Perjeta: adverse event reports filed with FDA

12,939

reports as suspect product

0.1% of all reports · about 924 a year

643

reports, 12 months to June 2026

1,174 in the 12 months before

77.7%

marked serious by the reporter

86.6% across the class

10.1%

record death among outcomes, as reported

1,304 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 Perjeta reports recording the termmedian drug in her2/neu receptor antagonist

1. Diarrhoealoose or frequent stools13.5%1,753
2. Myelosuppression6.7%873
3. Nauseafeeling sick6.3%821
4. Fatiguetiredness6.1%788
5. Deaththe patient died; cause not stated by this term5.7%736
6. Off label useused for a purpose or in a way not on the label5.5%711
7. Rashskin rash4.5%582
8. No adverse eventno adverse event was reported4.4%574
9. Dyspnoeashortness of breath4.1%532
10. Vomitingbeing sick4%514
11. Disease progressionthe disease advanced3.9%500
12. Pyrexiafever3.7%475
13. Neuropathy peripheralnerve damage in hands or feet3.2%413
14. Astheniaweakness or lack of energy3.2%408
15. Alopeciahair loss2.9%381
16. Weight decreasedweight loss2.7%349
17. Chillschills or shivering2.6%342
18. Headachehead pain2.6%337
19. Painpain, site not specified2.4%308
20. Pruritusitching2.4%308
21. Ejection fraction decreased2.2%288
22. Drug ineffectivethe medicine did not work as expected2.2%282
23. Anaemialow red blood cells2.2%280
24. Febrile neutropeniafever with low white blood cells2.1%271
25. Pneumonialung infection2.1%269
26. Metastases to central nervous system2.1%268
27. Malaisegeneral feeling of being unwell2.1%267
28. White blood cell count decreasedlow white cell count2%265
29. Infusion related reactiona reaction during or soon after an infusion2%261
30. Platelet count decreasedlow platelet count2%259

Top 30 of 1,232 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 6 drugs in the her2/neu receptor antagonist 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 85,553 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. 32.8% 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 12,939 reports.

Drugs most often listed in the same reports

Other products listed in reports where Perjeta 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 her2/neu receptor antagonist 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 Perjeta as a suspect or interacting product; reports listing it only as a concomitant medication (1,331) 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.