Taxotere Side Effects
Generic name: docetaxel
Medically reviewed by Drugs.com. Last updated on Oct 17, 2022.
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)
Treatment-related mortality increases with abnormal liver function, at higher doses, and in patients with non-small cell lung carcinoma and a history of prior treatment with platinum-based therapy receiving docetaxel at 100 mg/m(2). Avoid use in patients with bilirubin greater than the ULN, or AST or ALT greater than 1.5 x ULN concomitant with alkaline phosphatase greater than 2.5 x ULN; these patients are at increased risk for developing severe or life-threatening toxicities. Obtain LFTs prior to each treatment cycle. Do not use patients with neutrophil counts of less than 1500 cells/mm(3); obtain frequent blood counts to monitor for neutropenia. Severe hypersensitivity, including fatal anaphylaxis, has been reported in patients who received dexamethasone premedication. Severe reactions require immediate docetaxel discontinuation. Use is contraindicated in patients with a severe hypersensitivity to docetaxel or polysorbate 80. Severe fluid retention may occur despite dexamethasone.
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
- 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
- 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
- tightness in the chest
- trouble breathing
- troubled breathing at rest
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- vomiting
- weight gain
Less common
- 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
- 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
- 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 hair loss or thinning of hair
- stopping of menstrual bleeding
- swelling or inflammation of the mouth
- weight loss
Less common
- 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
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]
More about Taxotere (docetaxel)
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- Drug class: mitotic inhibitors
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
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.