Taxotere Side Effects

Generic Name: docetaxel

Note: This page contains side effects data for the generic drug docetaxel. It is possible that some of the dosage forms included below may not apply to the brand name Taxotere.

It is possible that some side effects of Taxotere may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to docetaxel: intravenous powder for solution, intravenous solution

As well as its needed effects, docetaxel (the active ingredient contained in Taxotere) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking docetaxel, check with your doctor or nurse immediately:

More common
  • Burning, numbness, tingling, or pain in the arms, hands, legs, or feet
  • swelling of the stomach, face, fingers, hands, feet, or lower legs
  • unusual tiredness or weakness
  • weight gain
Less common
  • Black, tarry stools
  • blood in the urine or stools
  • cough or hoarseness (accompanied by fever or chills)
  • difficult or labored breathing
  • difficult or painful urination (accompanied by fever or chills)
  • difficulty with swallowing
  • dizziness
  • fast heartbeat
  • fever or chills
  • hives
  • itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • lower back or side pain (accompanied by fever or chills)
  • noisy, rattling breathing
  • pinpoint red spots on the skin
  • red, scaly, swollen, or peeling areas of the skin (severe)
  • skin rash
  • tightness in the chest
  • troubled breathing while at rest
  • unusual bleeding or bruising
Rare
  • Chest pain or discomfort
  • decreased blood pressure
  • fast or irregular heartbeat
  • increased blood pressure

Some docetaxel side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Congestion
  • diarrhea
  • dryness or soreness of the throat
  • nausea
  • skin rash or redness (mild)
  • sores or ulcers on the lips or tongue or inside the mouth
  • weakness in the arms, hands, legs, or feet
Less common
  • Bloody nose
  • body aches or pain
  • change in the color of the fingernails or toenails
  • dry, red, hot, or irritated skin at the injection site
  • headache
  • hoarseness
  • loosening or loss of the fingernails or toenails, sometimes painful
  • pain in the joints or muscles
  • pain, swelling, or lump under the skin at the injection site
  • runny nose
  • tender, swollen glands in the neck
  • voice changes
  • vomiting
incidence not known
  • Burning, dry, or itching eyes
  • burning upper abdominal or stomach pain
  • confusion
  • difficulty having a bowel movement (stool)
  • discharge from the eyes
  • excessive tearing
  • mood or mental changes
  • pain and redness of the skin at the place of earlier radiation treatment
  • rapid breathing
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sunken eyes
  • tearing of the eyes
  • wrinkled skin

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 (up to 99%), leukopenia (up to 99%), thrombocytopenia (up to 39%), anemia (up to 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 (up to 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 (up to 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 (up to 98%), cutaneous reactions (up to 54%), nail changes (up to 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 (up to 58%), dizziness (up to 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

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]

Very common (10% or more): Transaminase elevations, (18.9%)
Common (1% to 10%): Bilirubin elevations, alkaline phosphatase elevations, transaminase elevations in combination with alkaline phosphatase elevations
Postmarketing reports: Hepatitis[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 (up to 52%), nausea (up to 42%), vomiting (up to 23%), diarrhea (up to 43%), constipation (up to 25%), esophagitis/dysphagia/odynophagia (up to 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 (up to 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 (up to 15%), weight loss (up to 21%)
Common (1% to 10%): Anorexia
Postmarketing reports: Hyponatremia[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 33%)
Common (1% to 10%): Severe myalgia, arthralgia, bone pain, back pain[Ref]

Immunologic

Very common (10% or more): Infections (up to 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 (up to 62%)
Common (1% to 10%): Menstrual irregularities[Ref]

References

1. "Product Information. Taxotere (docetaxel)." Rhone-Poulenc Rorer, Collegeville, PA.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web2)