Taxotere Side Effects

Generic Name: docetaxel

Please note - some side effects for Taxotere may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Taxotere - for the Consumer

Taxotere

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Taxotere:

Color changes of the toenails or fingernails; constipation; diarrhea; dizziness; hair loss; increased tear production; loss of appetite; mild pain, swelling, or redness at the injection site; muscle or joint pain; nausea; numbness, tingling, pain, burning, or weakness in the hands, arms, legs, or feet; taste changes; vomiting; weakness or tiredness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; black or bloody stools; change of skin color; chest pain or tightness; decreased urination; fainting; fast, slow, or irregular heartbeat; fever, chills, or sore throat; flushing; increased or painful urination; mouth or lip sores or inflammation; red, swollen, hardened, blistered, or peeling skin; severe or persistent dizziness or headache; severe or persistent nausea, vomiting, diarrhea, or stomach pain; severe or persistent weakness or tiredness; shortness of breath; stomach swelling; sudden, unusual weight gain; swelling of the hands, feet, or ankles; swollen lymph glands; trouble swallowing; unusual bruising or bleeding; vision problems; vomit that looks like coffee grounds; warm sensation while you are receiving Taxotere; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Hematologic

Hematologic side effects including bone marrow suppression have been the major dose-limiting toxicity. A reversible and not cumulative neutropenia has also been reported. A median of 8 days to nadir and median duration of severe neutropenia (less than 500 cells/mm3) of 7 days has been reported. A fatal gastrointestinal hemorrhage associated with thrombocytopenia has been reported in one patient. Three patients with severe liver dysfunction developed fatal gastrointestinal bleeding associated with severe drug-induced thrombocytopenia. Disseminated intravascular coagulation (DIC), often in association with sepsis or multiorgan failure, has been reported during postmarketing experience.

Patients carrying the GSTP1 A/B and 3435TT genotypes may have excessive hematologic toxicity.

In a summary of 37 clinical trials (n = 1,495), neutropenia (less than 2,000 cells/mm3) has been reported in 96.3% of patients with normal LFTs at baseline and 96% of patients with elevated LFTs. Neutropenia (less than 500 cells/mm3) has been reported in 76% of patients with normal LFTs at baseline and 86% of patients with elevated LFTs.

Leukopenia (less than 4,000 cells/mm3) has been reported in 96.5% of patients with normal LFTs at baseline and 98.1% of patients with elevated LFTs. Leukopenia (less than 1,000 cells/mm3) has been reported in 31% of patients with normal LFTs at baseline and 44.2% of patients with elevated LFTs. Thrombocytopenia (less than 100,000 cells/mm3) has been reported in 7.5% of patients with normal LFTs at baseline and 27.3% of patients with elevated LFTs.

Anemia (less than 11 g/dL) has been reported in 89.5% of patients with normal LFTs at baseline and 92.7% of patients with elevated LFTs. Anemia (less than 8 g/dL) has been reported in 8.4% of patients with normal LFTs and 30.9% of patients with elevated LFTs.

Febrile neutropenia has been reported in 11.8% of patients with normal LFTs at baseline and 26.4% of patients with elevated LFTs.

Hypersensitivity

In one institution's experience with 623 courses of docetaxel therapy (n = 168), hypersensitivity reactions decreased from 50% to 5% once patients began receiving systemic prophylaxis including corticosteroids and antihistamines.

Hypersensitivity side effects may occur within a few minutes following initiation of a docetaxel infusion. Severe hypersensitivity reactions characterized by hypotension and/or bronchospasm, or generalized rash/erythema occurred in 0.9% of patients who received the recommended dexamethasone premedication. Hypersensitivity reactions requiring discontinuation of therapy have been reported in 5 of 1260 patients who did not receive premedication. Minor events, including flushing, rash with or without pruritus, chest tightness, back pain, dyspnea, drug fever or chills have also been reported and resolved after discontinuation of the infusion and initiation of appropriate therapy. Bullous eruption including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely. Rare cases of anaphylactic shock have been reported during postmarketing experience. Very rarely, these cases resulted in a fatal outcome in patients who received premedication.

General

General side effects including diffuse pain, chest pain, and radiation recall phenomenon have been reported.

