Pharmacologic class (EPC) · 7 drug pages

Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor: adverse event reports filed with FDA

29,070 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

29,070
reports across the class: 0.1% of all reports; 1,173
reports, 12 months to June 2026: 2,214 in the 12 months before; 79.6%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 29,070 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,173 reports arrived in the 12 months to June 2026, down 47% from 2,214 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 79.6% of the class's reports are marked serious, 11.5% record death among the outcomes and 17.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are virologic failure (8.1%), drug resistance (7.3%) and foetal exposure during pregnancy (6.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Efavirenz	generic	9,155	120	97.2%	Virologic failure
Nevirapine	generic	7,918	65	97.2%	Foetal exposure during pregnancy
Rilpivirine	generic	6,685	877	39.3%	Injection site pain
IntelenceEtravirine	brand	1,752	14	86.8%	Lipodystrophy acquired
Etravirine	generic	1,285	17	91.1%	Drug resistance
JulucaDolutegravir sodium and rilpivirine hydrochloride	brand	1,181	46	40.6%	Product dose omission issue
EdurantRilpivirine hydrochloride	brand	1,094	34	67.5%	Foetal exposure during pregnancy

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Virologic failure8.1%2,369
Drug resistance7.3%2,115
Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.7%1,934
Viral mutation identified5.9%1,714
Pathogen resistance4.9%1,425
Deaththe patient died; cause not stated by this term3.8%1,100
Drug interactionan interaction between medicines3.8%1,096
Treatment failurethe treatment did not work3.7%1,085
Exposure during pregnancythe medicine was taken during pregnancy3.5%1,019
Product dose omission issuea dose was missed3.4%992
Pyrexiafever2.9%841
Drug ineffectivethe medicine did not work as expected2.7%780
Lipodystrophy acquiredchanges in body fat distribution2.6%758
Maternal exposure during pregnancythe mother took the medicine during pregnancy2.6%751
Injection site painpain where the injection was given2.4%687
Anaemialow red blood cells2.3%678
Viral load increased2.3%661
Rashskin rash2.3%657
Depressionlow mood2.2%634
Off label useused for a purpose or in a way not on the label2.2%633
Nauseafeeling sick2%580
Treatment noncompliancethe treatment was not taken as directed2%571
Diarrhoealoose or frequent stools2%568
Vomitingbeing sick1.9%566
HIV infectionHIV infection1.9%549

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.5%3,350

Life-threatening3.3%958

Hospitalisation (initial or prolonged)17.1%4,977

Disability1.3%384

Congenital anomaly5.1%1,476

Other serious63.7%18,517

Not serious20.4%5,940

Patient age

Under 22.2%635

2 to 111%277

12 to 170.9%258

18 to 4421.7%6,294

45 to 6417.4%5,044

65 to 742.6%757

75 and over0.6%170

Age not given53.8%15,635

Who reported

Physician23.6%6,869

Pharmacist6.4%1,860

Other health professional48%13,943

Lawyer0%1

Consumer or non-health professional14.4%4,173

Not given7.7%2,224

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor reports

Which drugs are in the Human immunodeficiency virus 1 Non-Nucleoside analog reverse transcriptase inhibitor class on this site?

Efavirenz, Nevirapine, Rilpivirine, Intelence, Etravirine and Juluca and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

29,070 reports through June 2026, 1,173 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

virologic failure (8.1%), drug resistance (7.3%), foetal exposure during pregnancy (6.7%), viral mutation identified (5.9%) and pathogen resistance (4.9%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.