DOCETAXEL ANHYDROUS

85/100 · Critical

Manufactured by Hospira, Inc.

Docetaxel Anhydrous Adverse Events: High Seriousness and Diverse Reactions

152,096 FDA adverse event reports analyzed

Last updated: 2026-05-12

About DOCETAXEL ANHYDROUS

DOCETAXEL ANHYDROUS is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Hospira, Inc.. Based on analysis of 152,096 FDA adverse event reports, DOCETAXEL ANHYDROUS has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for DOCETAXEL ANHYDROUS include ALOPECIA, MADAROSIS, HAIR TEXTURE ABNORMAL, HAIR COLOUR CHANGES, HAIR DISORDER. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOCETAXEL ANHYDROUS.

AI Safety Analysis

Docetaxel Anhydrous has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 152,096 adverse event reports for this medication, which is primarily manufactured by Hospira, Inc..

The most commonly reported adverse events include Alopecia, Madarosis, Hair Texture Abnormal. Of classified reports, 77.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Docetaxel anhydrous is associated with a high incidence of serious adverse events, particularly neutropenia and infections.

The drug is linked to a wide range of reactions, including hematological, gastrointestinal, and respiratory issues. Significant psychological and neurological effects, such as anxiety and neuropathy, are also reported.

Patients taking Docetaxel Anhydrous should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Docetaxel anhydrous can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be careful This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.

Safety Score: 85/100

Docetaxel Anhydrous received a safety concern score of 85/100 (high concern). This is based on a 77.9% serious event ratio across 65,204 classified reports. The score accounts for 152,096 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.

Top Adverse Reactions

ALOPECIA16,937 reports
MADAROSIS6,713 reports
HAIR TEXTURE ABNORMAL5,993 reports
HAIR COLOUR CHANGES5,874 reports
HAIR DISORDER5,625 reports
DIARRHOEA5,121 reports
NAUSEA3,703 reports
EMOTIONAL DISTRESS3,614 reports
ANXIETY3,451 reports
NEUTROPENIA3,269 reports
FATIGUE3,136 reports
FEBRILE NEUTROPENIA2,974 reports
MALIGNANT NEOPLASM PROGRESSION2,674 reports
VOMITING2,674 reports
DISEASE PROGRESSION2,540 reports
OFF LABEL USE2,455 reports
PYREXIA2,425 reports
PAIN2,316 reports
DYSPNOEA2,304 reports
ANAEMIA2,164 reports
MYELOSUPPRESSION2,032 reports
ASTHENIA1,938 reports
DEATH1,794 reports
DECREASED APPETITE1,735 reports
DRUG INEFFECTIVE1,649 reports
NEUROPATHY PERIPHERAL1,600 reports
INJURY1,413 reports
DISCOMFORT1,351 reports
PNEUMONIA1,340 reports
THROMBOCYTOPENIA1,337 reports
MUCOSAL INFLAMMATION1,242 reports
ABDOMINAL PAIN1,182 reports
WHITE BLOOD CELL COUNT DECREASED1,166 reports
RASH1,131 reports
LEUKOPENIA1,116 reports
SEPSIS1,115 reports
ANHEDONIA1,051 reports
DEHYDRATION997 reports
ARTHRALGIA976 reports
HEADACHE972 reports
NEUTROPHIL COUNT DECREASED964 reports
COUGH961 reports
STOMATITIS940 reports
MALAISE936 reports
DIZZINESS935 reports
DEPRESSION916 reports
DEFORMITY915 reports
PALMAR PLANTAR ERYTHRODYSAESTHESIA SYNDROME889 reports
INTERSTITIAL LUNG DISEASE884 reports
METASTASES TO BONE876 reports
BACK PAIN848 reports
PLEURAL EFFUSION845 reports
GENERAL PHYSICAL HEALTH DETERIORATION830 reports
CONSTIPATION829 reports
MYALGIA794 reports
PSYCHOLOGICAL TRAUMA787 reports
ERYTHEMA785 reports
PRURITUS759 reports
NEOPLASM PROGRESSION703 reports
METASTASES TO LIVER696 reports
HYPOTENSION681 reports
PRODUCT USE IN UNAPPROVED INDICATION677 reports
WEIGHT DECREASED669 reports
CHILLS629 reports
OEDEMA PERIPHERAL629 reports
HYPOKALAEMIA627 reports
TOXICITY TO VARIOUS AGENTS620 reports
ACUTE KIDNEY INJURY605 reports
LACRIMATION INCREASED605 reports
METASTASES TO LUNG599 reports
PLATELET COUNT DECREASED596 reports
TACHYCARDIA595 reports
EJECTION FRACTION DECREASED590 reports
PNEUMONITIS586 reports
INFECTION572 reports
HYPERSENSITIVITY558 reports
PAIN IN EXTREMITY554 reports
PULMONARY EMBOLISM553 reports
CONDITION AGGRAVATED544 reports
METASTASES TO CENTRAL NERVOUS SYSTEM544 reports
BONE MARROW FAILURE540 reports
RESPIRATORY FAILURE531 reports
INSOMNIA527 reports
URINARY TRACT INFECTION527 reports
HYPERTENSION515 reports
FLUSHING514 reports
ASCITES506 reports
SYNCOPE500 reports
FALL498 reports
METASTASES TO LYMPH NODES495 reports
BONE PAIN493 reports
CHEST PAIN491 reports
IMPAIRED QUALITY OF LIFE491 reports
ALANINE AMINOTRANSFERASE INCREASED478 reports
ABDOMINAL PAIN UPPER476 reports
OSTEONECROSIS OF JAW466 reports
NEUTROPENIC SEPSIS462 reports
EPISTAXIS456 reports
PARAESTHESIA454 reports
CHEST DISCOMFORT452 reports

Key Safety Signals

  • Neutropenia and febrile neutropenia are the most common serious adverse events.
  • Alopecia and hair disorders are frequent dermatological reactions.
  • Neurological effects, including neuropathy and psychological distress, are notable safety signals.

