Darunavir: adverse event reports filed with FDA

4,460

reports as suspect product

0% of all reports · about 221 a year

86

reports, 12 months to June 2026

199 in the 12 months before

94.4%

marked serious by the reporter

88.5% across the class

12.4%

record death among outcomes, as reported

553 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 Darunavir reports recording the termmedian drug in protease inhibitor

1. Foetal exposure during pregnancythe unborn baby was exposed to the medicine10.7%479
2. Drug interactionan interaction between medicines10.7%477
3. Maternal exposure during pregnancythe mother took the medicine during pregnancy6.6%294
4. Virologic failure6.2%275
5. Drug resistance5.7%254
6. Exposure during pregnancythe medicine was taken during pregnancy5%222
7. Deaththe patient died; cause not stated by this term4.3%192
8. Off label useused for a purpose or in a way not on the label3.9%175
9. Treatment failurethe treatment did not work3.7%166
10. Pathogen resistance3.7%165
11. Treatment noncompliancethe treatment was not taken as directed3.7%163
12. Viral mutation identified3.6%161
13. Premature babya baby born early3.5%157
14. Abortion spontaneousmiscarriage3.4%151
15. Immune reconstitution inflammatory syndrome3.3%149
16. Drug ineffectivethe medicine did not work as expected3.2%144
17. Diarrhoealoose or frequent stools3.2%141
18. Lipodystrophy acquiredchanges in body fat distribution3.1%137
19. Toxicity to various agentspoisoning or toxic effect of one or more substances2.6%117
20. Renal impairmentreduced kidney function2.6%115
21. Nauseafeeling sick2.6%114
22. Acute kidney injurysudden loss of kidney function2.5%112
23. Vomitingbeing sick2.4%107
24. Pyrexiafever2.3%103
25. Eyelid ptosis2.2%96
26. Rashskin rash2.1%92
27. Mitochondrial toxicity2%90
28. Low birth weight baby2%89
29. Diplopiadouble vision2%88
30. CD4 lymphocytes decreased1.9%84

Top 30 of 980 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 6 drugs in the protease 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 22,331 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. 26.1% 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 4,460 reports.

Drugs most often listed in the same reports

Other products listed in reports where Darunavir 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 protease 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 Darunavir as a suspect or interacting product; reports listing it only as a concomitant medication (1,722) 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.