Samsca (tolvaptan) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Samsca
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Tolvaptan
Class: Vasopressin V2 receptor antagonist
Also reported as: Samsca Tablet

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From July 2009 to June 2026, FDA received 4,598 adverse event reports that name Samsca. In these reports the drug is a suspect or interacting product.

In the same period, 1,856 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 41 reports in the 12 months to June 2026 and 84 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 41 (under 0.1%) name Samsca. Reports from consumers or other non-health professionals were 12.2% of the reports that name Samsca and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Samsca is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 9 reports that name Samsca.
In January to March 2026, FDA received 9.
In April to June 2025, FDA received 15.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 248 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 4,598 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 248 terms.

Reaction terms in the reports that name Samsca, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,598 reports
Off label useused for a purpose or in a way not on the label	540	11.7%
Deaththe patient died; cause not stated by this term	389	8.5%
Hypernatraemia	288	6.3%
Cardiac failureheart failure	257	5.6%
Renal impairmentreduced kidney function	245	5.3%
Rapid correction of hyponatraemia	206	4.5%
Blood sodium decreased	198	4.3%
Dehydration	179	3.9%
Incorrect drug administration duration	176	3.8%
Hepatic function abnormal	174	3.8%
Product use in unapproved indicationused for a purpose not on the label	166	3.6%
Blood urea increased	157	3.4%
Hyponatraemialow blood sodium	145	3.2%
Underdoseless than the intended dose	145	3.2%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	141	3.1%
Product use issuea problem in how the product was used	128	2.8%
Wrong technique in product usage processthe product was used in the wrong way	127	2.8%
Thirst	124	2.7%
Blood creatinine increasedraised creatinine, a kidney test	111	2.4%
Blood sodium increased	103	2.2%
Hospitalisationadmission to hospital	102	2.2%
Pneumonialung infection	96	2.1%
Inappropriate schedule of product administrationthe product was taken at the wrong times	92	2%
Incorrect product administration duration	88	1.9%
Blood pressure decreaseda low blood pressure reading	77	1.7%
Altered state of consciousness	74	1.6%
Wrong technique in drug usage processthe medicine was used in the wrong way	72	1.6%
No adverse eventno adverse event was reported	71	1.5%
Platelet count decreasedlow platelet count	70	1.5%
Dyspnoeashortness of breath	68	1.5%
Condition aggravatedthe condition being treated got worse	65	1.4%
Hepatic encephalopathy	65	1.4%
Pyrexiafever	63	1.4%
Liver disorder	62	1.3%
Hyperkalaemiahigh blood potassium	60	1.3%
Falla fall	58	1.3%
Malaisegeneral feeling of being unwell	57	1.2%
Cerebral infarction	56	1.2%
Acute kidney injurysudden loss of kidney function	53	1.2%
Decreased appetitereduced appetite	52	1.1%
Drug ineffectivethe medicine did not work as expected	52	1.1%
Glomerular filtration rate decreasedreduced kidney filtering	52	1.1%
Hepatotoxicityliver injury	52	1.1%
Nauseafeeling sick	50	1.1%
Cardiac failure congestivecongestive heart failure	49	1.1%
Hypotensionlow blood pressure	48	1%
Confusional stateconfusion	47	1%
Diarrhoealoose or frequent stools	47	1%
Dizzinesslight-headedness or unsteadiness	47	1%
Renal failurekidney failure	47	1%

Download all 248 terms of Samsca (CSV)

The counts add to more than 4,598 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Tolvaptan with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Tolvaptan	Generic name	6,907
Samsca (this page)	Brand name	4,598

Sum of the separately reported names: 11,505. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Samsca, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Other Serious (Important Medical Events)	Not serious
2009	13	5	5	0	0	0	0	8
2010	51	46	26	0	9	0	15	5
2011	121	104	38	8	24	2	55	17
2012	271	257	78	11	73	7	157	14
2013	373	367	100	10	89	10	260	6
2014	277	274	88	15	65	13	194	3
2015	183	174	38	4	74	3	106	9
2016	408	323	105	12	126	10	169	85
2017	508	377	133	18	150	9	161	131
2018	530	289	88	15	132	13	156	241
2019	601	301	91	10	120	12	169	300
2020	276	196	53	13	76	2	115	80
2021	326	298	96	12	94	8	211	28
2022	247	214	51	8	75	4	165	33
2023	174	173	32	4	63	1	153	1
2024	148	129	31	1	42	2	115	19
2025	70	66	13	3	28	0	48	4
2026	21	21	4	0	9	0	14	0

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Samsca, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Samsca, by the year in which FDA received them
Year	Reports
2009	14
2010	40
2011	122
2012	333
2013	391
2014	274
2015	200
2016	431
2017	485
2018	516
2019	581
2020	256
2021	339
2022	246
2023	159
2024	131
2025	62
2026	18

Reports that name Samsca, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Samsca
Age	Reports	Share
Under 2	7	0.2%
2 to 11	15	0.3%
12 to 17	14	0.3%
18 to 44	193	4.2%
45 to 64	805	17.5%
65 to 74	594	12.9%
75 and over	1,416	30.8%
Age not given	1,554	33.8%

Sex of the patient in the reports that name Samsca
Sex	Reports	Share
Female	1,834	39.9%
Male	1,986	43.2%
Unknown or not given	778	16.9%

Type of reporter in the reports that name Samsca
Reporter	Reports	Share
Physician	2,090	45.5%
Pharmacist	1,243	27%
Other health professional	489	10.6%
Lawyer	1	under 0.1%
Consumer or non-health professional	559	12.2%
Not given	216	4.7%

Age and sex are as the report gives them. The reporter is the primary source in the report. 41.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Samsca record
Indication as recorded (MedDRA)	Reports	Share
Hyponatraemia	589	12.8%
Cardiac failure	509	11.1%
Congenital cystic kidney disease	276	6%
Inappropriate antidiuretic hormone secretion	264	5.7%
Fluid retention	243	5.3%
Cardiac failure congestive	117	2.5%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,598 reports.

Drugs in the same reports

Other drugs that the reports of Samsca name, in any role, in order of name
Drug	Reports that name the two
Aldactone	132
Aspirin	110
Bayaspirin	126
Carvedilol	133
Entresto	131
Furosemide	535
Lansoprazole	104
Lasix	522
Spironolactone	320
Warfarin	128

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Tolvaptan same ingredient
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Salicylates next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for SamscaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Samsca: adverse event reports that FDA received. https://reportedreactions.com/drug/samsca/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Samsca as a suspect or interacting product. The 1,856 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Samsca was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Samsca?

No. It is a count of what people reported to FDA: 4,598 reports from July 2009 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (45.5%), pharmacist (27%) and consumer or non-health professional (12.2%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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