Losartan: adverse event reports filed with FDA

15,176

reports as suspect product

0.1% of all reports · about 675 a year

1,137

reports, 12 months to June 2026

1,030 in the 12 months before

80.1%

marked serious by the reporter

67.6% across the class

11.2%

record death among outcomes, as reported

1,707 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 Losartan reports recording the termmedian drug in angiotensin 2 receptor blocker

1. Dizzinesslight-headedness or unsteadiness6.8%1,036
2. Drug ineffectivethe medicine did not work as expected6.8%1,029
3. Acute kidney injurysudden loss of kidney function6%910
4. Headachehead pain5.9%894
5. Hypotensionlow blood pressure5.6%852
6. Dyspnoeashortness of breath5.5%839
7. Completed suicidedeath by suicide5.5%832
8. Malaisegeneral feeling of being unwell5.5%830
9. Fatiguetiredness5.3%810
10. Coughcough5.2%789
11. Diarrhoealoose or frequent stools4.6%698
12. Hypertensionhigh blood pressure4.3%654
13. Painpain, site not specified4%607
14. Nauseafeeling sick4%606
15. Drug interactionan interaction between medicines3.8%577
16. Blood pressure increaseda raised blood pressure reading3.7%567
17. Arthralgiajoint pain3.6%541
18. Astheniaweakness or lack of energy3.3%499
19. Toxicity to various agentspoisoning or toxic effect of one or more substances3.2%481
20. Weight decreasedweight loss3%461
21. Hyperkalaemiahigh blood potassium2.9%445
22. Abdominal pain upperupper stomach pain2.9%444
23. Falla fall2.8%423
24. Chest painchest pain2.8%421
25. Vomitingbeing sick2.7%410
26. Off label useused for a purpose or in a way not on the label2.6%399
27. Drug hypersensitivityan allergic-type reaction to a medicine2.6%392
28. Feeling abnormalfeeling odd or not right2.6%391
29. Pruritusitching2.5%383
30. Rashskin rash2.5%380

Top 30 of 1,889 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. 52% 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 15,176 reports.

Drugs most often listed in the same reports

Other products listed in reports where Losartan 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 Losartan as a suspect or interacting product; reports listing it only as a concomitant medication (110,449) 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.