Patient Demographics

Adverse event reports by sex: Female: 35,926, Male: 15,963, Unknown: 333. The most frequently reported age groups are age 60 (1,344 reports), age 62 (1,336 reports), age 61 (1,332 reports). These demographics reflect reporting patterns and may not represent the full patient population.

Report Outcomes

Out of 65,204 classified reports for DOCETAXEL ANHYDROUS:

  • Serious: 50,770 reports (77.9%) — includes hospitalization, disability, life-threatening events, or death
  • Non-Serious: 14,434 reports (22.1%)
Serious 77.9%Non-Serious 22.1%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female35,926 (68.8%)
Male15,963 (30.6%)
Unknown333 (0.6%)

Reports by Age

Age 601,344 reports
Age 621,336 reports
Age 611,332 reports
Age 651,326 reports
Age 591,287 reports
Age 631,233 reports
Age 551,230 reports
Age 541,221 reports
Age 581,212 reports
Age 661,206 reports
Age 681,205 reports
Age 691,181 reports
Age 571,179 reports
Age 521,176 reports
Age 561,170 reports
Age 701,145 reports
Age 641,123 reports
Age 671,123 reports
Age 511,090 reports
Age 501,084 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Drug Interactions & Warnings

Docetaxel anhydrous can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be careful

What You Should Know

If you are taking Docetaxel Anhydrous, here are important things to know. The most commonly reported side effects include alopecia, madarosis, hair texture abnormal, hair colour changes, hair disorder. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should be closely monitored for signs of infection, particularly neutropenia and febrile neutropenia, and treated promptly if detected. Regular blood tests are essential to monitor hematological parameters and adjust treatment as necessary. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.

Regulatory Context

The FDA continues to monitor the safety of docetaxel anhydrous, and healthcare providers are advised to report any adverse events to the FDA's MedWatch program.

Frequently Asked Questions

How many adverse event reports has the FDA received for Docetaxel Anhydrous?

The FDA has received approximately 152,096 adverse event reports associated with Docetaxel Anhydrous. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.

What are the most commonly reported side effects of Docetaxel Anhydrous?

The most frequently reported adverse events for Docetaxel Anhydrous include Alopecia, Madarosis, Hair Texture Abnormal, Hair Colour Changes, Hair Disorder. By volume, the top reported reactions are: Alopecia (16,937 reports), Madarosis (6,713 reports), Hair Texture Abnormal (5,993 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Docetaxel Anhydrous.

What percentage of Docetaxel Anhydrous adverse event reports are serious?

Out of 65,204 classified reports, 50,770 (77.9%) were classified as serious and 14,434 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.

Who reports adverse events for Docetaxel Anhydrous (by sex)?

Adverse event reports for Docetaxel Anhydrous break down by patient sex as follows: Female: 35,926, Male: 15,963, Unknown: 333. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.

What age groups report the most side effects for Docetaxel Anhydrous?

The most frequently reported age groups for Docetaxel Anhydrous adverse events are: age 60: 1,344 reports, age 62: 1,336 reports, age 61: 1,332 reports, age 65: 1,326 reports, age 59: 1,287 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.

Who manufactures Docetaxel Anhydrous?

The primary manufacturer associated with Docetaxel Anhydrous adverse event reports is Hospira, Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.

What other side effects have been reported for Docetaxel Anhydrous?

Beyond the most common reactions, other reported adverse events for Docetaxel Anhydrous include: Diarrhoea, Nausea, Emotional Distress, Anxiety, Neutropenia. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.

How do I report a side effect from Docetaxel Anhydrous?

You can report adverse events from Docetaxel Anhydrous to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.

What is Docetaxel Anhydrous's safety score and what does it mean?

Docetaxel Anhydrous has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Docetaxel anhydrous is associated with a high incidence of serious adverse events, particularly neutropenia and infections.

What are the key safety signals for Docetaxel Anhydrous?

Key safety signals identified in Docetaxel Anhydrous's adverse event data include: Neutropenia and febrile neutropenia are the most common serious adverse events.. Alopecia and hair disorders are frequent dermatological reactions.. Neurological effects, including neuropathy and psychological distress, are notable safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.

Does Docetaxel Anhydrous interact with other drugs?

Docetaxel anhydrous can cause severe hematological and gastrointestinal side effects, and patients should be monitored closely for signs of infection and myelosuppression. Drug interactions, particularly with other cytotoxic agents, should be careful Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Docetaxel Anhydrous.

What should patients know before taking Docetaxel Anhydrous?

Patients should be closely monitored for signs of infection, particularly neutropenia and febrile neutropenia, and treated promptly if detected. Regular blood tests are essential to monitor hematological parameters and adjust treatment as necessary.

Are Docetaxel Anhydrous side effects well-documented?

Docetaxel Anhydrous has 152,096 adverse event reports on file with the FDA. The drug is linked to a wide range of reactions, including hematological, gastrointestinal, and respiratory issues. The volume of reports for Docetaxel Anhydrous reflects both the drug's usage level and the vigilance of the reporting community.

What is the FDA's position on Docetaxel Anhydrous?

The FDA continues to monitor the safety of docetaxel anhydrous, and healthcare providers are advised to report any adverse events to the FDA's MedWatch program. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.

Related Drugs

Drugs related to DOCETAXEL ANHYDROUS based on therapeutic use, drug class, or shared indications:

CisplatinPaclitaxelEtoposide
Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.