Lopinavir adverse event reports that FDA received

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

Name type: Generic name

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 February 2004 to May 2026, FDA received 1,626 adverse event reports that name Lopinavir. In these reports the drug is a suspect or interacting product.

In the same period, 489 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 19 reports in the 12 months to June 2026 and 22 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, 19 (under 0.1%) name Lopinavir. Reports from other health professionals were 71.7% of the reports that name Lopinavir 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 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 15 reports that name Lopinavir.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 10.

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 178 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 1,619 of the 1,626 reports (99.6%).

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 178 terms.

Reaction terms in the reports that name Lopinavir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,626 reports
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	246	15.1%
Exposure during pregnancythe medicine was taken during pregnancy	191	11.7%
Virologic failure	173	10.6%
Off label useused for a purpose or in a way not on the label	157	9.7%
Lipodystrophy acquiredchanges in body fat distribution	149	9.2%
Drug resistance	148	9.1%
Premature babya baby born early	106	6.5%
Diplopiadouble vision	100	6.2%
Eyelid ptosis	100	6.2%
Drug interactionan interaction between medicines	96	5.9%
Treatment failurethe treatment did not work	96	5.9%
Mitochondrial toxicity	92	5.7%
Premature delivery	86	5.3%
Progressive external ophthalmoplegia	85	5.2%
Viral mutation identified	75	4.6%
Aspartate aminotransferase increasedraised liver enzyme (AST)	64	3.9%
Intentional product use issuedeliberate use not as intended	63	3.9%
Alanine aminotransferase increasedraised liver enzyme (ALT)	59	3.6%
Pathogen resistance	53	3.3%
Portal hypertension	52	3.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	51	3.1%
Treatment noncompliancethe treatment was not taken as directed	51	3.1%
Abortion spontaneousmiscarriage	47	2.9%
Ultrasound antenatal screen	47	2.9%
Hepatic cytolysis	45	2.8%
Diarrhoealoose or frequent stools	40	2.5%
Deaththe patient died; cause not stated by this term	38	2.3%
Hydrops foetalis	34	2.1%
Drug abusemisuse of a medicine	33	2%
Cleft lip and palate	32	2%
Trisomy 18	32	2%
Product use in unapproved indicationused for a purpose not on the label	30	1.8%
Vomitingbeing sick	29	1.8%
Nauseafeeling sick	28	1.7%
Ophthalmoplegia	28	1.7%
Immune reconstitution syndrome	27	1.7%
Viral load increased	27	1.7%
Caesarean section	26	1.6%
Depressionlow mood	26	1.6%
Product use issuea problem in how the product was used	26	1.6%
Low birth weight baby	23	1.4%
Immune reconstitution inflammatory syndrome	22	1.4%
Stillbirth	21	1.3%
Anaemialow red blood cells	20	1.2%
Hypokalaemialow blood potassium	19	1.2%
Acute kidney injurysudden loss of kidney function	18	1.1%
Drug ineffectivethe medicine did not work as expected	18	1.1%
Pyrexiafever	18	1.1%
Somnolencedrowsiness	17	1%
Fatiguetiredness	16	1%

Download all 178 terms of Lopinavir (CSV)

The counts add to more than 1,626 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, 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	15	14	4	1	3	1	0	13	1
2005	24	24	5	0	9	2	0	12	0
2006	7	7	1	0	4	0	0	2	0
2007	41	40	7	0	12	0	1	31	1
2008	22	22	2	0	3	0	2	18	0
2009	86	86	3	2	19	0	4	67	0
2010	43	43	5	0	17	0	1	32	0
2011	31	31	1	0	5	0	5	30	0
2012	17	17	9	0	3	0	0	11	0
2013	33	32	6	1	11	1	1	20	1
2014	22	22	3	0	8	0	1	17	0
2015	73	72	13	0	5	0	7	64	1
2016	284	282	54	2	15	8	11	235	2
2017	258	258	20	1	12	0	6	233	0
2018	99	96	2	0	11	3	1	92	3
2019	44	39	3	0	6	1	4	38	5
2020	173	147	11	11	30	3	16	117	26
2021	99	92	3	7	24	1	8	83	7
2022	68	67	11	1	18	1	12	62	1
2023	80	80	22	1	31	2	19	77	0
2024	37	37	6	0	15	0	8	33	0
2025	39	39	6	0	14	1	1	39	0
2026	31	31	22	1	24	0	22	31	0

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, 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, by the year in which FDA received them
Year	Reports
2004	11
2005	22
2006	15
2007	43
2008	22
2009	79
2010	60
2011	32
2012	21
2013	33
2014	20
2015	70
2016	297
2017	262
2018	118
2019	64
2020	167
2021	100
2022	79
2023	61
2024	14
2025	21
2026	15

Reports that name Lopinavir, 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
Age	Reports	Share
Under 2	55	3.4%
2 to 11	33	2%
12 to 17	25	1.5%
18 to 44	260	16%
45 to 64	308	18.9%
65 to 74	45	2.8%
75 and over	24	1.5%
Age not given	876	53.9%

Sex of the patient in the reports that name Lopinavir
Sex	Reports	Share
Female	281	17.3%
Male	592	36.4%
Unknown or not given	753	46.3%

Type of reporter in the reports that name Lopinavir
Reporter	Reports	Share
Physician	229	14.1%
Pharmacist	12	0.7%
Other health professional	1,166	71.7%
Lawyer	0	0%
Consumer or non-health professional	78	4.8%
Not given	141	8.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 27.9% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Lopinavir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	905	55.7%
Covid-19	116	7.1%
Antiretroviral therapy	74	4.6%
Prophylaxis against HIV infection	66	4.1%
Antiviral treatment	27	1.7%
Foetal exposure during pregnancy	13	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,626 reports.

Drugs in the same reports

Other drugs that the reports of Lopinavir name, in any role, in order of name
Drug	Reports that name the two
Abacavir	311
Didanosine	362
Efavirenz	466
Emtricitabine	379
Lamivudine	945
Nevirapine	501
Ritonavir	1,340
Stavudine	370
Tenofovir	414
Zidovudine	748

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

Lopid next in the A to Z list
Lopinavir + Ritonavir next in the A to Z list
Loperamide hydrochloride next in the A to Z list
Lopinavir and ritonavir next in the A to Z list
Loperamide hcl next in the A to Z list
Lopinavir Ritonavir next in the A to Z list
Loperamide next in the A to Z list
Lopinavir+ritonavir next in the A to Z list
Lonsurf next in the A to Z list
Lopressor next in the A to Z list
Lonquex next in the A to Z list
Loratadine next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for LopinavirThe 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: adverse event reports that FDA received. https://reportedreactions.com/drug/lopinavir/ 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 as a suspect or interacting product. The 489 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 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?

No. It is a count of what people reported to FDA: 1,626 reports from February 2004 to May 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 (71.7%), physician (14.1%) and consumer or non-health professional (4.8%). 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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