Juluca: adverse event reports filed with FDA

1,181

reports as suspect product

0% of all reports · about 119 a year

46

reports, 12 months to June 2026

185 in the 12 months before

40.6%

marked serious by the reporter

79.6% across the class

6.7%

record death among outcomes, as reported

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

1. Product dose omission issuea dose was missed23.5%277
2. Fatiguetiredness4.2%50
3. Deaththe patient died; cause not stated by this term4.1%49
4. Product use issuea problem in how the product was used4.1%49
5. Rashskin rash3.6%42
6. Condition aggravatedthe condition being treated got worse3.4%40
7. Viral load increased3.4%40
8. Weight increasedweight gain3.2%38
9. Diarrhoealoose or frequent stools3%36
10. Headachehead pain3%36
11. Depressionlow mood2.5%30
12. Hypertensionhigh blood pressure2.4%28
13. Drug ineffectivethe medicine did not work as expected2.2%26
14. Painpain, site not specified2.2%26
15. Drug interactionan interaction between medicines2.1%25
16. Nauseafeeling sick2.1%25
17. Product storage errorthe product was stored wrongly2.1%25
18. Insomniadifficulty sleeping2%24
19. Malaisegeneral feeling of being unwell1.9%23
20. Anxietyanxiety1.8%21
21. Arthralgiajoint pain1.8%21
22. Hospitalisationadmission to hospital1.8%21
23. Off label useused for a purpose or in a way not on the label1.7%20
24. Weight decreasedweight loss1.7%20
25. Neuropathy peripheralnerve damage in hands or feet1.6%19
26. Pain in extremitypain in an arm or leg1.6%19
27. Pneumonialung infection1.5%18
28. Diabetes mellitusdiabetes1.4%17
29. Dyspepsiaindigestion1.4%17
30. Chronic kidney diseaselong-term kidney disease1.4%16

Top 30 of 283 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. 80.7% 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 1,181 reports.

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 Juluca as a suspect or interacting product; reports listing it only as a concomitant medication (562) 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.