Kaletra: adverse event reports filed with FDA

9,419

reports as suspect product

0.1% of all reports · about 419 a year

57

reports, 12 months to June 2026

76 in the 12 months before

92.5%

marked serious by the reporter

87.2% across the class

15.1%

record death among outcomes, as reported

1,422 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 Kaletra reports recording the termmedian drug in cytochrome p450 3a inhibitor

1. Drug interactionan interaction between medicines12.7%1,200
2. Depressionlow mood9.8%920
3. Foetal exposure during pregnancythe unborn baby was exposed to the medicine6.8%640
4. Drug exposure during pregnancythe medicine was taken during pregnancy6.5%611
5. Diarrhoealoose or frequent stools6.3%593
6. Off label useused for a purpose or in a way not on the label5.5%516
7. Nauseafeeling sick4.7%441
8. Vomitingbeing sick3.9%370
9. Abortion spontaneousmiscarriage3.7%348
10. Pyrexiafever3.6%342
11. Exposure during pregnancythe medicine was taken during pregnancy3.1%290
12. Premature babya baby born early3.1%289
13. Anaemialow red blood cells3%284
14. Lipodystrophy acquiredchanges in body fat distribution2.7%253
15. Maternal exposure during pregnancythe mother took the medicine during pregnancy2.7%250
16. Loss of personal independence in daily activities2.4%230
17. Renal failurekidney failure2.3%218
18. Aspartate aminotransferase increasedraised liver enzyme (AST)2.1%197
19. Alanine aminotransferase increasedraised liver enzyme (ALT)2%190
20. Abdominal painstomach or belly pain1.9%179
21. Deaththe patient died; cause not stated by this term1.9%179
22. Weight decreasedweight loss1.9%177
23. Astheniaweakness or lack of energy1.9%175
24. Pneumonialung infection1.8%170
25. Abortion induced1.8%166
26. Anxietyanxiety1.8%166
27. Headachehead pain1.8%166
28. Mitochondrial toxicity1.8%165
29. Stillbirth1.7%164
30. Diplopiadouble vision1.7%161

Top 30 of 1,558 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 8 drugs in the cytochrome p450 3a 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 46,425 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. 23.3% 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 9,419 reports.

Drugs most often listed in the same reports

Other products listed in reports where Kaletra 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 cytochrome p450 3a 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 Kaletra as a suspect or interacting product; reports listing it only as a concomitant medication (3,411) 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.