Doxil: adverse event reports filed with FDA

4,921

reports as suspect product

0% of all reports · about 219 a year

28

reports, 12 months to June 2026

54 in the 12 months before

89.5%

marked serious by the reporter

97% across the class

15.2%

record death among outcomes, as reported

748 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 Doxil reports recording the termmedian drug in anthracycline topoisomerase inhibitor

1. Febrile neutropeniafever with low white blood cells7.6%376
2. Nauseafeeling sick6.5%320
3. Off label useused for a purpose or in a way not on the label5.6%275
4. Vomitingbeing sick5.3%262
5. Interstitial lung diseasescarring or inflammation of lung tissue5%245
6. Neutropenialow neutrophils, a type of white blood cell4.8%238
7. Fatiguetiredness4.6%227
8. Pyrexiafever4.5%220
9. Anaemialow red blood cells4.1%203
10. Dyspnoeashortness of breath3.8%189
11. Palmar-plantar erythrodysaesthesia syndrome3.8%186
12. Product use in unapproved indicationused for a purpose not on the label3.6%178
13. Disease progressionthe disease advanced3.4%166
14. Pneumonialung infection3.2%159
15. Deaththe patient died; cause not stated by this term3.1%155
16. Diarrhoealoose or frequent stools2.9%144
17. Sepsisa severe body-wide response to infection2.9%143
18. Thrombocytopenialow platelets2.9%142
19. Astheniaweakness or lack of energy2.9%141
20. Malignant neoplasm progression2.8%140
21. Pancytopenialow counts of all blood cells2.6%127
22. Back painback pain2.5%125
23. Infusion related reactiona reaction during or soon after an infusion2.4%117
24. Rashskin rash2.3%112
25. Abdominal painstomach or belly pain2.3%111
26. Pleural effusionfluid around the lung2.3%111
27. Stomatitissore mouth2.1%105
28. Drug ineffectivethe medicine did not work as expected2%98
29. Mucosal inflammation2%96
30. Neuropathy peripheralnerve damage in hands or feet2%96

Top 30 of 849 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 7 drugs in the anthracycline topoisomerase 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 109,832 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. 50.1% 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 4,921 reports.

Drugs most often listed in the same reports

Other products listed in reports where Doxil 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 anthracycline topoisomerase 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 Doxil as a suspect or interacting product; reports listing it only as a concomitant medication (1,955) 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.