Velaglucerase alfa adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Velaglucerase alfa
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Hydrolytic lysosomal glucocerebroside-specific enzyme

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From May 2010 to April 2026, FDA received 1,189 adverse event reports that name Velaglucerase alfa. In these reports the drug is a suspect or interacting product.

In the same period, 4 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 97 reports in the 12 months to June 2026 and 116 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 97 (under 0.1%) name Velaglucerase alfa. Reports from physicians were 38.7% of the reports that name Velaglucerase alfa and 21.9% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Velaglucerase alfa is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 9 reports that name Velaglucerase alfa.
In January to March 2026, FDA received 45.
In April to June 2025, FDA received 24.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 204 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,152 of the 1,189 reports (96.9%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 204 terms.

Reaction terms in the reports that name Velaglucerase alfa, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,189 reports
Inappropriate schedule of product administrationthe product was taken at the wrong times	188	15.8%
Product dose omission issuea dose was missed	187	15.7%
Covid-19COVID-19 infection	158	13.3%
Fatiguetiredness	112	9.4%
Weight increasedweight gain	98	8.2%
Malaisegeneral feeling of being unwell	90	7.6%
Falla fall	89	7.5%
Pyrexiafever	83	7%
Abdominal painstomach or belly pain	81	6.8%
Weight decreasedweight loss	80	6.7%
Deaththe patient died; cause not stated by this term	79	6.6%
Headachehead pain	76	6.4%
Nauseafeeling sick	72	6.1%
Arthralgiajoint pain	71	6%
Bone pain	69	5.8%
Blood pressure increaseda raised blood pressure reading	66	5.6%
Pneumonialung infection	63	5.3%
Product availability issuethe product was not available	60	5%
Painpain, site not specified	59	5%
Pain in extremitypain in an arm or leg	57	4.8%
Poor venous access	55	4.6%
Cough	54	4.5%
Product use issuea problem in how the product was used	51	4.3%
Back pain	50	4.2%
Diarrhoealoose or frequent stools	49	4.1%
Dizzinesslight-headedness or unsteadiness	48	4%
Vomitingbeing sick	48	4%
Nasopharyngitisa cold	47	4%
Influenzaflu	45	3.8%
Insurance issue	42	3.5%
Pregnancy	41	3.4%
Illness	39	3.3%
Incorrect dose administeredthe wrong dose was given	39	3.3%
Astheniaweakness or lack of energy	38	3.2%
Weight fluctuation	36	3%
Seizurea fit or convulsion	35	2.9%
Treatment noncompliancethe treatment was not taken as directed	33	2.8%
Exposure during pregnancythe medicine was taken during pregnancy	32	2.7%
Abdominal pain upperupper stomach pain	31	2.6%
Dyspnoeashortness of breath	31	2.6%
Oropharyngeal painsore throat	29	2.4%
Abortion spontaneousmiscarriage	27	2.3%
Urinary tract infectionbladder or urinary infection	27	2.3%
Infusion related reactiona reaction during or soon after an infusion	25	2.1%
Product distribution issue	25	2.1%
Chest pain	24	2%
Blood pressure decreaseda low blood pressure reading	22	1.9%
Product prescribing error	22	1.9%
Contusiona bruise	20	1.7%
Drug ineffectivethe medicine did not work as expected	20	1.7%

Download all 204 terms of Velaglucerase alfa (CSV)

The counts add to more than 1,189 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Velaglucerase alfa with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Velaglucerase alfa (this page)	Generic name	1,189
Vpriv	Brand name	825

Sum of the separately reported names: 2,014. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Velaglucerase alfa, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2010	5	5	1	0	3	1	0	1	0
2011	7	6	2	0	1	0	0	3	1
2012	2	2	0	0	1	0	0	1	0
2013	9	8	0	0	3	0	0	5	1
2014	5	5	0	0	5	0	0	0	0
2015	4	4	0	0	4	0	0	3	0
2017	5	5	1	0	2	0	0	4	0
2018	12	11	0	0	7	0	0	5	1
2019	19	18	4	1	10	0	0	11	1
2020	25	23	1	0	11	0	0	13	2
2021	190	181	26	14	125	3	1	144	9
2022	202	192	34	5	120	1	0	156	10
2023	171	162	35	12	93	4	0	135	9
2024	194	185	29	2	91	6	0	151	9
2025	253	237	28	9	145	4	1	198	16
2026	86	85	9	2	46	2	0	67	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Velaglucerase alfa, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Velaglucerase alfa, by the year in which FDA received them
Year	Reports
2010	5
2011	7
2012	3
2013	14
2014	13
2015	7
2016	5
2017	14
2018	48
2019	65
2020	111
2021	278
2022	203
2023	135
2024	136
2025	91
2026	54

Reports that name Velaglucerase alfa, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Velaglucerase alfa
Age	Reports	Share
Under 2	24	2%
2 to 11	78	6.6%
12 to 17	49	4.1%
18 to 44	243	20.4%
45 to 64	208	17.5%
65 to 74	127	10.7%
75 and over	101	8.5%
Age not given	359	30.2%

Sex of the patient in the reports that name Velaglucerase alfa
Sex	Reports	Share
Female	600	50.5%
Male	524	44.1%
Unknown or not given	65	5.5%

Type of reporter in the reports that name Velaglucerase alfa
Reporter	Reports	Share
Physician	460	38.7%
Pharmacist	7	0.6%
Other health professional	236	19.8%
Lawyer	0	0%
Consumer or non-health professional	485	40.8%
Not given	1	0.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 33.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Velaglucerase alfa record
Indication as recorded (MedDRA)	Reports	Share
Gaucher's disease	937	78.8%
Gaucher's disease type i	64	5.4%
Gaucher's disease type ii	17	1.4%
Fabry's disease	6	0.5%
Gaucher's disease type iii	5	0.4%
Immune system disorder	2	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,189 reports.

Drugs in the same reports

Other drugs that the reports of Velaglucerase alfa name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	44
Aspirin	45
Diphenhydramine	31
Epinephrine	60
Gabapentin	31
Omeprazole	34
Ramipril	30
Sodium chloride	61
Sterile water	49
Vitamin d	35

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Vpriv same ingredient
Imiglucerase same class
Elelyso same class
Cerezyme same class
Veklury next in the A to Z list
Velcade next in the A to Z list
Vedolizumab next in the A to Z list
Veletri next in the A to Z list
Vecuronium bromide next in the A to Z list
Veliparib next in the A to Z list
Vecuronium next in the A to Z list
Velmetia next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Velaglucerase alfaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Velaglucerase alfa: adverse event reports that FDA received. https://reportedreactions.com/drug/velaglucerase-alfa/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Velaglucerase alfa as a suspect or interacting product. The 4 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Velaglucerase alfa was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Velaglucerase alfa?

No. It is a count of what people reported to FDA: 1,189 reports from May 2010 to April 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Consumer or non-health professional (40.8%), physician (38.7%) and other health professional (19.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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