Drugs › Angiotensin 2 receptor blocker
Generic name
Candesartan: adverse event reports filed with FDA
10,197 reports list it as a suspect or interacting product, 2004–2026. Class: Angiotensin 2 receptor blocker. Also reported as Candesartan /01349502/, Candesartan Tablets, Candesartan Tablet.
- 10,197
- reports as suspect product
- 0.1% of all reports · about 453 a year
- 1,487
- reports, 12 months to June 2026
- 1,909 in the 12 months before
- 98.6%
- marked serious by the reporter
- 67.6% across the class
- 25.5%
- record death among outcomes, as reported
- 2,599 reports · not verified by FDA
Between January 2004 and June 2026, 10,197 adverse event reports received by FDA list candesartan, a generic name as a suspect or interacting product. Reports that mention it only as a concomitant medication (25,689) are left out of every figure here.
In the 12 months to June 2026, 1,487 reports listed it, down 22% from 1,909 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 453 reports a year and 0.1% of the 20,646,523 reports in the database, and 4.2% of the reports for the angiotensin 2 receptor blocker class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded off label use (21.5%), fatigue (16.8%) and pain (16.7%). A report can list several reactions, so shares add to more than 100%; 1,583 different terms appear across these reports. Off label use is recorded in 21.5% of these reports, a larger share than in the median angiotensin 2 receptor blocker drug (1.8%).
98.6% of the reports are marked serious by the reporter (67.6% across the class); 25.5% record death among the outcomes and 57.7% record hospitalisation, as reported. 45.8% of the reports came from other health professionals, and the largest patient age group is 75 and over (22.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Candesartan reports recording the termmedian drug in angiotensin 2 receptor blocker
- Off label useused for a purpose or in a way not on the label21.5%2,197
- Fatiguetiredness16.8%1,712
- Painpain, site not specified16.7%1,700
- Dyspnoeashortness of breath16.2%1,657
- Drug ineffectivethe medicine did not work as expected16.2%1,650
- Headachehead pain15.5%1,579
- Dizzinesslight-headedness or unsteadiness14.7%1,502
- Nauseafeeling sick14.3%1,461
- Vomitingbeing sick14.3%1,460
- Diarrhoealoose or frequent stools13.6%1,382
- Condition aggravatedthe condition being treated got worse13.2%1,350
- Arthralgiajoint pain12.9%1,320
- Abdominal discomfortstomach discomfort12.8%1,307
- Intentional product use issuedeliberate use not as intended12.8%1,303
- Migrainemigraine12.5%1,277
- Confusional stateconfusion12.5%1,274
- Malaisegeneral feeling of being unwell12.1%1,237
- Astheniaweakness or lack of energy12%1,221
- General physical health deteriorationgeneral decline in health11.8%1,201
- Hypertensionhigh blood pressure11.7%1,196
- Pericarditisinflammation of the sac around the heart11.6%1,183
- Product use in unapproved indicationused for a purpose not on the label11.6%1,181
- Abdominal pain upperupper stomach pain11.6%1,178
- Wheezingwheezing11.5%1,176
- Rashskin rash11.5%1,174
- Peripheral swellingswelling of the arms or legs11%1,117
- Gastrooesophageal reflux diseaseacid reflux10.9%1,114
- Maternal exposure during pregnancythe mother took the medicine during pregnancy10.9%1,110
- Alopeciahair loss10.7%1,087
- Systemic lupus erythematosuslupus, an autoimmune disease10.6%1,080
Top 30 of 1,583 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 24 drugs in the angiotensin 2 receptor blocker class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 243,200 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 1.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Hypertension | 2,060 | 20.2% |
| Migraine | 2,052 | 20.1% |
| Rheumatoid arthritis | 267 | 2.6% |
| Cardiac failure | 82 | 0.8% |
| Foetal exposure during pregnancy | 68 | 0.7% |
| Essential hypertension | 39 | 0.4% |
The indication field is filled in by the reporter and is often blank; shares are of all 10,197 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Candesartan reports |
|---|---|---|
| Prednisone | 2,529 | 24.8% |
| Cosentyx | 2,174 | 21.3% |
| Acetaminophen | 2,148 | 21.1% |
| Methotrexate | 2,099 | 20.6% |
| Rituximab | 2,058 | 20.2% |
| Aimovig | 2,056 | 20.2% |
| Naproxen | 2,047 | 20.1% |
| Folic acid | 2,028 | 19.9% |
| Leflunomide | 1,987 | 19.5% |
| Ramipril | 1,825 | 17.9% |
Other products listed in reports where Candesartan is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Candesartan | Angiotensin 2 receptor blocker | All reports |
|---|---|---|---|
| Reports as suspect product | 10,197 | 243,200 | 20,646,523 |
| Share of that pool | — | 4.2% | 0.1% |
| Reports, latest 12 months | 1,487 | — | 1,332,454 |
| Marked serious | 98.6% | 67.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 255 | 111 | 91 |
| Hospitalisation recorded, per 1,000 reports | 577 | 287 | 213 |
| Consumer-filed share | 16.8% | 54.2% | 45.8% |
| Top term, share of reports | Off label use 21.5% | median 1.8% | 4.1% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the angiotensin 2 receptor blocker class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Entresto | brand | 105,173 | 1,285 | 49.3% |
| Diovan | brand | 17,179 | 133 | 91.7% |
| Valsartan | generic | 16,935 | 923 | 83.8% |
| Losartan | generic | 15,176 | 1,137 | 80.1% |
| Irbesartan | generic | 10,055 | 692 | 93.7% |
| Benicar | brand | 8,370 | 79 | 69.4% |
| Losartan potassium | generic | 6,725 | 246 | 73% |
| Exforge | brand | 6,266 | 108 | 95.3% |
| Diovan HCT | brand | 5,670 | 30 | 95.3% |
| Filspari | brand | 5,598 | 2,908 | 16.1% |
| Candesartan cilexetil | generic | 5,311 | 622 | 97.6% |
| Cozaar | brand | 4,913 | 60 | 70.2% |
| Olmesartan medoxomil | generic | 4,777 | 169 | 90.6% |
| Telmisartan | generic | 4,666 | 357 | 91.2% |
| Atacand | brand | 4,597 | 48 | 76.6% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Candesartan reports
How many adverse event reports has FDA received for Candesartan?
10,197 reports list Candesartan as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 1,487 of them arrived in the latest 12 months. Another 25,689 list it only as a concomitant medication.
What reactions are recorded in Candesartan reports?
off label use (21.5%), fatigue (16.8%), pain (16.7%), dyspnoea (16.2%) and drug ineffective (16.2%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Candesartan was responsible.
How serious are the reports?
98.6% are marked serious by the reporter. Among the outcomes recorded, 25.5% of reports include death and 57.7% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (45.8%), physician (24.4%) and consumer or non-health professional (16.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Candesartan rising?
1,487 reports in the 12 months to June 2026, down 22% from 1,909 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Candesartan was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Candesartan?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Candesartan as a suspect or interacting product; reports listing it only as a concomitant medication (25,689) are excluded. 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.