Complera: adverse event reports filed with FDA

6,535

reports as suspect product

0% of all reports · about 448 a year

95

reports, 12 months to June 2026

268 in the 12 months before

86.9%

marked serious by the reporter

84.3% across the class

1.3%

record death among outcomes, as reported

82 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 Complera reports recording the termmedian drug in human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor

1. Bone density decreased54.3%3,548
2. Renal injury45.3%2,959
3. Skeletal injury42.4%2,774
4. Tooth loss30.6%2,001
5. Chronic kidney diseaselong-term kidney disease30.4%1,987
6. Tooth injury30.2%1,976
7. Renal failurekidney failure24.8%1,618
8. Bone loss23.9%1,562
9. Multiple fractures23.2%1,515
10. Osteonecrosis23.2%1,515
11. Osteoporosisthinning of the bones21.1%1,379
12. Painpain, site not specified21.1%1,379
13. Emotional distressemotional distress20.9%1,365
14. Anxietyanxiety19.2%1,252
15. Anhedonia18.6%1,215
16. Osteopenia13.7%893
17. Acute kidney injurysudden loss of kidney function6.7%439
18. Blood creatinine increasedraised creatinine, a kidney test6.3%409
19. Economic problema financial problem6.1%400
20. Vitamin D deficiencylow vitamin D5.8%379
21. Renal impairmentreduced kidney function5%324
22. Nephropathy4.5%297
23. Fracturea broken bone3.2%208
24. Bone density abnormal3%198
25. Depressionlow mood3%194
26. Foot fracture2.9%190
27. Bone disorder2.7%175
28. Osteoarthritis2.4%158
29. Tooth fracture2.3%149
30. Ankle fracture2.1%137

Top 30 of 377 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 13 drugs in the human immunodeficiency virus 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 80,988 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. 99.2% 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 6,535 reports.

Drugs most often listed in the same reports

Other products listed in reports where Complera 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 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 Complera as a suspect or interacting product; reports listing it only as a concomitant medication (188) 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.