Kaletralopinavir + ritonavir
13,447 adverse event reports submitted to the FDA (2002–2026)
Top Reported Adverse Events
The most frequently reported events in association with Kaletra in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Drug Interaction 1,334 reports
A report that two or more medications may have affected each other when taken together.
Full definition in the glossary →Depression 1,133 reports
A persistent low mood, loss of interest, or feelings of sadness. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary → See all drugs reporting this event →Nausea 781 reports
The feeling of sickness in your stomach that often comes before vomiting.
Full definition in the glossary → See all drugs reporting this event →Drug Exposure During Pregnancy 779 reports
A report noting that a person was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself.
Full definition in the glossary →Diarrhoea 775 reports
Loose or watery bowel movements, often frequent. Also spelled diarrhea in American English.
Full definition in the glossary → See all drugs reporting this event →Foetal Exposure During Pregnancy 750 reports
A report noting that a developing baby was exposed to a medication during pregnancy. This is a tracking category for monitoring, not a description of harm by itself. Also spelled fetal in American English.
Full definition in the glossary →Anxiety 713 reports
A feeling of worry, nervousness, or unease.
Full definition in the glossary → See all drugs reporting this event →Vomiting 701 reports
Throwing up the contents of the stomach.
Full definition in the glossary → See all drugs reporting this event →Pain 694 reports
A general report of physical discomfort, used when no more specific location is given.
Full definition in the glossary →Off Label Use 675 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Emotional Distress 578 reports
A report of emotional suffering such as upset, worry, or anguish. If you are struggling, the 988 Suicide and Crisis Lifeline (call or text 988 in the US) is available 24 hours a day.
Full definition in the glossary →Renal Failure 541 reports
A serious decline in kidney function, where the kidneys can no longer filter waste properly.
Full definition in the glossary →Pyrexia 526 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →Anhedonia 510 reports
A reduced ability to feel pleasure or interest in activities once enjoyed.
Full definition in the glossary →Anaemia 450 reports
A condition where there are too few healthy red blood cells to carry enough oxygen, often causing tiredness and paleness. Also spelled anemia in American English.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Male | 7,699 |
| Female | 4,478 |
| Unknown | 73 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 572 |
| 18-34 | 1,528 |
| 35-49 | 2,618 |
| 50-64 | 2,690 |
| 65-74 | 470 |
| 75+ | 227 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Kaletra. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Other Serious | 7,462 |
| Hospitalization | 4,982 |
| Death | 1,766 |
| Non-Serious | 1,073 |
| Life-Threatening | 748 |
| Disability | 390 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Kaletra. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2002 | 1 |
| 2003 | 4 |
| 2004 | 762 |
| 2005 | 608 |
| 2006 | 677 |
| 2007 | 725 |
| 2008 | 999 |
| 2009 | 1,056 |
| 2010 | 922 |
| 2011 | 629 |
| 2012 | 681 |
| 2013 | 469 |
| 2014 | 575 |
| 2015 | 587 |
| 2016 | 407 |
| 2017 | 268 |
| 2018 | 312 |
| 2019 | 427 |
| 2020 | 1,445 |
| 2021 | 863 |
| 2022 | 473 |
| 2023 | 217 |
| 2024 | 137 |
| 2025 | 177 |
| 2026 (partial) | 26 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Kaletra
In FDA adverse event reports that mention Kaletra, these medications appeared most often in the same report.
- Lamivudine (3,862 reports)
- Emtricitabine And Tenofovir Disoproxil (2,841 reports)
- Tenofovir Disoproxil (2,342 reports)
- Lamivudine And Zidovudine (2,121 reports)
- Zidovudine (1,822 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026