Rilpivirine: adverse event reports filed with FDA

6,685

reports as suspect product

0% of all reports · about 443 a year

877

reports, 12 months to June 2026

1,666 in the 12 months before

39.3%

marked serious by the reporter

79.6% across the class

2.9%

record death among outcomes, as reported

195 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 Rilpivirine reports recording the termmedian drug in human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase inhibitor

1. Injection site painpain where the injection was given10%670
2. Product dose omission issuea dose was missed10%668
3. Viral load increased6.8%456
4. Virologic failure6.3%421
5. Pathogen resistance5.2%346
6. Painpain, site not specified4.5%303
7. Off label useused for a purpose or in a way not on the label4.2%284
8. Product use in unapproved therapeutic environment4.1%271
9. Viral mutation identified3.4%227
10. Blood HIV RNA increased3.2%217
11. Inappropriate schedule of product administrationthe product was taken at the wrong times2.7%182
12. Product complaint2.6%177
13. Product storage errorthe product was stored wrongly2.6%176
14. Pyrexiafever2.6%173
15. Treatment failurethe treatment did not work2.5%169
16. Exposure during pregnancythe medicine was taken during pregnancy2.5%168
17. Injection site nodule2.3%157
18. Fatiguetiredness2.3%154
19. Drug resistance2%135
20. Headachehead pain1.9%128
21. Nauseafeeling sick1.8%123
22. Depressionlow mood1.8%118
23. Condition aggravatedthe condition being treated got worse1.7%113
24. Dizzinesslight-headedness or unsteadiness1.6%106
25. Malaisegeneral feeling of being unwell1.6%106
26. Rashskin rash1.6%105
27. Myalgiamuscle pain1.6%104
28. Diarrhoealoose or frequent stools1.5%101
29. Drug interactionan interaction between medicines1.5%101
30. Wrong technique in device usage process1.5%101

Top 30 of 813 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 7 drugs in the human immunodeficiency virus 1 non-nucleoside analog reverse transcriptase 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 29,070 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. 67.9% 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 6,685 reports.

Drugs most often listed in the same reports

Other products listed in reports where Rilpivirine 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 1 non-nucleoside analog reverse transcriptase 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 Rilpivirine as a suspect or interacting product; reports listing it only as a concomitant medication (351) 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.