Atacand: adverse event reports filed with FDA

4,597

reports as suspect product

0% of all reports · about 204 a year

48

reports, 12 months to June 2026

75 in the 12 months before

76.6%

marked serious by the reporter

67.6% across the class

5.8%

record death among outcomes, as reported

266 reports · not verified by FDA

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 Atacand reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Blood pressure increaseda raised blood pressure reading11.2%517
2. Drug ineffectivethe medicine did not work as expected9.9%456
3. Malaisegeneral feeling of being unwell8.6%397
4. Hypertensionhigh blood pressure8.3%383
5. Headachehead pain7.8%360
6. Fatiguetiredness7.2%332
7. Dizzinesslight-headedness or unsteadiness6.6%304
8. Nauseafeeling sick6.5%298
9. Falla fall6.4%292
10. Coughcough5.6%258
11. Astheniaweakness or lack of energy5.6%257
12. Hypotensionlow blood pressure5.5%255
13. Palpitationsawareness of the heartbeat4.8%221
14. Cerebrovascular accidentstroke4.6%211
15. Vomitingbeing sick4.4%204
16. Arterial occlusive disease4.4%200
17. Drug dose omissiona dose was missed4.3%199
18. Cataractclouding of the eye lens4.3%196
19. Confusional stateconfusion4.2%191
20. Painpain, site not specified4.1%188
21. Pneumonialung infection4%184
22. Dyspnoeashortness of breath4%182
23. Sinusitissinus infection4%182
24. Anxietyanxiety3.9%180
25. Arthritis3.9%180
26. Chest discomfortchest discomfort3.9%178
27. Angina pectoris3.8%174
28. Drug interactionan interaction between medicines3.8%174
29. Off label useused for a purpose or in a way not on the label3.7%171
30. Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease3.7%168

Top 30 of 857 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 35.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,597 reports.

Drugs most often listed in the same reports

Other products listed in reports where Atacand 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

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

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.

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 Atacand as a suspect or interacting product; reports listing it only as a concomitant medication (9,141) 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.