Atazanavir adverse event reports that FDA received

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

Name type: Generic name
Class: Protease inhibitor
Also reported as: Atazanavir /01555902/

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.

Reports on file

From January 2004 to June 2026, FDA received 2,725 adverse event reports that name Atazanavir. In these reports the drug is a suspect or interacting product.

In the same period, 1,309 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 28 reports in the 12 months to June 2026 and 63 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Atazanavir 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 14 reports that name Atazanavir.
In January to March 2026, FDA received 0.
In April to June 2025, FDA received 14.

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 284 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 2,723 of the 2,725 reports (99.9%).

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 284 terms.

Reaction terms in the reports that name Atazanavir, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,725 reports
Drug interactionan interaction between medicines	483	17.7%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	281	10.3%
Depressionlow mood	241	8.8%
Virologic failure	158	5.8%
Exposure during pregnancythe medicine was taken during pregnancy	137	5%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	106	3.9%
Premature babya baby born early	83	3%
Drug resistance	80	2.9%
Nauseafeeling sick	80	2.9%
Hyperbilirubinaemia	75	2.8%
Loss of personal independence in daily activities	73	2.7%
Treatment noncompliancethe treatment was not taken as directed	72	2.6%
Pathogen resistance	65	2.4%
Diarrhoealoose or frequent stools	60	2.2%
Off label useused for a purpose or in a way not on the label	59	2.2%
Headachehead pain	56	2.1%
Suicidal ideationthoughts of suicide	56	2.1%
Jaundiceyellowing of the skin or eyes	54	2%
Viral mutation identified	54	2%
Anxiety	53	1.9%
Vomitingbeing sick	53	1.9%
Premature delivery	52	1.9%
Product use in unapproved indicationused for a purpose not on the label	52	1.9%
Psychotic disordera loss of contact with reality	51	1.9%
Blood bilirubin increased	50	1.8%
Drug ineffectivethe medicine did not work as expected	49	1.8%
Nephrolithiasiskidney stones	49	1.8%
Immune reconstitution inflammatory syndrome	48	1.8%
Toxicity to various agentspoisoning or toxic effect of one or more substances	48	1.8%
Alanine aminotransferase increasedraised liver enzyme (ALT)	47	1.7%
Depression suicidal	46	1.7%
Depressive symptom	46	1.7%
No adverse eventno adverse event was reported	46	1.7%
Paranoia	46	1.7%
Psychiatric decompensation	46	1.7%
Psychomotor skills impaired	46	1.7%
Tearfulness	46	1.7%
Treatment failurethe treatment did not work	45	1.7%
Abdominal painstomach or belly pain	44	1.6%
Abortion spontaneousmiscarriage	44	1.6%
Low birth weight baby	44	1.6%
Weight decreasedweight loss	43	1.6%
Pyrexiafever	40	1.5%
Anaemialow red blood cells	38	1.4%
Aspartate aminotransferase increasedraised liver enzyme (AST)	37	1.4%
Deaththe patient died; cause not stated by this term	37	1.4%
Myocardial infarctionheart attack	37	1.4%
Rashskin rash	36	1.3%
Acute kidney injurysudden loss of kidney function	34	1.2%
Electrocardiogram QT prolongeda QT prolongation on the ECG	34	1.2%

Download all 284 terms of Atazanavir (CSV)

The counts add to more than 2,725 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 Atazanavir with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Atazanavir (this page)	Generic name	2,725
Atazanavir sulfate	Generic name	2,621
Reyataz	Brand name	5,181

Sum of the separately reported names: 10,527. 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 Atazanavir, 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	104	85	10	7	50	3	2	42	19
2005	90	85	10	10	50	1	1	31	5
2006	79	77	11	8	28	0	4	44	2
2007	29	23	3	2	9	0	1	14	6
2008	52	50	4	0	19	5	2	35	2
2009	62	57	10	7	22	2	1	35	5
2010	86	85	10	13	32	3	3	57	1
2011	127	122	14	12	44	0	1	79	5
2012	112	111	8	5	48	2	1	74	1
2013	117	115	8	12	50	5	6	76	2
2014	110	108	11	11	42	1	2	83	2
2015	167	158	35	3	29	3	14	127	9
2016	186	184	12	3	24	0	7	165	2
2017	205	204	10	4	27	0	8	179	1
2018	143	113	1	0	22	1	11	97	30
2019	133	127	4	0	31	1	17	115	6
2020	182	167	8	4	33	0	35	145	15
2021	226	199	14	3	32	0	14	183	27
2022	201	189	18	6	34	1	17	166	12
2023	112	107	12	1	27	0	16	98	5
2024	74	70	14	0	20	0	7	52	4
2025	102	100	20	0	36	0	1	97	2
2026	26	26	2	1	6	2	0	25	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 Atazanavir, 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 Atazanavir, by the year in which FDA received them
Year	Reports
2004	77
2005	100
2006	99
2007	28
2008	53
2009	60
2010	98
2011	131
2012	124
2013	107
2014	107
2015	176
2016	189
2017	217
2018	148
2019	162
2020	189
2021	253
2022	191
2023	102
2024	50
2025	50
2026	14

Reports that name Atazanavir, 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 Atazanavir
Age	Reports	Share
Under 2	51	1.9%
2 to 11	16	0.6%
12 to 17	21	0.8%
18 to 44	675	24.8%
45 to 64	741	27.2%
65 to 74	55	2%
75 and over	18	0.7%
Age not given	1,148	42.1%

Sex of the patient in the reports that name Atazanavir
Sex	Reports	Share
Female	670	24.6%
Male	1,286	47.2%
Unknown or not given	769	28.2%

Type of reporter in the reports that name Atazanavir
Reporter	Reports	Share
Physician	598	21.9%
Pharmacist	81	3%
Other health professional	1,596	58.6%
Lawyer	0	0%
Consumer or non-health professional	322	11.8%
Not given	128	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 28.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Atazanavir record
Indication as recorded (MedDRA)	Reports	Share
Hiv infection	1,713	62.9%
Antiretroviral therapy	166	6.1%
Maternal exposure timing unspecified	48	1.8%
Prophylaxis against HIV infection	27	1%
Covid-19	24	0.9%
Acquired immunodeficiency syndrome	20	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,725 reports.

Drugs in the same reports

Other drugs that the reports of Atazanavir name, in any role, in order of name
Drug	Reports that name the two
Abacavir	382
Efavirenz	302
Emtricitabine	408
Kaletra	294
Lamivudine	966
Raltegravir	301
Ritonavir	1,731
Tenofovir	386
Tenofovir disoproxil fumarate	290
Zidovudine	381

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

Atazanavir sulfate same ingredient
Reyataz same ingredient
Darunavir same class
Nelfinavir mesylate same class
Atarax next in the A to Z list
Atazanavir Ritonavir next in the A to Z list
Atacand Hct next in the A to Z list
Atacand next in the A to Z list
Atelvia next in the A to Z list
Asunaprevir next in the A to Z list
Atenolol next in the A to Z list
Astrazeneca Covid-19 Vaccine 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 AtazanavirThe 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. Atazanavir: adverse event reports that FDA received. https://reportedreactions.com/drug/atazanavir/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Atazanavir as a suspect or interacting product. The 1,309 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 Atazanavir 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 Atazanavir?

No. It is a count of what people reported to FDA: 2,725 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 (58.6%), physician (21.9%) and consumer or non-health professional (11.8%). 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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