Drug Safety Information for TAXOTERE (Docetaxel)

Safety-related Labeling Changes for TAXOTERE (DOCETAXEL) Rx Drug: FDA Link

Safety-related Labeling Changes for DOCETAXEL (DOCETAXEL) Rx Drug: FDA Link

Safety-related Labeling Changes for DOCEFREZ (DOCETAXEL) Discontinued Drug: FDA Link

Safety-related Labeling Changes for DOCEFREZ (DOCETAXEL) Discontinued Drug: FDA Link

Adverse Drug Reactions for TAXOTERE* (Docetaxel)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with TAXOTERE
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Diarrhoea1906
2Nausea1592
3Neutropenia1538
4Dyspnoea1506
5Febrile neutropenia1493
6Pyrexia1432
7Vomiting1354
8Fatigue1169
9Death1104
10Dehydration1075
11Asthenia928
12Anaemia882
13Disease progression855
14Pneumonia794
15Pain787
16Neoplasm malignant710
17Abdominal pain706
18Decreased appetite684
19Hypotension657
20Osteonecrosis643

* This side effect also appears in "Top 10 Side Effects of TAXOTERE " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking TAXOTERE
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Breast cancer18736
2Prostate cancer6040
3Non-small cell lung cancer5080
4Breast cancer metastatic4829
5Product used for unknown indication3584
6Gastric cancer1462
7Lung neoplasm malignant1377
8Prostate cancer metastatic1339
9Neoplasm malignant1249
10Chemotherapy1183

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for TAXOTERE

Total Reports Filed with FDA: 102910


Number of FDA Adverse Event Reports by Patient Age for TAXOTERE

Total Reports Filed with FDA: 102910*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Docetaxel (Taxotere, Docefrez, Docetaxel, Txt)

Charts are based on 102910 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and TAXOTERE Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.