Taxotere Safety Information
Black Box Warning
Toxic death, low blood cell counts, liver toxicity, fluid retention, hypersensitivity reactions
Most Reported Side Effects
Blood disorders (low blood cell count, anemia), hair loss, fluid retention, nausea, vomiting, fatigue, excessive tearing from the eyes (epiphora)
Ways to Prevent or Lower Side Effect Risk
Take antihistamines and corticosteroids before therapy, lower medication dose, discontinue medication
Pregnancy Risk
Causes harm to unborn babies; breastfeeding not recommended

Latest Side Effects Information for Taxotere

As of March 31, 2024, alopecia, emotional distress, psychological trauma and anxiety were the most frequently reported Taxotere side effects, according to the U.S. Food and Drug Administration (FDA).

FDA ADVERSE EVENT REPORTS FOR TAXOTERE SIDE EFFECTS
Total cases reported35,038
Serious cases (including deaths)26,786
Deaths3,278
Source: FAERS Database

Disclaimer: Reports sent to the FDA don’t necessarily mean the drug caused an adverse event. Consult a health care professional before stopping or changing medication.

Common Taxotere Side Effects

The two most common side effects of taking the chemotherapy drug Taxotere are low white blood cell count (neutropenia) and anemia. According to the FDA, clinical trials found that of those who received 100 mg/m2 of Taxotere, 98% of breast cancer patients with normal liver function and 100% of those with elevated liver function, experienced neutropenia.

Even at a lower dosage of 60 mg/m2, taking the drug resulted in neutropenia in 95% of patients with normal liver function or NLF. Severe neutropenia was a side effect with a 100 mg/m2 dosage in 84% of patients with NLF. Anemia rates are nearly as high, occurring in 95% of patients with NLF and 94% of patients with elevated liver function, or ELF. However, the rate drops significantly to 65% in those with NLF who receive the lower dose.

Clinical trials demonstrate that Taxotere treatment for any tumor type commonly results in the following side effects and prevalence rates for those with NLF.

Rates of Side Effects
  • Neutropenia (96%)
  • Leukopenia (96%)
  • Anemia (90%)
  • Alopecia (76%)
  • Asthenia (62%)
  • Skin reactions (48%)
  • Fluid retention (47%)
  • Stomatitis (42%)
  • Nausea (39%)
  • Diarrhea (39%)
  • Fever in absence of infection (31%)
  • Nail disorders (31%)
  • Infections (22%)
  • Vomiting (22%)

Taxotere combined with doxorubicin and cyclophosphamide leads to side effects not seen when used alone, including amenorrhea in 62% of patients, constipation in 34%, neuropathy in 26% and anorexia in 22%.

As with other chemotherapy drugs, low white blood cell count is the most common adverse effect for patients taking Taxotere. Almost all patients experience neutropenia, and 85% of those on a 100 mg/m2 dose see a severe decline in their white blood cell count. Severe neutropenia increases the risk of infections. This increased risk leads doctors to reduce dosing or pause treatment until counts return to an acceptable number.

White blood cell counts are usually at their lowest point between 10-14 days after treatment. Those with milder neutropenia often see their counts increase to safer levels before they receive their subsequent treatment. People with cancer are almost three times as likely to die from infection compared to those who don’t have cancer, and patients receiving chemotherapy have the highest risk.

Long-Term Side Effects of Taxotere

Long-term side effects of docetaxel, the active ingredient in Taxotere, include alopecia, neuropathy, heart damage and cancer. Some long-term side effects may take months to resolve or, in some cases, continue indefinitely.

Taxotere Long-Term Side Effects
Acute Myeloid Leukemia
AML is a rare but potentially fatal side effect. Research suggests the risk is higher when patients receive Taxotere combined with other agents.
Alopecia
This condition results in long-term or permanent hair loss.
Cardiotoxicity
Heart damage is a rare Taxotere side effect. However, docetaxel combined with other drugs increases the risk of heart damage.
Myelodysplastic Syndrome
This disease is related to AML, a type of bone marrow cancer, and is very rare.
Neuropathy
Motor and vision issues are the two most prevalent neuropathy side effects for patients taking Taxotere.

Peripheral Neuropathy

Peripheral neuropathy is a condition that involves damage to the peripheral nerves and has many potential symptoms. Women with invasive breast cancer receiving docetaxel were most likely to exhibit the neuropathy symptoms of muscle weakness in their legs and blurred vision, according to a 2022 report published in the Journal of the American Medical Association.

A studypublished in the European Journal of Cancer involving over 1,000 women with early-stage breast cancer found that 15% of those who survived breast cancer experienced significant symptoms from peripheral neuropathy. These symptoms lasted for one to three years after completing treatment and discontinuing their use of docetaxel.

Alopecia

While hair loss is common in chemotherapy patients, it is usually temporary. Alopecia, however, is a permanent hair loss condition. Research from the U.K. published in the European Journal of Cancer suggests that almost a quarter of women who use Taxotere could experience long-term hair loss. The researchers found that 23.3% of the women in the study experienced alopecia. They also found that postmenopausal women may be at higher risk.

Though the Taxotere drug sheet identifies alopecia as a potential side effect, plaintiffs have filed over 10,000 lawsuits against Taxotere’s maker, Sanofi. Plaintiffs allege that the manufacturer was aware of the risk of alopecia but failed to provide sufficient warning to consumers.

