Vpriv: adverse event reports filed with FDA

825

reports as suspect product

0% of all reports · about 52 a year

21

reports, 12 months to June 2026

31 in the 12 months before

68.6%

marked serious by the reporter

74.5% across the class

12.7%

record death among outcomes, as reported

105 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 Vpriv reports recording the termmedian drug in hydrolytic lysosomal glucocerebroside-specific enzyme

1. Infusion related reactiona reaction during or soon after an infusion8.4%69
2. No adverse eventno adverse event was reported5.8%48
3. Deaththe patient died; cause not stated by this term5.2%43
4. Fatiguetiredness4.4%36
5. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.4%28
6. Headachehead pain3.2%26
7. Pyrexiafever3%25
8. Inappropriate schedule of product administrationthe product was taken at the wrong times2.7%22
9. Nauseafeeling sick2.5%21
10. Dyspnoeashortness of breath2.3%19
11. Falla fall2.3%19
12. Arthralgiajoint pain2.2%18
13. Pain in extremitypain in an arm or leg2.2%18
14. Product use issuea problem in how the product was used2.2%18
15. Drug ineffectivethe medicine did not work as expected2.1%17
16. Pneumonialung infection2.1%17
17. Back painback pain1.8%15
18. Bone painbone pain1.8%15
19. Malaisegeneral feeling of being unwell1.8%15
20. Maternal exposure during pregnancythe mother took the medicine during pregnancy1.8%15
21. Exposure during pregnancythe medicine was taken during pregnancy1.7%14
22. Coughcough1.6%13
23. Nasopharyngitisa cold1.6%13
24. Cerebrovascular accidentstroke1.3%11
25. Vomitingbeing sick1.3%11
26. Dizzinesslight-headedness or unsteadiness1.2%10
27. Hospitalisationadmission to hospital1.2%10
28. Off label useused for a purpose or in a way not on the label1.2%10
29. Abdominal painstomach or belly pain1.1%9
30. Hypersensitivityan allergic-type reaction1.1%9

Top 30 of 194 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 3 drugs in the hydrolytic lysosomal glucocerebroside-specific enzyme 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 6,362 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. 62.4% 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 825 reports.

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 hydrolytic lysosomal glucocerebroside-specific enzyme 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 Vpriv as a suspect or interacting product; reports listing it only as a concomitant medication (32) 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.