Isentress: adverse event reports filed with FDA

7,969

reports as suspect product

0% of all reports · about 421 a year

67

reports, 12 months to June 2026

103 in the 12 months before

74.7%

marked serious by the reporter

78.6% across the class

10.7%

record death among outcomes, as reported

853 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Isentress reports recording the termmedian drug in human immunodeficiency virus integrase strand transfer inhibitor

1. Foetal exposure during pregnancythe unborn baby was exposed to the medicine10%795
2. Maternal exposure during pregnancythe mother took the medicine during pregnancy7.6%608
3. Exposure during pregnancythe medicine was taken during pregnancy7.5%596
4. Drug interactionan interaction between medicines5.6%450
5. Depressionlow mood5.6%447
6. No adverse eventno adverse event was reported4.2%334
7. Deaththe patient died; cause not stated by this term3.6%290
8. Diarrhoealoose or frequent stools2.7%219
9. Nauseafeeling sick2.6%205
10. Premature babya baby born early2.5%203
11. Abortion spontaneousmiscarriage2.4%194
12. Off label useused for a purpose or in a way not on the label2.2%172
13. Anxietyanxiety2.1%170
14. Fatiguetiredness2.1%170
15. Alanine aminotransferase increasedraised liver enzyme (ALT)2.1%167
16. Rashskin rash2.1%166
17. Pyrexiafever2%160
18. Suicidal ideationthoughts of suicide1.9%150
19. Aspartate aminotransferase increasedraised liver enzyme (AST)1.9%149
20. Adverse eventan unwanted medical event, type not specified1.8%146
21. Dysphagiadifficulty swallowing1.8%143
22. Product use in unapproved indicationused for a purpose not on the label1.7%139
23. Anaemialow red blood cells1.7%132
24. Headachehead pain1.6%130
25. Vomitingbeing sick1.6%128
26. Lipodystrophy acquiredchanges in body fat distribution1.6%125
27. Renal failurekidney failure1.5%123
28. Insomniadifficulty sleeping1.5%119
29. Drug ineffectivethe medicine did not work as expected1.5%117
30. Paranoiaparanoia1.5%117

Top 30 of 1,224 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the human immunodeficiency virus integrase strand transfer inhibitor class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 17,985 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 44.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 7,969 reports.

Drugs most often listed in the same reports

Other products listed in reports where Isentress is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the human immunodeficiency virus integrase strand transfer inhibitor class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Isentress as a suspect or interacting product; reports listing it only as a concomitant medication (3,541) are excluded. 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.