Abraxane: adverse event reports filed with FDA

15,105

reports as suspect product

0.1% of all reports · about 711 a year

483

reports, 12 months to June 2026

533 in the 12 months before

93.8%

marked serious by the reporter

88.7% across the class

29.5%

record death among outcomes, as reported

4,449 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Abraxane reports recording the termmedian drug in microtubule inhibitor

1. Deaththe patient died; cause not stated by this term13.6%2,052
2. Neutropenialow neutrophils, a type of white blood cell5.8%883
3. Anaemialow red blood cells5.2%793
4. Diarrhoealoose or frequent stools5.2%782
5. Nauseafeeling sick5.1%769
6. Pyrexiafever4.6%694
7. Fatiguetiredness4.5%678
8. Thrombocytopenialow platelets4.5%676
9. Vomitingbeing sick4.2%627
10. Off label useused for a purpose or in a way not on the label4%610
11. Febrile neutropeniafever with low white blood cells4%605
12. Neuropathy peripheralnerve damage in hands or feet3.9%586
13. Pneumonialung infection3.1%462
14. Sepsisa severe body-wide response to infection3%449
15. Malignant neoplasm progression2.9%440
16. Leukopenialow white blood cells2.9%436
17. Dyspnoeashortness of breath2.8%430
18. Decreased appetitereduced appetite2.6%394
19. Abdominal painstomach or belly pain2.5%372
20. Astheniaweakness or lack of energy2.4%366
21. Pancreatic carcinoma2.3%343
22. Alopeciahair loss2.3%340
23. Dehydrationdehydration2.2%329
24. Neutrophil count decreased2.2%329
25. Disease progressionthe disease advanced2.1%313
26. Interstitial lung diseasescarring or inflammation of lung tissue2%300
27. White blood cell count decreasedlow white cell count1.9%291
28. General physical health deteriorationgeneral decline in health1.8%270
29. Pancreatic carcinoma metastatic1.7%262
30. Painpain, site not specified1.7%258

Top 30 of 1,138 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the microtubule inhibitor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 147,067 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 38.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 15,105 reports.

Drugs most often listed in the same reports

Other products listed in reports where Abraxane is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the microtubule inhibitor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Abraxane as a suspect or interacting product; reports listing it only as a concomitant medication (1,873) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.