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.

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 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

• 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
• loss or thinning of the 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]