Samsca: adverse event reports filed with FDA

4,598

reports as suspect product

0% of all reports · about 271 a year

41

reports, 12 months to June 2026

84 in the 12 months before

78.6%

marked serious by the reporter

76.5% across the class

23.3%

record death among outcomes, as reported

1,070 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 Samsca reports recording the termmedian drug in vasopressin v2 receptor antagonist

1. Off label useused for a purpose or in a way not on the label11.7%540
2. Deaththe patient died; cause not stated by this term8.5%389
3. Hypernatraemia6.3%288
4. Cardiac failureheart failure5.6%257
5. Renal impairmentreduced kidney function5.3%245
6. Rapid correction of hyponatraemia4.5%206
7. Blood sodium decreased4.3%198
8. Dehydrationdehydration3.9%179
9. Incorrect drug administration duration3.8%176
10. Hepatic function abnormal3.8%174
11. Product use in unapproved indicationused for a purpose not on the label3.6%166
12. Blood urea increased3.4%157
13. Hyponatraemialow blood sodium3.2%145
14. Underdoseless than the intended dose3.2%145
15. Inappropriate schedule of drug administrationthe medicine was taken at the wrong times3.1%141
16. Product use issuea problem in how the product was used2.8%128
17. Wrong technique in product usage processthe product was used in the wrong way2.8%127
18. Thirst2.7%124
19. Blood creatinine increasedraised creatinine, a kidney test2.4%111
20. Blood sodium increased2.2%103
21. Hospitalisationadmission to hospital2.2%102
22. Pneumonialung infection2.1%96
23. Inappropriate schedule of product administrationthe product was taken at the wrong times2%92
24. Incorrect product administration duration1.9%88
25. Blood pressure decreaseda low blood pressure reading1.7%77
26. Altered state of consciousness1.6%74
27. Wrong technique in drug usage processthe medicine was used in the wrong way1.6%72
28. No adverse eventno adverse event was reported1.5%71
29. Platelet count decreasedlow platelet count1.5%70
30. Dyspnoeashortness of breath1.5%68

Top 30 of 498 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 2 drugs in the vasopressin v2 receptor antagonist 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 11,505 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. 41.3% 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 4,598 reports.

Drugs most often listed in the same reports

Other products listed in reports where Samsca 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 vasopressin v2 receptor antagonist 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 Samsca as a suspect or interacting product; reports listing it only as a concomitant medication (1,856) 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.