Taxotere: Side Effects and Safety Information

Docetaxel, commonly known by its brand name Taxotere, is a chemotherapy drug that treats several cancer types, including breast and prostate cancer.

It belongs to the taxane class of chemotherapy drugs and works by stopping cancer cells from dividing. Originally approved in 1996 to treat breast cancer, Taxotere has since received approval to treat several other cancers.

Sanofi manufactures and distributes Taxotere, which remains a commonly used chemotherapy drug for breast and other cancers.

According to the drug’s label, Taxotere’s most common side effects include infections, blood disorders and nausea. Its potentially severe side effects may include eye disorders, abnormal physical weakness and neurologic reactions.

Tell your doctor about any side effects you experience to make sure they aren’t signs of a more serious problem.

Serious Taxotere Side Effects

Taxotere can also cause rare but serious side effects, including death. It’s important to discuss the following symptoms and conditions with your doctor.

The risk of death with Taxotere treatment is higher in people with liver problems, those receiving high doses of Taxotere and those with non-small cell lung cancer who have used chemotherapy drugs containing platinum.

While temporary hair loss is a common side effect of chemotherapy treatment, studies have found that Taxotere may cause permanent hair loss, or persistent chemotherapy-induced alopecia (pCIA). Patients have pCIA when their hair does not completely grow back six months after stopping treatment.

This can have a serious impact on a patient’s life, and it may even lead to inconsistencies with treatment. Patients have referred to the permanent hair loss as “devastating,” “depressing” and “very upsetting.”

One former Taxotere breast cancer patient, Amy Dodson, shared her story with Drugwatch. Dodson said no one ever warned her about permanent alopecia. Dodson said permanent hair loss affected her marriage, self-esteem and self-image, along with the lives of her kids.

Even after she was in remission and had not had treatment for five years, strangers would think she was still an active cancer patient because of her hair loss.

Studies of Taxotere and Permanent Hair Loss

Over the years, a few studies have linked Taxotere to permanent hair loss.

People who filed Taxotere lawsuits against Sanofi claimed the company knew that the drug could cause permanent hair loss but failed to warn patients. Sanofi eventually changed the label to mention permanent hair loss in 2015.

As of May 2025, more than 6,400 cases are still pending in multidistrict litigation (MDL) in the U.S. District Court for the Eastern District of Louisiana. Multidistrict litigation groups multiple similar cases together into one legal proceeding to streamline the legal process.

FDA Warnings, Label Changes & Manufacturer History

Taxotere first received FDA approval in 1996, and Sanofi didn’t change Taxotere’s label to warn about permanent hair loss until 2015. Before the label change, Taxotere’s original label said “hair generally grows back.”

Between 2004 and 2008, the FDA approved several label changes requested by Sanofi, but none of them mentioned permanent hair loss. The FDA did not release any safety communications about Taxotere causing permanent hair loss.

However, lawsuits claim Sanofi knew by 2005 that Taxotere could cause permanent hair loss because a Sanofi-sponsored study found that 9.2% of patients had hair loss lasting for roughly 10 years.

In a legal analysis, U.S. District Judge Jane Triche Milazzo noted that, while data regarding permanent hair loss may have been available in 2004, Sanofi didn’t analyze or highlight it for the FDA. Even after 2004, the drug maker didn’t alert the FDA about growing reports of permanent alopecia.

When Sanofi added language about hair loss to the Taxotere label in 2015, according to lawsuits, it included the following language about permanent hair loss:

• “Cases of permanent alopecia have been reported.”
• “Side effects such as [. . .] hair loss (cases of permanent hair loss have been reported) are associated with docetaxel administration.”
• The “most common side effects” include “hair loss, in most cases normal hair growth should return. In some cases (frequency not known) permanent hair loss has been observed.”

In 2020, a U.S. District Court judge dismissed around 200 failure-to-warn claims after ruling the 2015 label adequately warned about permanent hair loss.

Taxotere has never been recalled for permanent hair loss. However, generic docetaxel manufacturer Sagent Pharmaceuticals recalled two lots of docetaxel in May 2024 because of customer complaints of particulate matter in the product.

FDA-approved labeling changes clarify information from new safety data after a drug’s initial approval. They aren’t the same as a drug recall, which is a removal or correction of a product that the FDA believes violates the law.

Some side effects of Taxotere are serious, and you should speak to your medical provider right away about any symptoms you experience.

Your doctor may have some options for dealing with Taxotere hair loss. Minoxidil (commonly known by its brand name Rogaine), photobiomodulation (PBMT) and platelet-rich plasma (PRP) are some treatments that can help regrow hair. Wigs are also an option, and cancer support groups may help you deal with the emotional side effects of permanent hair loss.

You may also have the option to file a Taxotere lawsuit. If you are interested, speak to an attorney immediately because there may be a time limit (known as the statute of limitations) to file a case.