Drugs › Human immunodeficiency virus integrase strand transfer inhibitor
Brand name · Cabotegravir sodium
Vocabria: adverse event reports filed with FDA
1,268 reports list it as a suspect or interacting product, 2016–2026. Class: Human immunodeficiency virus integrase strand transfer inhibitor.
- 1,268
- reports as suspect product
- 0% of all reports · about 128 a year
- 256
- reports, 12 months to June 2026
- 319 in the 12 months before
- 79.1%
- marked serious by the reporter
- 78.6% across the class
- 6.5%
- record death among outcomes, as reported
- 83 reports · not verified by FDA
1,268 adverse event reports received by FDA list the brand name Vocabria (cabotegravir sodium) as a suspect or interacting product, from August 2016 to June 2026. A further 254 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 256 reports listed it, down 20% from 319 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 128 reports a year and 0% of the 20,646,523 reports in the database, and 7.1% of the reports for the human immunodeficiency virus integrase strand transfer inhibitor class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded injection site pain (6.4%), hepatitis B (4.8%) and pathogen resistance (4.6%). A report can list several reactions, so shares add to more than 100%; 519 different terms appear across these reports. Injection site pain is recorded in 6.4% of these reports, with no counterpart in the median human immunodeficiency virus integrase strand transfer inhibitor drug (0%).
79.1% of the reports are marked serious by the reporter (78.6% across the class); 6.5% record death among the outcomes and 12.5% record hospitalisation, as reported. 53.9% of the reports came from physicians, and the largest patient age group is 18 to 44 (20.3%). 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 Vocabria reports recording the termmedian drug in human immunodeficiency virus integrase strand transfer inhibitor
- Injection site painpain where the injection was given6.4%81
- Hepatitis Bhepatitis B infection4.8%61
- Pathogen resistance4.6%58
- Viral load increased4.5%57
- Off label useused for a purpose or in a way not on the label4.4%56
- Hepatitis B reactivation4.2%53
- Virologic failure4.2%53
- Rashskin rash3.6%46
- Nauseafeeling sick3.5%45
- Malaisegeneral feeling of being unwell3.2%41
- Syncopefainting3.2%40
- Fatiguetiredness3%38
- Dyspnoeashortness of breath2.8%36
- Headachehead pain2.8%36
- Painpain, site not specified2.8%35
- Product use issuea problem in how the product was used2.6%33
- Pyrexiafever2.6%33
- Depressionlow mood2.5%32
- Viral mutation identified2.4%31
- Product dose omission issuea dose was missed2.3%29
- Blood HIV RNA increased2.1%27
- Myalgiamuscle pain2.1%27
- Product use in unapproved therapeutic environment2.1%27
- Deaththe patient died; cause not stated by this term2.1%26
- Exposure during pregnancythe medicine was taken during pregnancy2.1%26
- Suicidal ideationthoughts of suicide2.1%26
- Erectile dysfunctiondifficulty getting or keeping an erection1.8%23
- Astheniaweakness or lack of energy1.7%22
- Hyperhidrosisexcessive sweating1.7%22
- Back painback pain1.7%21
Top 30 of 519 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
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. 26% 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 | 616 | 48.6% |
| Prophylaxis against HIV infection | 27 | 2.1% |
| Antiretroviral therapy | 21 | 1.7% |
| Hiv test positive | 14 | 1.1% |
| Antiviral treatment | 10 | 0.8% |
| Hiv test | 10 | 0.8% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,268 reports.
In context
| Measure | Vocabria | Human immunodeficiency virus integrase strand transfer inhibitor | All reports |
|---|---|---|---|
| Reports as suspect product | 1,268 | 17,985 | 20,646,523 |
| Share of that pool | — | 7.1% | 0% |
| Reports, latest 12 months | 256 | — | 1,332,454 |
| Marked serious | 79.1% | 78.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 65 | 104 | 91 |
| Hospitalisation recorded, per 1,000 reports | 125 | 252 | 213 |
| Consumer-filed share | 8.1% | 26.8% | 45.8% |
| Top term, share of reports | Injection site pain 6.4% | median 0% | 1.4% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Isentress | brand | 7,969 | 67 | 74.7% |
| Tivicay | brand | 5,549 | 239 | 73.2% |
| Raltegravir | generic | 3,199 | 82 | 97.1% |
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.
Questions about Vocabria reports
How many adverse event reports has FDA received for Vocabria?
1,268 reports list Vocabria as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 256 of them arrived in the latest 12 months. Another 254 list it only as a concomitant medication.
What reactions are recorded in Vocabria reports?
injection site pain (6.4%), hepatitis B (4.8%), pathogen resistance (4.6%), viral load increased (4.5%) and off label use (4.4%). 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 Vocabria was responsible.
How serious are the reports?
79.1% are marked serious by the reporter. Among the outcomes recorded, 6.5% of reports include death and 12.5% 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 (53.9%), other health professional (21.2%) and pharmacist (16.6%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Vocabria rising?
256 reports in the 12 months to June 2026, down 20% from 319 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 Vocabria 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 Vocabria?
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 Vocabria as a suspect or interacting product; reports listing it only as a concomitant medication (254) 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.