Generic name
Lenacapavir: adverse event reports filed with FDA
611 reports list it as a suspect or interacting product, 2019–2026.
- 611
- reports as suspect product
- 0% of all reports · about 84 a year
- 243
- reports, 12 months to June 2026
- 180 in the 12 months before
- 34.5%
- marked serious by the reporter
- 57.4% across all reports
- 7.2%
- record death among outcomes, as reported
- 44 reports · not verified by FDA
Between April 2019 and June 2026, 611 adverse event reports received by FDA list lenacapavir, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (69) are left out of every figure here.
In the 12 months to June 2026, 243 reports listed it, up 35% from 180 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 84 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (22.7%), product use issue (16.4%) and product use in unapproved therapeutic environment (13.4%). A report can list several reactions, so shares add to more than 100%; 107 different terms appear across these reports. Off label use is recorded in 22.7% of these reports, against 4.1% of all reports in the database.
34.5% of the reports are marked serious by the reporter; 7.2% record death among the outcomes and 10.8% record hospitalisation, as reported. 36.7% of the reports came from physicians, and the largest patient age group is 45 to 64 (23.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Lenacapavir reports recording the termall reports in the database
- Off label useused for a purpose or in a way not on the label22.7%139
- Product use issuea problem in how the product was used16.4%100
- Product use in unapproved therapeutic environment13.4%82
- Injection site painpain where the injection was given8.5%52
- Injection site nodule7.2%44
- Injection site discharge5.1%31
- Deaththe patient died; cause not stated by this term4.7%29
- Injection site mass3.9%24
- Fatiguetiredness3.6%22
- Viral load increased3.6%22
- Exposure during pregnancythe medicine was taken during pregnancy3.4%21
- Nauseafeeling sick3.3%20
- Nodule2.9%18
- Painpain, site not specified2.6%16
- Injection site reactiona reaction where the injection was given2.5%15
- Injection site erythemaredness where the injection was given2.3%14
- Product dose omission issuea dose was missed2.3%14
- Virologic failure2.3%14
- Injection site swellingswelling where the injection was given2%12
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2%12
- Pathogen resistance1.6%10
- Drug ineffectivethe medicine did not work as expected1.5%9
- Single component of a two-component product administered1.5%9
- Blood HIV RNA increased1.3%8
- Blood pressure decreaseda low blood pressure reading1.3%8
- Dizzinesslight-headedness or unsteadiness1.3%8
- Labelled drug-drug interaction issue1.3%8
- Viral mutation identified1.3%8
- Blood creatinine increasedraised creatinine, a kidney test1.1%7
Top 30 of 107 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 share of all reports in the database; 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 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 81.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hiv infection | 342 | 56% |
| Prophylaxis against HIV infection | 14 | 2.3% |
| Hiv viraemia | 3 | 0.5% |
| Hiv-2 infection | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 611 reports.
In context
| Measure | Lenacapavir | All reports |
|---|---|---|
| Reports as suspect product | 611 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 243 | 1,332,454 |
| Marked serious | 34.5% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 72 | 91 |
| Hospitalisation recorded, per 1,000 reports | 108 | 213 |
| Consumer-filed share | 18.3% | 45.8% |
| Top term, share of reports | Off label use 22.7% | 4.1% |
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."
Questions about Lenacapavir reports
How many adverse event reports has FDA received for Lenacapavir?
611 reports list Lenacapavir as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 243 of them arrived in the latest 12 months. Another 69 list it only as a concomitant medication.
What reactions are recorded in Lenacapavir reports?
off label use (22.7%), product use issue (16.4%), product use in unapproved therapeutic environment (13.4%), labelled drug-drug interaction medication error (9.3%) and injection site pain (8.5%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Lenacapavir was responsible.
How serious are the reports?
34.5% are marked serious by the reporter. Among the outcomes recorded, 7.2% of reports include death and 10.8% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (36.7%), other health professional (26.2%) and pharmacist (18.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lenacapavir rising?
243 reports in the 12 months to June 2026, up 35% from 180 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Lenacapavir was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Lenacapavir?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Lenacapavir as a suspect or interacting product; reports listing it only as a concomitant medication (69) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.