Stavudine adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Stavudine Xr, Cap Stavudine, Stavudine Capsule

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 January 2004 to May 2026, FDA received 4,075 adverse event reports that name Stavudine. In these reports the drug is a suspect or interacting product.

In the same period, 859 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 26 reports in the 12 months to June 2026 and 41 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, 26 (under 0.1%) name Stavudine. Reports from other health professionals were 59.3% of the reports that name Stavudine and 19.7% 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 Stavudine 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 7 reports that name Stavudine.
In January to March 2026, FDA received 8.
In April to June 2025, FDA received 25.

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 432 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 4,060 of the 4,075 reports (99.6%).

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 432 terms.

Reaction terms in the reports that name Stavudine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,075 reports
Drug resistance	435	10.7%
Virologic failure	407	10%
Lipodystrophy acquiredchanges in body fat distribution	288	7.1%
Viral mutation identified	281	6.9%
Treatment failurethe treatment did not work	264	6.5%
Immune reconstitution syndrome	235	5.8%
Lactic acidosisa build-up of lactic acid in the blood	231	5.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	210	5.2%
Pathogen resistance	199	4.9%
Vomitingbeing sick	176	4.3%
Anaemialow red blood cells	167	4.1%
Mitochondrial toxicity	146	3.6%
Neuropathy peripheralnerve damage in hands or feet	135	3.3%
Pyrexiafever	125	3.1%
Immune reconstitution inflammatory syndrome	122	3%
Deaththe patient died; cause not stated by this term	120	2.9%
Eyelid ptosis	114	2.8%
Nauseafeeling sick	114	2.8%
Diarrhoealoose or frequent stools	105	2.6%
Drug interactionan interaction between medicines	103	2.5%
Pregnancy	101	2.5%
Alanine aminotransferase increasedraised liver enzyme (ALT)	95	2.3%
Aspartate aminotransferase increasedraised liver enzyme (AST)	92	2.3%
Diplopiadouble vision	91	2.2%
Portal hypertension	90	2.2%
Abdominal painstomach or belly pain	83	2%
Drug ineffectivethe medicine did not work as expected	82	2%
Exposure during pregnancythe medicine was taken during pregnancy	79	1.9%
Multiple-drug resistance	78	1.9%
Drug exposure during pregnancythe medicine was taken during pregnancy	77	1.9%
Treatment noncompliancethe treatment was not taken as directed	74	1.8%
Weight decreasedweight loss	74	1.8%
Hepatic fibrosis	72	1.8%
Hyperlactacidaemia	68	1.7%
Premature babya baby born early	68	1.7%
Myalgiamuscle pain	67	1.6%
Drug-induced liver injury	64	1.6%
Dysphagiadifficulty swallowing	63	1.5%
Dyspnoeashortness of breath	63	1.5%
Hepatic steatosisfatty liver	61	1.5%
Pancreatitisinflammation of the pancreas	60	1.5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	59	1.4%
Astheniaweakness or lack of energy	57	1.4%
Blood lactic acid increased	57	1.4%
Fatiguetiredness	57	1.4%
Lymphadenopathyswollen lymph nodes	57	1.4%
Condition aggravatedthe condition being treated got worse	52	1.3%
Tuberculosis	52	1.3%
Blood bilirubin increased	51	1.3%
Headachehead pain	51	1.3%

Download all 432 terms of Stavudine (CSV)

The counts add to more than 4,075 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 Stavudine, 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
2004	334	321	57	35	133	19	2	153	13
2005	261	248	57	6	93	9	2	140	13
2006	240	239	59	6	57	3	2	164	1
2007	188	186	35	11	59	4	7	105	2
2008	204	198	44	8	71	6	9	116	6
2009	243	238	34	12	71	8	7	166	5
2010	124	124	34	1	50	1	4	80	0
2011	103	102	3	12	29	0	3	78	1
2012	104	102	11	5	36	0	4	65	2
2013	130	128	36	4	33	5	6	83	2
2014	139	139	28	2	31	0	23	76	0
2015	307	287	45	2	26	2	37	273	20
2016	424	421	70	3	27	2	40	372	3
2017	374	362	53	8	42	2	1	319	12
2018	226	224	16	18	19	0	8	214	2
2019	129	127	4	14	22	6	3	124	2
2020	146	144	6	4	19	1	6	137	2
2021	75	74	6	5	18	0	1	72	1
2022	77	75	7	4	12	0	1	73	2
2023	114	113	8	4	17	0	2	111	1
2024	30	30	2	0	7	0	1	30	0
2025	74	74	5	2	14	0	3	73	0
2026	29	29	3	0	5	1	0	28	0

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 Stavudine, 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 Stavudine, by the year in which FDA received them
Year	Reports
2004	300
2005	280
2006	265
2007	203
2008	222
2009	249
2010	142
2011	108
2012	110
2013	137
2014	145
2015	286
2016	387
2017	378
2018	249
2019	138
2020	140
2021	73
2022	76
2023	96
2024	16
2025	43
2026	15

Reports that name Stavudine, 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 Stavudine
Age	Reports	Share
Under 2	141	3.5%
2 to 11	118	2.9%
12 to 17	109	2.7%
18 to 44	1,337	32.8%
45 to 64	702	17.2%
65 to 74	47	1.2%
75 and over	8	0.2%
Age not given	1,613	39.6%

Sex of the patient in the reports that name Stavudine
Sex	Reports	Share
Female	1,211	29.7%
Male	1,657	40.7%
Unknown or not given	1,207	29.6%

Type of reporter in the reports that name Stavudine
Reporter	Reports	Share
Physician	641	15.7%
Pharmacist	30	0.7%
Other health professional	2,416	59.3%
Lawyer	0	0%
Consumer or non-health professional	372	9.1%
Not given	616	15.1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 22.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Stavudine record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	2,785	68.3%
Antiretroviral therapy	289	7.1%
Acquired immunodeficiency syndrome	60	1.5%
Prophylaxis against HIV infection	37	0.9%
Hiv test positive	29	0.7%
Retroviral infection	21	0.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,075 reports.

Drugs in the same reports

Other drugs that the reports of Stavudine name, in any role, in order of name
Drug	Reports that name the two
Abacavir	606
Didanosine	1,260
Efavirenz	1,466
Lamivudine	2,917
Lopinavir	387
Nevirapine	1,638
Ritonavir	740
Tenofovir	405
Tenofovir disoproxil fumarate	331
Zidovudine	1,224

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 StavudineThe 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. Stavudine: adverse event reports that FDA received. https://reportedreactions.com/drug/stavudine/ 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 Stavudine as a suspect or interacting product. The 859 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 Stavudine 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 Stavudine?

No. It is a count of what people reported to FDA: 4,075 reports from January 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?

Other health professional (59.3%), physician (15.7%) and consumer or non-health professional (9.1%). 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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