Altace adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Altace
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 January 2004 to June 2026, FDA received 3,282 adverse event reports that name Altace. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 11,420 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 72 reports in the 12 months to June 2026 and 82 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, 72 (under 0.1%) name Altace. Reports from other health professionals were 32.7% of the reports that name Altace 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 Altace 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 26 reports that name Altace.
In January to March 2026, FDA received 15.
In April to June 2025, FDA received 17.

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 408 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 all 3,282 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 408 terms.

Reaction terms in the reports that name Altace, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,282 reports
Cough	393	12%
Nauseafeeling sick	362	11%
Blood pressure increaseda raised blood pressure reading	318	9.7%
Fatiguetiredness	317	9.7%
Headachehead pain	293	8.9%
Vomitingbeing sick	284	8.7%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	273	8.3%
Astheniaweakness or lack of energy	272	8.3%
Cataractclouding of the eye lens	257	7.8%
Malaisegeneral feeling of being unwell	250	7.6%
Falla fall	248	7.6%
Palpitationsawareness of the heartbeat	240	7.3%
Cerebrovascular accidentstroke	232	7.1%
Hypotensionlow blood pressure	232	7.1%
Renal failure acute	226	6.9%
Sinusitissinus infection	223	6.8%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	217	6.6%
Pyrexiafever	214	6.5%
Arthritis	213	6.5%
Confusional stateconfusion	211	6.4%
Drug ineffectivethe medicine did not work as expected	211	6.4%
Chest discomfort	208	6.3%
Painpain, site not specified	204	6.2%
Angina pectoris	201	6.1%
Hemiplegia	198	6%
Drug interactionan interaction between medicines	197	6%
Dyspnoeashortness of breath	194	5.9%
Gangrenedeath of tissue	190	5.8%
Arterial occlusive disease	187	5.7%
Nasopharyngitisa cold	184	5.6%
Dysphagiadifficulty swallowing	183	5.6%
Cystitis	182	5.5%
Anxiety	180	5.5%
Pneumonialung infection	177	5.4%
Skin exfoliationpeeling skin	174	5.3%
Hyperkalaemiahigh blood potassium	166	5.1%
Muscular weaknessmuscle weakness	165	5%
Psoriasispsoriasis, a skin condition	161	4.9%
Rhinorrhoeaa runny nose	160	4.9%
Sensory loss	160	4.9%
Sinus congestion	160	4.9%
Sinus disorder	160	4.9%
Skin haemorrhage	160	4.9%
Sneezing	160	4.9%
Hemiparesis	158	4.8%
Influenza like illnessflu-like symptoms	158	4.8%
Dysarthria	157	4.8%
Motor dysfunction	157	4.8%
Influenzaflu	155	4.7%
Carotid artery thrombosis	154	4.7%

Download all 408 terms of Altace (CSV)

The counts add to more than 3,282 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 Altace, 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	297	292	17	26	194	21	0	74	5
2005	292	284	26	36	164	24	0	82	8
2006	215	209	13	11	112	9	1	91	6
2007	387	234	13	22	145	16	4	87	153
2008	293	198	20	19	119	15	3	70	95
2009	262	190	13	24	132	9	1	45	72
2010	219	185	13	32	135	14	2	46	34
2011	142	114	11	12	73	2	2	45	28
2012	141	121	8	19	60	7	0	73	20
2013	55	29	3	2	12	1	0	21	26
2014	34	10	1	1	4	0	0	6	24
2015	63	28	4	0	5	1	0	23	35
2016	51	17	1	0	8	0	0	14	34
2017	46	16	0	0	5	0	0	14	30
2018	71	34	2	2	16	0	0	24	37
2019	95	53	3	0	15	1	0	48	42
2020	108	94	12	3	34	6	0	80	14
2021	88	84	11	2	19	0	0	79	4
2022	109	95	5	16	40	14	0	88	14
2023	54	49	0	6	6	3	0	48	5
2024	78	75	18	48	50	11	0	64	3
2025	107	106	11	85	87	48	0	104	1
2026	75	70	5	47	52	38	1	70	5

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 Altace, 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 Altace, by the year in which FDA received them
Year	Reports
2004	273
2005	278
2006	231
2007	245
2008	364
2009	187
2010	349
2011	155
2012	175
2013	53
2014	48
2015	69
2016	65
2017	50
2018	82
2019	114
2020	132
2021	99
2022	89
2023	38
2024	71
2025	74
2026	41

Reports that name Altace, 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 Altace
Age	Reports	Share
Under 2	3	0.1%
2 to 11	2	0.1%
12 to 17	2	0.1%
18 to 44	94	2.9%
45 to 64	686	20.9%
65 to 74	739	22.5%
75 and over	594	18.1%
Age not given	1,162	35.4%

Sex of the patient in the reports that name Altace
Sex	Reports	Share
Female	1,523	46.4%
Male	1,090	33.2%
Unknown or not given	669	20.4%

Type of reporter in the reports that name Altace
Reporter	Reports	Share
Physician	569	17.3%
Pharmacist	145	4.4%
Other health professional	1,072	32.7%
Lawyer	3	0.1%
Consumer or non-health professional	1,338	40.8%
Not given	155	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 36.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Altace record
Indication as recorded (MedDRA)	Reports	Share
Hypertension	934	28.5%
Essential hypertension	70	2.1%
Cardiac failure	61	1.9%
Cardiac failure congestive	61	1.9%
Prophylaxis	28	0.9%
Blood pressure increased	21	0.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,282 reports.

Drugs in the same reports

Other drugs that the reports of Altace name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	352
Aspirin	592
Gliclazide	247
Hydrochlorothiazide	390
Lantus	247
Metformin	231
Methotrexate	240
Prednisone	394
Ramipril	254
Rituximab	258

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

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These links are for navigation. No count selected them.

Official pages

DailyMed labels for AltaceThe 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. Altace: adverse event reports that FDA received. https://reportedreactions.com/drug/altace/ 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 Altace as a suspect or interacting product. The 11,420 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 Altace 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 Altace?

No. It is a count of what people reported to FDA: 3,282 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?

Consumer or non-health professional (40.8%), other health professional (32.7%) and physician (17.3%). 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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