Pharmacologic class (EPC) · 4 drug pages

Human immunodeficiency virus integrase strand transfer inhibitor: adverse event reports filed with FDA

17,985 reports list a drug in this class as a suspect or interacting product, 2007–2026.

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.

17,985
reports across the class: 0.1% of all reports; 644
reports, 12 months to June 2026: 885 in the 12 months before; 78.6%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Human immunodeficiency virus integrase strand transfer inhibitor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 17,985 adverse event reports received by FDA, 0.1% of the database, from May 2007 to June 2026.

644 reports arrived in the 12 months to June 2026, down 27% from 885 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 78.6% of the class's reports are marked serious, 10.4% record death among the outcomes and 25.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are foetal exposure during pregnancy (8.7%), exposure during pregnancy (5.6%) and drug interaction (5.5%). 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
IsentressRaltegravir	brand	7,969	67	74.7%	Foetal exposure during pregnancy
TivicayDolutegravir sodium	brand	5,549	239	73.2%	Foetal exposure during pregnancy
Raltegravir	generic	3,199	82	97.1%	Drug interaction
VocabriaCabotegravir sodium	brand	1,268	256	79.1%	Injection site pain

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

Foetal exposure during pregnancythe unborn baby was exposed to the medicine8.7%1,557
Exposure during pregnancythe medicine was taken during pregnancy5.6%1,008
Drug interactionan interaction between medicines5.5%991
Maternal exposure during pregnancythe mother took the medicine during pregnancy5.5%990
Depressionlow mood4.8%861
Deaththe patient died; cause not stated by this term4.1%738
Virologic failure3.3%592
Nauseafeeling sick2.9%516
Off label useused for a purpose or in a way not on the label2.7%484
Diarrhoealoose or frequent stools2.5%453
Pathogen resistance2.5%451
Fatiguetiredness2.5%445
Rashskin rash2.5%444
Abortion spontaneousmiscarriage2.4%423
Pyrexiafever2.3%422
Headachehead pain2.3%416
Product dose omission issuea dose was missed2%367
No adverse eventno adverse event was reported2%353
Drug resistance1.9%341
Premature babya baby born early1.9%341
Viral mutation identified1.8%332
Drug ineffectivethe medicine did not work as expected1.8%319
Blood HIV RNA increased1.6%296
Immune reconstitution inflammatory syndrome1.6%292
Treatment noncompliancethe treatment was not taken as directed1.6%292

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.4%1,877

Life-threatening4.1%736

Hospitalisation (initial or prolonged)25.2%4,525

Disability2.6%461

Congenital anomaly7.3%1,321

Other serious60.1%10,815

Not serious21.4%3,857

Patient age

Under 23.2%576

2 to 110.5%89

12 to 170.6%115

18 to 4422%3,950

45 to 6425.4%4,573

65 to 743.8%689

75 and over0.9%165

Age not given43.5%7,828

Who reported

Physician30.8%5,533

Pharmacist8.4%1,511

Other health professional31.6%5,678

Lawyer0.2%28

Consumer or non-health professional26.8%4,826

Not given2.3%409

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 integrase strand transfer inhibitor reports

Which drugs are in the Human immunodeficiency virus integrase strand transfer inhibitor class on this site?

Isentress, Tivicay, Raltegravir and Vocabria. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

17,985 reports through June 2026, 644 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?

foetal exposure during pregnancy (8.7%), exposure during pregnancy (5.6%), drug interaction (5.5%), maternal exposure during pregnancy (5.5%) and depression (4.8%).

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.