Saquinavir adverse event reports that FDA received

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

Name type: Generic name
Also reported as: Cap Saquinavir

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 May 2026, FDA received 1,162 adverse event reports that name Saquinavir. In these reports the drug is a suspect or interacting product.

In the same period, 287 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 10 reports in the 12 months to June 2026 and 23 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, 10 (under 0.1%) name Saquinavir. Reports from consumers or other non-health professionals were 7.9% of the reports that name Saquinavir 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 Saquinavir 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 1 report that names Saquinavir.
In January to March 2026, FDA received 6.
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 159 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 1,160 of the 1,162 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 159 terms.

Reaction terms in the reports that name Saquinavir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,162 reports
Lipodystrophy acquiredchanges in body fat distribution	223	19.2%
Eyelid ptosis	190	16.4%
Mitochondrial toxicity	190	16.4%
Diplopiadouble vision	182	15.7%
Dysphagiadifficulty swallowing	104	9%
Drug resistance	102	8.8%
Viral mutation identified	92	7.9%
Progressive external ophthalmoplegia	91	7.8%
Pathogen resistance	72	6.2%
Drug interactionan interaction between medicines	67	5.8%
Ophthalmoplegia	65	5.6%
Blood lactic acid increased	56	4.8%
Treatment failurethe treatment did not work	56	4.8%
Virologic failure	55	4.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	45	3.9%
Nauseafeeling sick	43	3.7%
Diarrhoealoose or frequent stools	39	3.4%
Drug ineffectivethe medicine did not work as expected	38	3.3%
Anaemialow red blood cells	37	3.2%
Drug exposure during pregnancythe medicine was taken during pregnancy	37	3.2%
Pyrexiafever	34	2.9%
Portal hypertension	33	2.8%
Vomitingbeing sick	33	2.8%
Fatiguetiredness	31	2.7%
Osteonecrosis	27	2.3%
Lactic acidosisa build-up of lactic acid in the blood	24	2.1%
Hepatotoxicityliver injury	23	2%
Weight decreasedweight loss	23	2%
Astheniaweakness or lack of energy	22	1.9%
Blood triglycerides increased	22	1.9%
Hypertensionhigh blood pressure	20	1.7%
Pneumonialung infection	18	1.5%
Renal impairmentreduced kidney function	18	1.5%
Drug intolerancethe medicine was not tolerated	17	1.5%
General physical health deteriorationgeneral decline in health	17	1.5%
Immune reconstitution syndrome	17	1.5%
Myocardial infarctionheart attack	17	1.5%
Osteoporosisthinning of the bones	17	1.5%
Dyspnoeashortness of breath	16	1.4%
Premature babya baby born early	16	1.4%
Blood HIV RNA increased	15	1.3%
Deep vein thrombosisa blood clot in a deep vein	15	1.3%
Hepatic steatosisfatty liver	15	1.3%
Hepatomegaly	15	1.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	15	1.3%
Multiple-drug resistance	15	1.3%
Rashskin rash	15	1.3%
Abdominal painstomach or belly pain	14	1.2%
Extraocular muscle paresis	14	1.2%
Hepatic cirrhosis	13	1.1%

Download all 159 terms of Saquinavir (CSV)

The counts add to more than 1,162 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 Saquinavir, 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	66	63	16	4	35	4	2	13	3
2005	56	54	7	3	13	0	1	39	2
2006	43	42	5	2	16	1	2	27	1
2007	72	71	2	1	19	2	13	47	1
2008	38	36	1	0	16	0	5	19	2
2009	94	94	11	4	25	0	9	63	0
2010	57	57	5	1	18	1	3	41	0
2011	54	53	3	2	13	0	2	40	1
2012	33	33	0	0	13	2	0	25	0
2013	36	35	7	2	11	3	3	21	1
2014	65	65	6	0	9	0	19	40	0
2015	44	39	5	2	5	0	8	35	5
2016	36	36	8	0	6	0	4	31	0
2017	43	42	5	2	6	1	2	41	1
2018	54	54	1	2	4	0	1	53	0
2019	50	46	0	1	1	0	5	45	4
2020	109	109	0	0	3	0	9	106	0
2021	54	51	7	1	6	0	3	46	3
2022	46	45	0	2	0	0	1	45	1
2023	44	44	0	0	7	0	1	42	0
2024	23	23	1	0	7	0	1	23	0
2025	29	29	1	0	3	0	1	29	0
2026	16	16	3	0	6	1	0	15	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 Saquinavir, 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 Saquinavir, by the year in which FDA received them
Year	Reports
2004	56
2005	60
2006	49
2007	69
2008	36
2009	99
2010	69
2011	55
2012	34
2013	37
2014	68
2015	48
2016	33
2017	47
2018	67
2019	71
2020	106
2021	45
2022	31
2023	45
2024	11
2025	19
2026	7

Reports that name Saquinavir, 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 Saquinavir
Age	Reports	Share
Under 2	16	1.4%
2 to 11	15	1.3%
12 to 17	24	2.1%
18 to 44	264	22.7%
45 to 64	406	34.9%
65 to 74	13	1.1%
75 and over	1	0.1%
Age not given	423	36.4%

Sex of the patient in the reports that name Saquinavir
Sex	Reports	Share
Female	247	21.3%
Male	666	57.3%
Unknown or not given	249	21.4%

Type of reporter in the reports that name Saquinavir
Reporter	Reports	Share
Physician	311	26.8%
Pharmacist	4	0.3%
Other health professional	581	50%
Lawyer	0	0%
Consumer or non-health professional	92	7.9%
Not given	174	15%

Age and sex are as the report gives them. The reporter is the primary source in the report. 18.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Saquinavir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	741	63.8%
Antiretroviral therapy	74	6.4%
Drug exposure during pregnancy	13	1.1%
Acquired immunodeficiency syndrome	11	0.9%
Hiv test positive	9	0.8%
Retroviral infection	5	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,162 reports.

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for SaquinavirThe 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. Saquinavir: adverse event reports that FDA received. https://reportedreactions.com/drug/saquinavir/ 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 Saquinavir as a suspect or interacting product. The 287 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 Saquinavir 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 Saquinavir?

No. It is a count of what people reported to FDA: 1,162 reports from January 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 (50%), physician (26.8%) and consumer or non-health professional (7.9%). 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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