Nevirapine adverse event reports that FDA received

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

Name type: Generic name
Class: Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor
Also reported as: Nevirapine 200mg, Nevirapine 200mg Tablets, Nevirapine Tablets

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.

Reports on file

From January 2004 to June 2026, FDA received 7,918 adverse event reports that name Nevirapine. In these reports the drug is a suspect or interacting product.

In the same period, 1,306 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 65 reports in the 12 months to June 2026 and 95 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Nevirapine 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 32 reports that name Nevirapine.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 34.

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 612 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 7,880 of the 7,918 reports (99.5%).

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 612 terms.

Reaction terms in the reports that name Nevirapine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 7,918 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	1,084	13.7%
Drug resistance	1,025	12.9%
Virologic failure	794	10%
Viral mutation identified	684	8.6%
Deaththe patient died; cause not stated by this term	476	6%
Exposure during pregnancythe medicine was taken during pregnancy	460	5.8%
HIV infection	451	5.7%
Drug ineffectivethe medicine did not work as expected	392	5%
Pathogen resistance	349	4.4%
Treatment failurethe treatment did not work	314	4%
Drug exposure during pregnancythe medicine was taken during pregnancy	305	3.9%
Lipodystrophy acquiredchanges in body fat distribution	297	3.8%
Pyrexiafever	281	3.5%
Anaemialow red blood cells	241	3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	239	3%
Premature babya baby born early	229	2.9%
Stevens-Johnson syndromea severe skin and mucous-membrane reaction	193	2.4%
Rashskin rash	190	2.4%
Alanine aminotransferase increasedraised liver enzyme (ALT)	183	2.3%
Hepatotoxicityliver injury	170	2.1%
Vomitingbeing sick	168	2.1%
Immune reconstitution syndrome	167	2.1%
Eyelid ptosis	158	2%
Abortion spontaneousmiscarriage	155	2%
Drug interactionan interaction between medicines	154	1.9%
Aspartate aminotransferase increasedraised liver enzyme (AST)	149	1.9%
Mitochondrial toxicity	147	1.9%
Caesarean section	132	1.7%
Diplopiadouble vision	130	1.6%
Human immunodeficiency virus transmission	130	1.6%
Diarrhoealoose or frequent stools	128	1.6%
Exposure during breast feeding	125	1.6%
Treatment noncompliancethe treatment was not taken as directed	122	1.5%
Stillbirth	120	1.5%
Pneumonialung infection	118	1.5%
Maternal drugs affecting foetus	116	1.5%
Foetal exposure during delivery	112	1.4%
Premature delivery	104	1.3%
Nauseafeeling sick	103	1.3%
Off label useused for a purpose or in a way not on the label	100	1.3%
Ventricular septal defect	100	1.3%
Lactic acidosisa build-up of lactic acid in the blood	99	1.3%
Toxic epidermal necrolysisa severe skin reaction with peeling	89	1.1%
Developmental delayslower development in a child	84	1.1%
Immune reconstitution inflammatory syndrome	84	1.1%
Blood HIV RNA increased	83	1%
Neuropathy peripheralnerve damage in hands or feet	83	1%
Tuberculosis	83	1%
Fatiguetiredness	82	1%
Portal hypertension	82	1%

Download all 612 terms of Nevirapine (CSV)

The counts add to more than 7,918 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 Nevirapine, 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	263	259	29	8	54	5	18	187	4
2005	457	437	93	21	132	5	7	255	20
2006	348	344	61	9	52	9	11	252	4
2007	351	349	101	12	65	3	16	202	2
2008	367	366	84	14	65	4	13	262	1
2009	321	319	70	20	62	0	15	213	2
2010	221	220	66	8	41	2	16	141	1
2011	121	121	11	7	34	0	6	81	0
2012	131	131	15	6	49	0	5	86	0
2013	164	160	44	6	50	4	18	86	4
2014	218	216	52	4	60	3	38	113	2
2015	484	472	65	8	77	0	24	429	12
2016	834	819	208	10	72	3	50	680	15
2017	1,061	972	144	7	41	0	12	826	89
2018	428	420	20	8	38	3	26	395	8
2019	440	421	86	5	80	7	101	365	19
2020	516	501	36	17	45	6	101	452	15
2021	236	229	29	10	37	6	21	197	7
2022	304	298	40	6	54	3	101	278	6
2023	273	270	54	19	57	4	71	243	3
2024	192	189	25	11	51	3	38	156	3
2025	125	120	4	2	14	0	8	115	5
2026	63	63	31	2	36	0	23	56	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 Nevirapine, 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 Nevirapine, by the year in which FDA received them
Year	Reports
2004	239
2005	458
2006	366
2007	347
2008	388
2009	325
2010	238
2011	125
2012	155
2013	170
2014	228
2015	480
2016	833
2017	1,095
2018	465
2019	506
2020	494
2021	228
2022	274
2023	239
2024	143
2025	78
2026	42

Reports that name Nevirapine, 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 Nevirapine
Age	Reports	Share
Under 2	351	4.4%
2 to 11	135	1.7%
12 to 17	92	1.2%
18 to 44	1,392	17.6%
45 to 64	810	10.2%
65 to 74	89	1.1%
75 and over	33	0.4%
Age not given	5,016	63.3%

Sex of the patient in the reports that name Nevirapine
Sex	Reports	Share
Female	2,073	26.2%
Male	2,075	26.2%
Unknown or not given	3,770	47.6%

Type of reporter in the reports that name Nevirapine
Reporter	Reports	Share
Physician	1,383	17.5%
Pharmacist	67	0.8%
Other health professional	4,285	54.1%
Lawyer	0	0%
Consumer or non-health professional	520	6.6%
Not given	1,663	21%

Age and sex are as the report gives them. The reporter is the primary source in the report. 21.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Nevirapine record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	4,057	51.2%
Prophylaxis against HIV infection	821	10.4%
Antiretroviral therapy	399	5%
Human immunodeficiency virus transmission	223	2.8%
Prophylaxis	200	2.5%
Antiviral prophylaxis	128	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 7,918 reports.

Drugs in the same reports

Other drugs that the reports of Nevirapine name, in any role, in order of name
Drug	Reports that name the two
Abacavir	790
Didanosine	1,031
Efavirenz	1,067
Emtricitabine	612
Lamivudine	3,878
Ritonavir	831
Stavudine	1,682
Tenofovir	791
Tenofovir disoproxil fumarate	717
Zidovudine	3,070

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

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

Official pages

DailyMed labels for NevirapineThe 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. Nevirapine: adverse event reports that FDA received. https://reportedreactions.com/drug/nevirapine/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Nevirapine as a suspect or interacting product. The 1,306 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 Nevirapine 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 Nevirapine?

No. It is a count of what people reported to FDA: 7,918 reports from January 2004 to June 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 (54.1%), physician (17.5%) and consumer or non-health professional (6.6%). 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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