Kaletra (lopinavir and ritonavir) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Kaletra
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Lopinavir and ritonavir
Class: Cytochrome P450 3A inhibitor
Also reported as: Kaletra /01399701/, Kaletra /01506501/, Kaletra Tablets

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 9,419 adverse event reports that name Kaletra. In these reports the drug is a suspect or interacting product.

In the same period, 3,411 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 57 reports in the 12 months to June 2026 and 76 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 57 (under 0.1%) name Kaletra. Reports from consumers or other non-health professionals were 13.6% of the reports that name Kaletra and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Kaletra is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 21 reports that name Kaletra.
In January to March 2026, FDA received 16.
In April to June 2025, FDA received 15.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 784 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 9,401 of the 9,419 reports (99.8%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 784 terms.

Reaction terms in the reports that name Kaletra, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 9,419 reports
Drug interactionan interaction between medicines	1,200	12.7%
Depressionlow mood	920	9.8%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	640	6.8%
Drug exposure during pregnancythe medicine was taken during pregnancy	611	6.5%
Diarrhoealoose or frequent stools	593	6.3%
Off label useused for a purpose or in a way not on the label	516	5.5%
Nauseafeeling sick	441	4.7%
Vomitingbeing sick	370	3.9%
Abortion spontaneousmiscarriage	348	3.7%
Pyrexiafever	342	3.6%
Exposure during pregnancythe medicine was taken during pregnancy	290	3.1%
Premature babya baby born early	289	3.1%
Anaemialow red blood cells	284	3%
Lipodystrophy acquiredchanges in body fat distribution	253	2.7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	250	2.7%
Loss of personal independence in daily activities	230	2.4%
Renal failurekidney failure	218	2.3%
Aspartate aminotransferase increasedraised liver enzyme (AST)	197	2.1%
Alanine aminotransferase increasedraised liver enzyme (ALT)	190	2%
Abdominal painstomach or belly pain	179	1.9%
Deaththe patient died; cause not stated by this term	179	1.9%
Weight decreasedweight loss	177	1.9%
Astheniaweakness or lack of energy	175	1.9%
Pneumonialung infection	170	1.8%
Abortion induced	166	1.8%
Anxiety	166	1.8%
Headachehead pain	166	1.8%
Mitochondrial toxicity	165	1.8%
Stillbirth	164	1.7%
Diplopiadouble vision	161	1.7%
Eyelid ptosis	158	1.7%
Renal failure acute	155	1.6%
Osteonecrosis	146	1.6%
Fatiguetiredness	145	1.5%
Dysphagiadifficulty swallowing	136	1.4%
Dyspnoeashortness of breath	135	1.4%
Psychotic disordera loss of contact with reality	134	1.4%
Malaisegeneral feeling of being unwell	132	1.4%
Acute kidney injurysudden loss of kidney function	127	1.3%
Product use in unapproved indicationused for a purpose not on the label	124	1.3%
Suicidal ideationthoughts of suicide	124	1.3%
Dizzinesslight-headedness or unsteadiness	121	1.3%
General physical health deteriorationgeneral decline in health	121	1.3%
Rashskin rash	120	1.3%
Pancytopenialow counts of all blood cells	116	1.2%
Intentional product use issuedeliberate use not as intended	115	1.2%
Osteoporosisthinning of the bones	114	1.2%
Hypertriglyceridaemia	112	1.2%
Bone density decreased	108	1.1%
Drug ineffectivethe medicine did not work as expected	108	1.1%

Download all 784 terms of Kaletra (CSV)

The counts add to more than 9,419 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Lopinavir and ritonavir with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Lopinavir and ritonavir	Generic name	3,003
Kaletra (this page)	Brand name	9,419

Sum of the separately reported names: 12,422. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Kaletra, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	571	514	125	73	322	26	27	106	57
2005	349	336	59	42	196	10	29	109	13
2006	366	348	54	29	197	19	31	121	18
2007	509	484	94	43	254	21	42	190	25
2008	614	545	113	56	271	19	52	225	69
2009	738	563	69	29	299	26	40	261	175
2010	614	526	59	23	148	19	104	302	88
2011	437	420	70	24	143	9	72	206	17
2012	508	475	69	28	199	15	70	238	33
2013	434	393	56	15	139	16	90	207	41
2014	432	388	42	11	125	5	63	225	44
2015	442	415	35	11	137	15	41	308	27
2016	346	334	33	3	86	5	34	254	12
2017	164	157	13	12	48	11	10	126	7
2018	162	146	11	0	28	4	21	116	16
2019	188	179	20	14	41	9	36	142	9
2020	956	939	141	59	205	2	36	716	17
2021	657	640	152	8	87	2	11	549	17
2022	381	376	72	6	99	7	33	323	5
2023	255	255	45	5	133	6	34	225	0
2024	129	122	34	4	39	4	11	99	7
2025	98	92	30	1	50	1	1	83	6
2026	69	68	26	1	47	4	24	67	1

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Kaletra, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Kaletra, by the year in which FDA received them
Year	Reports
2004	485
2005	371
2006	419
2007	511
2008	630
2009	713
2010	678
2011	478
2012	601
2013	401
2014	463
2015	423
2016	316
2017	145
2018	164
2019	229
2020	1,101
2021	641
2022	317
2023	158
2024	77
2025	56
2026	37

Reports that name Kaletra, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Kaletra
Age	Reports	Share
Under 2	312	3.3%
2 to 11	57	0.6%
12 to 17	59	0.6%
18 to 44	2,279	24.2%
45 to 64	2,157	22.9%
65 to 74	347	3.7%
75 and over	184	2%
Age not given	4,024	42.7%

Sex of the patient in the reports that name Kaletra
Sex	Reports	Share
Female	3,147	33.4%
Male	5,338	56.7%
Unknown or not given	934	9.9%

Type of reporter in the reports that name Kaletra
Reporter	Reports	Share
Physician	3,030	32.2%
Pharmacist	559	5.9%
Other health professional	3,102	32.9%
Lawyer	122	1.3%
Consumer or non-health professional	1,285	13.6%
Not given	1,321	14%

Age and sex are as the report gives them. The reporter is the primary source in the report. 23.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Kaletra record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	5,074	53.9%
Antiretroviral therapy	413	4.4%
Covid-19	330	3.5%
Drug exposure during pregnancy	327	3.5%
Maternal exposure timing unspecified	323	3.4%
Coronavirus infection	280	3%

The reporter fills in the indication, and the field is often empty. Each share is of all 9,419 reports.

Drugs in the same reports

Other drugs that the reports of Kaletra name, in any role, in order of name
Drug	Reports that name the two
Clonazepam	885
Efavirenz	814
Isentress	876
Lamivudine	2,105
Sustiva	1,078
Truvada	1,584
Valproic acid	826
Viread	975
Zidovudine	898
Zopiclone	842

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Lopinavir and ritonavir same ingredient
Genvoya same class
Cobicistat same class
Norvir same class
Prezcobix same class
Kalbitor next in the A to Z list
Kalydeco next in the A to Z list
Kaftrio next in the A to Z list
Kanamycin next in the A to Z list
Kadian next in the A to Z list
Kanjinti next in the A to Z list
Kadcyla next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for KaletraThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Kaletra: adverse event reports that FDA received. https://reportedreactions.com/drug/kaletra/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Kaletra as a suspect or interacting product. The 3,411 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Kaletra was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Kaletra?

No. It is a count of what people reported to FDA: 9,419 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (32.9%), physician (32.2%) and consumer or non-health professional (13.6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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