Drug Safety Information for TAXOL (Paclitaxel)

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

Adverse Drug Reactions for TAXOL* (Paclitaxel)

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 TAXOL
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Dyspnoea2350
2Nausea2314
3Vomiting1899
4Death1878
5Diarrhoea1742
6Neutropenia1642
7Pyrexia1615
8Fatigue*1545
9Dehydration1442
10Anaemia1402
11Febrile neutropenia1189
12Asthenia1165
13Neoplasm malignant1027
14Disease progression1023
15Pneumonia953
16Neuropathy peripheral*894
17White blood cell count decreased887
18Abdominal pain884
19Pain*882
20Decreased appetite879

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

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

Reason # of FDA Reports
1Breast cancer*15605
2Non-small cell lung cancer8373
3Breast cancer metastatic*7488
4Ovarian cancer5838
5Product used for unknown indication4648
6Lung neoplasm malignant2244
7Chemotherapy1486
8Pancreatic carcinoma1262
9Ovarian epithelial cancer1158
10Pancreatic carcinoma metastatic1028

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


Types of Adverse Events for TAXOL

Total Reports Filed with FDA: 125429


Number of FDA Adverse Event Reports by Patient Age for TAXOL

Total Reports Filed with FDA: 125429*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Paclitaxel (Paxene, Anzatax, Abraxane, Onxol, Taxol, Paclitaxel)

Charts are based on 125429 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 TAXOL 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.