Pharmacologic class (EPC) · 24 drug pages

Angiotensin 2 receptor blocker: adverse event reports filed with FDA

243,200 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

243,200
reports across the class: 1.2% of all reports; 10,424
reports, 12 months to June 2026: 10,847 in the 12 months before; 67.6%
marked serious by the reporter: 57.4% across all reports; 24
drugs with a page: brand and generic names counted separately

Angiotensin 2 receptor blocker is a pharmacologic class (an FDA Established Pharmacologic Class) with 24 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 243,200 adverse event reports received by FDA, 1.2% of the database, from January 2004 to June 2026.

10,424 reports arrived in the 12 months to June 2026, close to the 10,847 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 67.6% of the class's reports are marked serious, 11.1% record death among the outcomes and 28.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are dizziness (7.8%), hypotension (7.7%) and fatigue (6.7%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
EntrestoSacubitril and valsartan	brand	105,173	1,285	49.3%	Hypotension
DiovanValsartan	brand	17,179	133	91.7%	Blood pressure increased
Valsartan	generic	16,935	923	83.8%	Drug ineffective
Losartan	generic	15,176	1,137	80.1%	Dizziness
Candesartan	generic	10,197	1,487	98.6%	Off label use
Irbesartan	generic	10,055	692	93.7%	Acute kidney injury
BenicarOlmesartan medoxomil	brand	8,370	79	69.4%	Sprue-like enteropathy
Losartan potassium	generic	6,725	246	73%	Drug ineffective
ExforgeAmlodipine besylate and valsartan	brand	6,266	108	95.3%	Blood pressure increased
Diovan HCTValsartan and hydrochlorothiazide	brand	5,670	30	95.3%	Blood pressure increased
FilspariSparsentan	brand	5,598	2,908	16.1%	Dizziness
Candesartan cilexetil	generic	5,311	622	97.6%	Dyspnoea
CozaarLosartan potassium	brand	4,913	60	70.2%	Drug ineffective
Olmesartan medoxomil	generic	4,777	169	90.6%	Weight decreased
Telmisartan	generic	4,666	357	91.2%	Dyspnoea
AtacandCandesartan cilexetil	brand	4,597	48	76.6%	Blood pressure increased
Exforge HCTAmlodipine valsartan and hydrochlorothiazide	brand	2,891	53	95.8%	Blood pressure increased
AvaproIrbesartan	brand	2,516	23	36.6%	Drug ineffective
Valsartan and hydrochlorothiazide	generic	1,513	17	76.1%	Dizziness
AvalideIrbesartan and hydrochlorothiazide	brand	1,236	2	24.8%	Drug ineffective
AzorAmlodipine besylate and olmesartan medoxomil	brand	1,044	9	64.9%	Sprue-like enteropathy
Micardis HCTTelmisartan and hydrochlorothiazide	brand	984	7	53.8%	Dizziness
EdarbiAzilsartan kamedoxomil	brand	867	25	40.1%	Drug ineffective
Irbesartan and hydrochlorothiazide	generic	541	4	82.6%	Hyponatraemia

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Dizzinesslight-headedness or unsteadiness7.8%18,914
Hypotensionlow blood pressure7.7%18,720
Fatiguetiredness6.7%16,199
Dyspnoeashortness of breath6.6%16,091
Coughcough5.3%12,768
Drug ineffectivethe medicine did not work as expected5%12,259
Deaththe patient died; cause not stated by this term4.8%11,560
Malaisegeneral feeling of being unwell4.7%11,545
Hypertensionhigh blood pressure4.2%10,145
Headachehead pain4.1%9,965
Weight decreasedweight loss4%9,739
Blood pressure increaseda raised blood pressure reading4%9,614
Astheniaweakness or lack of energy3.6%8,770
Acute kidney injurysudden loss of kidney function3.6%8,768
Diarrhoealoose or frequent stools3.6%8,760
Wrong technique in product usage processthe product was used in the wrong way3.6%8,725
Nauseafeeling sick3.5%8,576
Falla fall3.5%8,537
Painpain, site not specified2.9%6,983
Off label useused for a purpose or in a way not on the label2.7%6,450
Vomitingbeing sick2.6%6,310
Arthralgiajoint pain2.4%5,946
Feeling abnormalfeeling odd or not right2.4%5,892
Weight increasedweight gain2.4%5,781
Cardiac failureheart failure2.3%5,707

Solid bar: share of all class reports. Hollow bar: the median share across the 24 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death11.1%26,928

Life-threatening5%12,186

Hospitalisation (initial or prolonged)28.7%69,918

Disability3%7,304

Congenital anomaly1.3%3,142

Other serious42.8%104,206

Not serious32.4%78,871

Patient age

Under 20.1%349

2 to 110.1%192

12 to 170.2%405

18 to 443.9%9,421

45 to 6414.6%35,594

65 to 7412.4%30,055

75 and over14.6%35,557

Age not given54.1%131,627

Who reported

Physician21.8%53,101

Pharmacist4.8%11,773

Other health professional15.7%38,297

Lawyer0.8%1,977

Consumer or non-health professional54.2%131,810

Not given2.6%6,242

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Angiotensin 2 receptor blocker reports

Which drugs are in the Angiotensin 2 receptor blocker class on this site?

Entresto, Diovan, Valsartan, Losartan, Candesartan and Irbesartan and 18 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

243,200 reports through June 2026, 10,424 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

dizziness (7.8%), hypotension (7.7%), fatigue (6.7%), dyspnoea (6.6%) and cough (5.3%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.