Zavesca (miglustat) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Miglustat

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 April 2004 to May 2026, FDA received 867 adverse event reports that name Zavesca. In these reports the drug is a suspect or interacting product.

In the same period, 37 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 3 reports in the 12 months to June 2026 and 5 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, 3 (under 0.1%) name Zavesca. Reports from physicians were 63.3% of the reports that name Zavesca 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 Zavesca 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 3 reports that name Zavesca.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 1.

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 81 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 793 of the 867 reports (91.5%).

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 81 terms.

Reaction terms in the reports that name Zavesca, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 867 reports
Deaththe patient died; cause not stated by this term	143	16.5%
Diarrhoealoose or frequent stools	130	15%
Niemann-Pick disease	89	10.3%
Seizurea fit or convulsion	88	10.1%
Weight decreasedweight loss	80	9.2%
Disease progressionthe disease advanced	70	8.1%
Condition aggravatedthe condition being treated got worse	63	7.3%
Pneumonialung infection	62	7.2%
Tremorshaking	60	6.9%
Dysphagiadifficulty swallowing	53	6.1%
Off label useused for a purpose or in a way not on the label	49	5.7%
Pyrexiafever	43	5%
Product use issuea problem in how the product was used	38	4.4%
Convulsion	35	4%
Epilepsy	34	3.9%
Vomitingbeing sick	33	3.8%
Thrombocytopenialow platelets	31	3.6%
Pneumonia aspirationlung infection from breathing in material	30	3.5%
Concomitant disease aggravated	29	3.3%
Astheniaweakness or lack of energy	27	3.1%
General physical health deteriorationgeneral decline in health	25	2.9%
Respiratory failurethe lungs could not supply enough oxygen	24	2.8%
Gastrostomy	23	2.7%
Falla fall	21	2.4%
Ataxia	20	2.3%
Gastrointestinal disorder	19	2.2%
Drug ineffectivethe medicine did not work as expected	17	2%
Fatiguetiredness	17	2%
Gait disturbancedifficulty walking	17	2%
Abdominal painstomach or belly pain	16	1.8%
Dyspnoeashortness of breath	16	1.8%
Sepsisa severe body-wide response to infection	15	1.7%
Constipation	14	1.6%
Dehydration	14	1.6%
Headachehead pain	14	1.6%
Malaisegeneral feeling of being unwell	14	1.6%
Decreased appetitereduced appetite	13	1.5%
Neurological decompensation	13	1.5%
Neuropathy peripheralnerve damage in hands or feet	13	1.5%
Growth retardation	12	1.4%
Urinary tract infectionbladder or urinary infection	12	1.4%
Cough	11	1.3%
Platelet count decreasedlow platelet count	11	1.3%
Abdominal distensiona bloated abdomen	10	1.2%
Drug dose omissiona dose was missed	10	1.2%
Influenzaflu	10	1.2%
Flatulencewind	9	1%
Gastrointestinal tube insertion	9	1%
Product supply issue	9	1%
Respiratory tract infectiona respiratory infection	9	1%

Download all 81 terms of Zavesca (CSV)

The counts add to more than 867 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.

Outcomes by year

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

Outcomes in the reports that name Zavesca, 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	Other Serious (Important Medical Events)	Not serious
2004	10	4	0	0	2	0	2	6
2005	14	9	1	1	3	2	5	5
2006	9	8	2	0	2	4	5	1
2007	10	9	0	1	5	0	6	1
2008	8	8	1	0	2	1	5	0
2009	8	7	1	0	4	1	6	1
2010	45	43	16	1	15	3	24	2
2011	39	37	13	1	7	5	20	2
2012	73	71	22	2	20	4	42	2
2013	61	58	24	0	19	6	31	3
2014	48	47	14	0	17	2	31	1
2015	86	77	18	2	41	4	34	9
2016	72	63	15	0	26	5	31	9
2017	94	88	23	3	37	2	47	6
2018	77	68	25	0	36	1	21	9
2019	34	32	10	0	25	1	5	2
2020	50	47	9	0	26	8	24	3
2021	100	99	83	0	6	0	14	1
2022	7	7	2	0	3	0	3	0
2023	11	8	2	0	5	1	2	3
2024	3	2	1	0	1	0	0	1
2025	5	3	2	1	2	0	1	2
2026	3	2	2	0	0	0	0	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 Zavesca, 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 Zavesca, by the year in which FDA received them
Year	Reports
2004	10
2005	13
2006	10
2007	9
2008	9
2009	6
2010	51
2011	51
2012	82
2013	65
2014	51
2015	85
2016	72
2017	79
2018	70
2019	38
2020	39
2021	99
2022	7
2023	11
2024	4
2025	3
2026	3

Reports that name Zavesca, 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 Zavesca
Age	Reports	Share
Under 2	33	3.8%
2 to 11	215	24.8%
12 to 17	118	13.6%
18 to 44	178	20.5%
45 to 64	64	7.4%
65 to 74	22	2.5%
75 and over	5	0.6%
Age not given	232	26.8%

Sex of the patient in the reports that name Zavesca
Sex	Reports	Share
Female	387	44.6%
Male	341	39.3%
Unknown or not given	139	16%

Type of reporter in the reports that name Zavesca
Reporter	Reports	Share
Physician	549	63.3%
Pharmacist	52	6%
Other health professional	156	18%
Lawyer	0	0%
Consumer or non-health professional	75	8.7%
Not given	35	4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Zavesca record
Indication as recorded (MedDRA)	Reports	Share
Niemann-pick disease	406	46.8%
Gaucher's disease	63	7.3%
Lipidosis	61	7%
Gaucher's disease	43	5%
Tay-sachs disease	19	2.2%
Gaucher's disease type i	18	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 867 reports.

Drugs in the same reports

Other drugs that the reports of Zavesca name, in any role, in order of name
Drug	Reports that name the two
Cerezyme	16
Clonazepam	15
Diazepam	17
Keppra	50
Lamictal	15
Levetiracetam	16
MiraLAX	23
Onfi	17
Vimpat	15
Vitamin d	17

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.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for ZavescaThe 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. Zavesca: adverse event reports that FDA received. https://reportedreactions.com/drug/zavesca/ 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 Zavesca as a suspect or interacting product. The 37 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 Zavesca 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 Zavesca?

No. It is a count of what people reported to FDA: 867 reports from April 2004 to May 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?

Physician (63.3%), other health professional (18%) and consumer or non-health professional (8.7%). 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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