Lopinavir Ritonavir adverse event reports that FDA received

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

Name type: Product name as reported

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 June 2004 to June 2026, FDA received 2,307 adverse event reports that name Lopinavir Ritonavir. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 396 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 80 reports in the 12 months to June 2026 and 234 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, 80 (under 0.1%) name Lopinavir Ritonavir. Reports from other health professionals were 60.2% of the reports that name Lopinavir Ritonavir and 19.7% 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 Lopinavir Ritonavir 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 32 reports that name Lopinavir Ritonavir.
In January to March 2026, FDA received 14.
In April to June 2025, FDA received 163.

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 279 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 2,273 of the 2,307 reports (98.5%).

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 279 terms.

Reaction terms in the reports that name Lopinavir Ritonavir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,307 reports
Off label useused for a purpose or in a way not on the label	625	27.1%
Drug interactionan interaction between medicines	377	16.3%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	321	13.9%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	170	7.4%
Product use in unapproved indicationused for a purpose not on the label	165	7.2%
Neurodevelopmental disorder	157	6.8%
Virologic failure	135	5.9%
Depressionlow mood	133	5.8%
Pathogen resistance	129	5.6%
Intentional product use issuedeliberate use not as intended	106	4.6%
Exposure during pregnancythe medicine was taken during pregnancy	97	4.2%
Diarrhoealoose or frequent stools	96	4.2%
Viral mutation identified	90	3.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	81	3.5%
Drug resistance	81	3.5%
Abortion spontaneousmiscarriage	80	3.5%
Aspartate aminotransferase increasedraised liver enzyme (AST)	78	3.4%
Drug ineffectivethe medicine did not work as expected	78	3.4%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	77	3.3%
Hepatic cytolysis	73	3.2%
Electrocardiogram QT prolongeda QT prolongation on the ECG	71	3.1%
Dyslipidaemia	69	3%
Loss of personal independence in daily activities	69	3%
Treatment noncompliancethe treatment was not taken as directed	69	3%
Acute kidney injurysudden loss of kidney function	67	2.9%
Condition aggravatedthe condition being treated got worse	66	2.9%
Covid-19COVID-19 infection	62	2.7%
Vomitingbeing sick	62	2.7%
Drug level increaseda raised blood level of the medicine	58	2.5%
Drug ineffective for unapproved indication	55	2.4%
Nauseafeeling sick	55	2.4%
Anaemialow red blood cells	53	2.3%
Treatment failurethe treatment did not work	53	2.3%
Pneumonialung infection	52	2.3%
Drug-induced liver injury	49	2.1%
Ultrasound antenatal screen	48	2.1%
Pyrexiafever	43	1.9%
Product use issuea problem in how the product was used	42	1.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	41	1.8%
Premature babya baby born early	40	1.7%
Anxiety	38	1.6%
Incorrect route of product administrationthe product was given by the wrong route	37	1.6%
No adverse eventno adverse event was reported	37	1.6%
Drug abusemisuse of a medicine	36	1.6%
Hydrops foetalis	36	1.6%
Cough	35	1.5%
Psychiatric decompensation	35	1.5%
Suicidal ideationthoughts of suicide	35	1.5%
Trisomy 18	35	1.5%
Cleft lip and palate	34	1.5%

Download all 279 terms of Lopinavir Ritonavir (CSV)

The counts add to more than 2,307 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.

Outcomes by year

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

Outcomes in the reports that name Lopinavir Ritonavir, 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
2012	12	11	2	0	4	0	2	5	1
2013	22	21	7	2	10	0	0	9	1
2014	7	5	0	1	0	0	1	4	2
2015	7	6	1	0	1	0	0	5	1
2016	15	15	0	0	1	0	2	13	0
2017	9	8	2	1	1	1	0	7	1
2018	73	9	0	0	0	0	0	9	64
2019	11	11	4	1	4	0	1	10	0
2020	190	125	39	19	39	1	1	84	65
2021	242	213	20	17	112	2	4	183	29
2022	583	556	90	30	265	4	59	426	27
2023	539	533	85	39	200	7	43	474	6
2024	168	166	30	14	66	2	18	137	2
2025	309	308	30	13	96	0	143	172	1
2026	120	119	31	2	42	2	70	76	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 Lopinavir Ritonavir, 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 Lopinavir Ritonavir, by the year in which FDA received them
Year	Reports
2004	1
2006	1
2008	2
2009	3
2010	1
2011	2
2012	15
2013	32
2014	16
2015	8
2016	22
2017	11
2018	125
2019	69
2020	306
2021	366
2022	548
2023	382
2024	115
2025	236
2026	46

Reports that name Lopinavir Ritonavir, 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 Lopinavir Ritonavir
Age	Reports	Share
Under 2	84	3.6%
2 to 11	45	2%
12 to 17	26	1.1%
18 to 44	503	21.8%
45 to 64	516	22.4%
65 to 74	216	9.4%
75 and over	111	4.8%
Age not given	806	34.9%

Sex of the patient in the reports that name Lopinavir Ritonavir
Sex	Reports	Share
Female	640	27.7%
Male	1,011	43.8%
Unknown or not given	656	28.4%

Type of reporter in the reports that name Lopinavir Ritonavir
Reporter	Reports	Share
Physician	610	26.4%
Pharmacist	40	1.7%
Other health professional	1,388	60.2%
Lawyer	1	under 0.1%
Consumer or non-health professional	159	6.9%
Not given	109	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 13.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lopinavir Ritonavir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	783	33.9%
Covid-19	536	23.2%
Covid-19 pneumonia	196	8.5%
Antiretroviral therapy	62	2.7%
Maternal exposure timing unspecified	50	2.2%
Antiviral treatment	32	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,307 reports.

Drugs in the same reports

Other drugs that the reports of Lopinavir Ritonavir name, in any role, in order of name
Drug	Reports that name the two
Azithromycin	240
Efavirenz	383
Hydroxychloroquine	497
Isentress	289
Kaletra	238
Lamivudine	727
Nevirapine	210
Ritonavir	265
Tenofovir disoproxil fumarate	223
Zidovudine	446

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 next in the A to Z list
Lopinavir+ritonavir next in the A to Z list
Lopinavir + Ritonavir next in the A to Z list
Lopressor next in the A to Z list
Lopinavir next in the A to Z list
Loratadine next in the A to Z list
Lopid next in the A to Z list
Loratadine and pseudoephedrine sulfate next in the A to Z list
Loperamide hydrochloride next in the A to Z list
Loratadine Syrup 5mg/5ml next in the A to Z list
Loperamide hcl next in the A to Z list
Lorazepam next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for Lopinavir RitonavirThe 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. Lopinavir Ritonavir: adverse event reports that FDA received. https://reportedreactions.com/drug/lopinavir-ritonavir/ 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 Lopinavir Ritonavir as a suspect or interacting product. The 396 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 Lopinavir Ritonavir 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 Lopinavir Ritonavir?

No. It is a count of what people reported to FDA: 2,307 reports from June 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 (60.2%), physician (26.4%) and consumer or non-health professional (6.9%). 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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