric

Very common (10% or more): Insomnia[Ref]

Endocrine

Very common (10% or more): Amenorrhea (62%)

Common (1% to 10%): Menstrual irregularities[Ref]

References

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

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Docetaxel (docetaxel). Hospira Inc. 2018.

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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