Mvasi: adverse event reports filed with FDA

4,508

reports as suspect product

0% of all reports · about 342 a year

542

reports, 12 months to June 2026

730 in the 12 months before

27.9%

marked serious by the reporter

87.6% across the class

2.4%

record death among outcomes, as reported

109 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 Mvasi reports recording the termmedian drug in vascular endothelial growth factor inhibitor

1. Off label useused for a purpose or in a way not on the label10.6%478
2. Product storage errorthe product was stored wrongly9.7%437
3. Circumstance or information capable of leading to medication errora situation that could lead to a medication error7.7%345
4. Hypertensionhigh blood pressure4.7%212
5. Disease progressionthe disease advanced4.2%189
6. Blood pressure increaseda raised blood pressure reading3.9%177
7. Product dose omission issuea dose was missed3.5%158
8. Adverse eventan unwanted medical event, type not specified3.2%143
9. Platelet count decreasedlow platelet count2.8%125
10. Fatiguetiredness2.5%113
11. Intercepted product administration error2.2%97
12. Malaisegeneral feeling of being unwell2%92
13. Nauseafeeling sick2%92
14. Ill-defined disordera condition that was not clearly described2%91
15. Accidental exposure to product2%89
16. Diarrhoealoose or frequent stools1.9%87
17. Unevaluable eventthe event could not be assessed1.6%73
18. Proteinuriaprotein in the urine1.5%69
19. Vomitingbeing sick1.5%69
20. Astheniaweakness or lack of energy1.5%66
21. Abdominal painstomach or belly pain1.4%64
22. Deaththe patient died; cause not stated by this term1.4%61
23. Dyspnoeashortness of breath1.3%60
24. Laboratory test abnormal1.3%60
25. Product preparation error1.3%60
26. Thrombocytopenialow platelets1.2%55
27. Intercepted product preparation error1.2%54
28. Neutrophil count decreased1.2%53
29. Refusal of treatment by patient1.1%50
30. Pyrexiafever1.1%49

Top 30 of 391 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 10 drugs in the vascular endothelial growth factor 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 176,429 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. 84.8% 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 4,508 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mvasi 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 vascular endothelial growth factor 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 Mvasi as a suspect or interacting product; reports listing it only as a concomitant medication (87) 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.