Severe adverse events have been reported in 49% of patients treated with docetaxel 60 mg/m2 compared to 55.3% and 65.9% treated with 75 mg/m2 and 100 mg/m2 respectively. Discontinuation due to adverse events was reported in 5.3% of patients treated with 60 mg/m2 versus 6.9% and 16.5% for patients treated at 75 mg/m2 and 100 mg/m2 respectively. Deaths within 30 days of last treatment occurred at a rate of 4.0% in patients treated with 60 mg/m2 compared to 5.3% and 1.6% for patients treated at 75 mg/m2 and 100 mg/m2 respectively.

Cardiovascular

Cardiovascular side effects including hypotension have been reported in 3.6% of patients (3.4% required treatment). Heart failure, sinus tachycardia, atrial fibrillation, atrial flutter, dysrhythmia, unstable angina, pulmonary edema, deep vein thrombosis, ECG abnormalities, thrombophlebitis, pulmonary embolism, syncope, myocardial infarction, and hypertension have also been reported.

Renal

Renal side effects including severe fluid retention (generally renal in origin and generally after four to five courses of therapy) have been reported in patients using a five day dexamethasone premedication regimen. The fluid retention 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). Renal insufficiency has been reported during postmarketing experience with the majority of these cases associated with concomitant nephrotoxic drugs.

Moderate fluid retention (17.4%), severe fluid retention (6%) and discontinuation (1.7%) have been reported among 229 patients with normal liver function using a five day dexamethasone premedication regimen. Fluid retention was completely, but sometimes slowly reversible resolving in a median of 29 weeks following discontinuation. The median cumulative dose to the onset of moderate or severe fluid retention was 705 mg/m2 (in patients receiving premedication). In a summary of 37 clinical trials (n = 1,495), fluid retention was reported in 48.5% of patients with normal LFTs at baseline and 66.7% of patients with elevated LFTs. In the same trials, severe fluid retention was reported in 5.2% of patients with normal LFTs at baseline and 33.3% of patients with elevated LFTs. Patients developing peripheral edema may be treated with standard measures including salt restriction, diuretics (e.g. spironolactone), etc.

Nervous system

Spontaneous reversal of symptoms occurred in a median of 9 weeks from onset. Approximately 3.8% of the 134 patients required discontinuation of therapy due to neurotoxicity. In a summary of 37 clinical trials (n = 1,495), neurosensory symptoms were reported in 53.7% of patients with normal LFTs at baseline and 41.8% of patients with elevated LFTs. In the same trials, severe neurosensory symptoms were reported in 3.9% of patients with normal LFTs at baseline and none of the patients with elevated LFTs. In a study (n = 46) of 209 cycles, peripheral neurotoxicity was reported in 30% of patients. In another study (n = 186), 11% of patients developed mild to moderate sensory neuropathy at cumulative doses ranging from 50 to 750 mg/m2 and doses of 10 to 115 mg/m2.

Nervous system side effects including paresthesia, dysesthesia, and pain (7%) have been reported in one study (n = 134). Confusion and rare cases of seizures or transient loss of consciousness have been reported, sometimes appearing during the infusion of the drug.

Hepatic

Hepatic side effects including various increases in blood levels have been reported. In patients with normal LFTs at baseline, bilirubin values greater than the upper limit of normal (ULN) occurred in 8.9% of patients. Increases in SGOT or SGPT greater than 1.5 times the ULN, or alkaline phosphatase greater than 2.5 times the ULN were observed in 18.1% and 7.6% of patients, respectively. Increases in SGOT and/or SGPT greater than 1.5 times the ULN concomitant with alkaline phosphatase greater than 2.5 times the ULN occurred in 4.5% of patients with normal LFTs at baseline. Rare cases of hepatitis have been reported during postmarketing experience.

Gastrointestinal

In a summary of 37 clinical trials (n = 1,495), nausea has been reported in 40.4% of patients with normal LFTs at baseline and 40% of patients with elevated LFTs. Diarrhea has been reported in 40.4% of patients with normal LFTs at baseline and 32.7% of patients with elevated LFTs. Vomiting has been reported in 24% of patients with normal LFTs at baseline and 25.5% of patients with elevated LFTs. Severe GI reactions were reported in 8.2% of patients.

