Taxotere Side Effects

Generic name: docetaxel

Medically reviewed by Drugs.com. Last updated on Apr 29, 2024.

Note: This document provides detailed information about Taxotere Side Effects associated with docetaxel. Some dosage forms listed on this page may not apply specifically to the brand name Taxotere.

Applies to docetaxel: intravenous solution.

Important warnings This medicine can cause some serious health issues

Intravenous route (solution)

Warning: Toxic Deaths, Hepatoxicity, Neutropenia, Hypersensitivity Reactions, and Fluid Retention. Treatment-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 side effects

• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• burning, tingling, numbness, or pain in the hands, arms, feet, or legs
• chest pain or tightness
• chills
• cough
• decrease in the amount of urine
• diarrhea
• difficulty in swallowing
• difficulty moving
• dizziness
• dry eyes
• fainting
• fast, slow, or irregular heartbeat
• fever
• heartburn
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• lower back or side pain
• muscle pain, cramps, or stiffness
• noisy, rattling breathing
• nosebleeds
• pain or burning feeling in the throat
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• redness of the skin
• sensation of pins and needles
• severe lack or loss of strength
• sore throat
• sores, ulcers, or white spots on the lips or tongue or inside the mouth
• stabbing pain
• swelling of the eyelids, face, lips, hands, or feet
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• weight gain

Less common side effects

• bluish color of the skin
• blurred vision
• burning or itching of the eyes
• changes in skin color
• chest discomfort
• confusion
• constipation
• discharge, excessive tearing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• lightheadedness
• nausea
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• rapid, shallow breathing
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• severe stomach pain
• sweating
• vomiting of blood or material that looks like coffee grounds

Rare side effects

• dilated neck veins
• extreme tiredness or weakness
• fast, pounding, or irregular heartbeat or pulse
• headache
• irregular breathing
• nervousness
• pounding in the ears

Incidence not known

• agitation
• dark urine
• decreased awareness or responsiveness
• depression
• drowsiness
• dry mouth
• general feeling of tiredness or weakness
• hostility
• increased thirst
• indigestion
• light-colored stools
• loss of appetite
• loss of consciousness
• mood or mental changes
• muscle spasms (tetany) or twitching seizures
• nausea
• rapid, shallow breathing
• rectal bleeding
• seizures
• severe abdominal pain, cramping, or burning
• severe sleepiness
• stomach cramps, pain, or tenderness
• stomach pain, continuing
• tremor
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting of material that looks like coffee grounds, severe and continuing
• yellow eyes or skin

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 side effects

• absent, missed, or irregular menstrual periods
• bad, unusual or unpleasant (after)taste
• change in sense of smell
• change in taste
• discoloration of the fingernails or toenails
• dry skin
• loss or thinning of the hair
• stopping of menstrual bleeding
• swelling or inflammation of the mouth
• weight loss

Less common side effects

• dry, red, hot, or irritated skin

Incidence not known

• hearing loss
• pain and redness of the skin at the place of earlier radiation treatment

For healthcare professionals

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

General adverse events

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

• 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]

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]

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

• 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]

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]

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

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

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]

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

• 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]

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]

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

• 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]

Infusion reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation, or 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]

Further information

Taxotere side effects can vary depending on the individual. 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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