Case Study: Breast Cancer Survivor and Taxotere

Over 1,600 breast cancer survivors who used the chemotherapy drug Taxotere now have alopecia. This side effect serves as a constant reminder of their illness and affects their daily lives.

Ami Dodson’s Experience
Ami Dodson, a breast cancer survivor featured in Drugwatch’s “Beyond the Side Effects,” has chemo-induced alopecia, which she claims Taxotere caused. Diagnosed with aggressive breast cancer at 35, she underwent treatment with Taxotere and later discovered her hair would never grow back.

“I finally realized this is not slow growth,” Dodson said. “This is your hair follicles are dead and they’re not coming back. Then my oncologist gave me a diagnosis of permanent chemo-induced alopecia.”

Taxotere vs. Taxol
Taxotere is commonly used in the U.S. because it requires fewer treatments. However, compared to a similar drug, Taxol, it has a higher risk of permanent hair loss. Many women, including Dodson, were unaware of this risk and would have chosen differently if they had known.

Living with Alopecia
Dodson’s permanent hair loss has significantly altered her life, affecting her self-esteem, family interactions and daily routines. She now wears a bonded topper wig, which requires extensive maintenance.

Lawsuit Information
Lawsuits are being filed by women who were prescribed Taxotere to treat their breast cancer and later suffered permanent hair loss and eye damage.
Learn More

Additional Taxotere Side Effects During and After Treatment

Febrile neutropenia and thrombocytopenia are less common in patients with NLF, but patients with ELF frequently experience these conditions. Additionally, patients receiving chemotherapy treatment that combines Taxotere with other agents, such as doxorubicin or cyclophosphamide, are at the highest risk of other possible adverse effects.

Other Possible Side Effects
Epiphora
Watery eyes are the hallmarks of this condition.
Febrile Neutropenia
People with this condition have a low white blood cell count and a fever. This could indicate infection and is potentially life-threatening.
Gastrointestinal Complications and Pneumonitis
Gastrointestinal distress, including bleeding and lung disease, occur in some patients. Both conditions are rare.
Myalgia
Generalized musculoskeletal pain is myalgia’s primary symptom. Pain usually occurs within hours or days of treatment.
Severe Fluid Retention
Minor fluid retention that results in swelling of the extremities is common. However, severe symptoms, though rare, can be life-threatening,
Symptoms of Alcohol Intoxication
Docetaxel contains ethanol. It may cause signs of alcohol intoxication in some patients.
Thrombocytopenia
This condition occurs in those with lower platelet levels in their blood. It is more prevalent in those with ELF.

These side effects, though rare, are often distressing and painful. Patients may request treatment discontinuation, or physicians may pause treatment to address the side effects. However, these conditions are usually short-term and treatable.

Epiphora: Taxotere Eye Problem Risk

A 2021 study published in the Multidisciplinary Digital Publishing Institute found a significant link between docetaxel use and epiphora, which is a condition involving chronically watery eyes. However, the study did not find a statistically significant distinction concerning dosage frequency. The prevalence of epiphora between patients receiving treatment once a week and those receiving it every three weeks was 41.22% and 34.15%, respectively.

Canalicular stenosis, which is a condition that causes partial or total tear duct blockage, may be the underlying cause of epiphora. Because the condition interferes with daily activities such as reading, driving or watching TV, many patients reported a reduced quality of life. Nearly 200 patients who alleged that Taxotere caused them to develop canalicular stenosis have filed lawsuits against Sanofi.

Fluid Retention

Severe fluid retention, particularly in the extremities, can be an uncomfortable and potentially life-threatening condition. It primarily affects patients receiving treatment for breast cancer.

According to the FDA, moderate fluid retention occurred in 27.2% of patients pre-treated with corticosteroids. Another 6.5% experienced severe fluid retention. However, according to a 2023 study published in the Journal of Scientific Reports, treating patients with high doses of dexamethasone may significantly decrease symptoms or prevent fluid retention.

Infusion Reactions

Initial research into docetaxel indicated that patients frequently experienced infusion reactions, leading to steroid and antihistamine pretreatment. However, despite the precaution, research suggests that approximately 10% of patients still have an adverse reaction within minutes of injection, with 1% having a severe infusion reaction.

The most common symptoms include flushing, throat tightness, dyspnea and hypotension. Rarer symptoms include back and chest pain. Some patients experience rashes that occur within hours to weeks after receiving an infusion. Infusion reactions most often arise after the first or second treatment.

How to Cope With Taxotere Side Effects

Though Taxotere is an effective cancer treatment, learning to cope with the side effects is necessary for many patients to continue receiving the medication.

Steps to Cope With Taxotere Side Effects
  1. Discuss possible side effects with the oncologist before taking Taxotere.
  2. After treatment begins, document side effects and discuss them with the oncologist.
  3. Follow the oncologist’s recommendations for managing side effects.
  4. Discuss potential new approaches that may eliminate or reduce drug interactions or other complications.
  5. Speak with fellow patients in support groups and other forums to learn about alternatives that may cause fewer side effects.

Side effects vary in time of onset and severity. Those receiving treatment should remain vigilant for unusual symptoms between appointments and after the treatment finishes.

When experiencing mild symptoms, getting sufficient rest and nutrition and engaging in light exercise are essential to helping the body cope. However, patients should consider seeking immediate medical attention if they have signs of a severe reaction, such as breathing difficulties, fever, swelling at the injection site or in the extremities and mouth or throat pain.

Editor Lindsay Donaldson contributed to this article.

Please seek the advice of a medical professional before making health care decisions.