Stomatitis has been reported in 42.3% of patients with normal LFTs at baseline and 47.3% of patients with elevated LFTs. Severe stomatitis has been reported in 5.3% of patients with normal LFTs at baseline and 14.5% of patients with elevated LFTs. Stomatitis appears to be dose dependent.

Gastrointestinal (GI) side effects including nausea, vomiting, diarrhea, stomatitis abdominal pain, anorexia, constipation, duodenal ulcer, esophagitis, GI hemorrhage, GI perforation, ischemic colitis, colitis, intestinal obstruction, ileus, neutropenic enterocolitis, ischemic colitis, and dehydration as a consequence to GI events have been reported.

Dermatologic

Dermatologic side effects including reversible cutaneous reactions characterized by a rash including localized eruptions, mainly on the feet and/or hands, but also on the arms, face or thorax (and usually associated with pruritus) have been reported. Severe hand and foot syndrome has been reported. Severe nail disorders (2.6%), alopecia, and localized erythema of the extremities with edema followed by desquamation have also been reported. Very rare cases of cutaneous lupus erythematosus have been reported. Scleroderma-like changes usually preceded by peripheral lymphedema have been reported. One case of supravenous discoloration of the skin due to docetaxel treatment has been reported.

Eruptions generally occurred within one week after dosage administration and were not disabling. Recovery generally occurred before the next infusion.

In a summary of 37 clinical trials (n = 1,495), cutaneous adverse events have been reported in 58.5% of patients with normal LFTs at baseline and 61.8% of patients with elevated LFTs. In the same trials, severe cutaneous adverse events have been reported in 5.6% of patients with normal LFTs at baseline and 10.9% of patients with elevated LFTs. The discontinuation rate due to skin toxicity was 1.7%. Alopecia has been reported in 80% of patients with normal LFTs at baseline and 61.8% of patients with elevated LFTs. In one study (n = 46) of 209 cycles, alopecia was reported in 91% of patients. In one institution's experience with 623 courses of docetaxel therapy (n = 168), dermatologic toxicity decreased from 53% to 14% once patients began receiving systemic prophylaxis including corticosteroids and antihistamines.

Severe nail disorder were characterized by hypo- or hyperpigmentation and occasionally by onycholysis (0.8%) and pain.

Local

Local side effects consisting of infusion site reactions have been reported. These reactions were generally mild and consisted of hyperpigmentation, inflammation, redness or dryness of the skin, phlebitis, extravasation or swelling of the vein. Rare cases of transient visual disturbances (flashes, flashing lights, scotomata) typically occurring during drug infusion and in association with hypersensitivity reactions have been reported during postmarketing experience. These were reversible upon discontinuation of the infusion.

Other

In a summary of 37 clinical trials (n = 1,495), asthenia has been reported in 61.5% of patients with normal LFTs at baseline and 54.5% of patients with elevated LFTs. In the same trials, severe asthenia has been reported in 11.1% of patients with normal LFTs at baseline and 23.6% of patients with elevated LFTs. In a study (n = 46) of 209 cycles, malaise was reported in 52% of patients.

Other side effects have included asthenia (11.1% to 61.5%) and malaise (52%). Fatigue and weakness have been reported to have lasted a few days to several weeks and were occasionally associated with deterioration of performance status in patients with progressive disease. Rare cases of ototoxicity, hearing disorders and/or hearing loss have been reported, including cases associated with other ototoxic drugs. A case of docetaxel-induced recall dermatitis on previous laser treatment sites has also been reported.

Ocular

Ocular side effects including conjunctivitis and lacrimation have been reported. Canalicular and nasolacrimal duct obstruction has been a common side effect of weekly docetaxel therapy and has even been reported to occur when docetaxel is used in the neoadjuvant setting according to one study. Excessive tearing which may be attributable to lacrimal duct obstruction has also been reported.

Respiratory

Respiratory side effects including dyspnea, acute pulmonary edema, acute respiratory distress syndrome, and interstitial pneumonia have been reported. Pulmonary fibrosis has been rarely reported.

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