Doxylamine succinate adverse event reports that FDA received

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

Name type: Generic name
Class: Antihistamine
Also reported as: Doxylamine Succinate 25 Mg 441

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.

Reports on file

From February 2004 to June 2026, FDA received 1,858 adverse event reports that name Doxylamine succinate. In these reports the drug is a suspect or interacting product.

In the same period, 434 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 252 reports in the 12 months to June 2026 and 161 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

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 Doxylamine succinate 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 1 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.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 23 reports that name Doxylamine succinate.
In January to March 2026, FDA received 19.
In April to June 2025, FDA received 14.

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 135 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 1,779 of the 1,858 reports (95.7%).

The reports of the other years are not in the counts.

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 135 terms.

Reaction terms in the reports that name Doxylamine succinate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,858 reports
Drug ineffectivethe medicine did not work as expected	463	24.9%
Somnolencedrowsiness	245	13.2%
Toxicity to various agentspoisoning or toxic effect of one or more substances	185	10%
Underdoseless than the intended dose	97	5.2%
Drug abusemisuse of a medicine	80	4.3%
Incorrect dose administeredthe wrong dose was given	74	4%
Overdosea dose above the recommended amount	73	3.9%
Fatiguetiredness	70	3.8%
Deaththe patient died; cause not stated by this term	68	3.7%
Intentional overdosea deliberate overdose	56	3%
Feeling abnormalfeeling odd or not right	52	2.8%
Completed suicidedeath by suicide	50	2.7%
Coma	45	2.4%
Dizzinesslight-headedness or unsteadiness	42	2.3%
Therapeutic product effect decreased	42	2.3%
Therapeutic product effect incomplete	42	2.3%
Off label useused for a purpose or in a way not on the label	37	2%
Exposure to toxic agent	35	1.9%
Accidental overdosean accidental overdose	34	1.8%
Pneumonialung infection	34	1.8%
Headachehead pain	33	1.8%
Acute kidney injurysudden loss of kidney function	32	1.7%
Condition aggravatedthe condition being treated got worse	30	1.6%
Exposure during pregnancythe medicine was taken during pregnancy	29	1.6%
Poisoning deliberate	28	1.5%
Rhabdomyolysismuscle breakdown	28	1.5%
Hangover	27	1.5%
Therapeutic product effect delayed	27	1.5%
Wrong technique in product usage processthe product was used in the wrong way	27	1.5%
Insomniadifficulty sleeping	25	1.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	25	1.3%
Hypotensionlow blood pressure	24	1.3%
Anxiety	22	1.2%
Abnormal dreamsunusual dreams	21	1.1%
Cardio-respiratory arrestthe heart and breathing stopped	21	1.1%
Myalgiamuscle pain	21	1.1%
Tachycardiafast heart rate	21	1.1%
Vomitingbeing sick	21	1.1%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	20	1.1%
Poor quality sleep	20	1.1%
Agitationrestlessness	19	1%
Mydriasis	19	1%
Nightmarenightmares	19	1%
Drug interactionan interaction between medicines	18	1%
Suicide attempta suicide attempt	18	1%
Drug effect less than expected	17	0.9%
Malaisegeneral feeling of being unwell	17	0.9%
Therapeutic product effect variable	17	0.9%
Incorrect product administration duration	16	0.9%
Intentional product use issuedeliberate use not as intended	16	0.9%

Download all 135 terms of Doxylamine succinate (CSV)

The counts add to more than 1,858 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 Doxylamine succinate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Doxylamine succinate (this page)	Generic name	1,858
Unisom SleepTabs	Brand name	1,559

Sum of the separately reported names: 3,417. 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 Doxylamine succinate, 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	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	3	3	2	1	0	0	0	0	0
2005	7	7	6	0	0	0	0	1	0
2006	4	4	3	0	0	1	0	0	0
2007	8	8	8	0	0	0	0	2	0
2008	16	16	9	2	4	0	0	3	0
2009	10	10	7	0	3	0	0	5	0
2010	17	17	4	0	11	0	0	3	0
2011	34	34	27	2	2	0	2	9	0
2012	28	28	19	1	6	0	3	6	0
2013	12	8	1	0	2	0	1	6	4
2014	18	16	14	1	2	0	0	3	2
2015	71	36	33	0	3	0	0	0	35
2016	28	9	4	0	3	0	0	3	19
2017	77	50	38	2	14	0	2	1	27
2018	51	34	17	3	14	0	1	12	17
2019	108	44	14	4	16	0	2	23	64
2020	246	32	11	9	9	0	5	18	214
2021	305	56	19	1	15	0	7	27	249
2022	157	73	20	0	27	0	0	45	84
2023	175	102	35	6	32	0	4	58	73
2024	166	92	23	12	48	1	1	54	74
2025	268	77	23	13	32	0	1	50	191
2026	49	48	18	2	15	0	1	31	1

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 Doxylamine succinate, 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 Doxylamine succinate, by the year in which FDA received them
Year	Reports
2004	3
2005	7
2006	4
2007	7
2008	16
2009	11
2010	16
2011	27
2012	37
2013	11
2014	18
2015	72
2016	29
2017	83
2018	50
2019	111
2020	245
2021	316
2022	150
2023	187
2024	161
2025	255
2026	42

Reports that name Doxylamine succinate, 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 Doxylamine succinate
Age	Reports	Share
Under 2	25	1.3%
2 to 11	12	0.6%
12 to 17	27	1.5%
18 to 44	321	17.3%
45 to 64	191	10.3%
65 to 74	81	4.4%
75 and over	86	4.6%
Age not given	1,115	60%

Sex of the patient in the reports that name Doxylamine succinate
Sex	Reports	Share
Female	566	30.5%
Male	359	19.3%
Unknown or not given	933	50.2%

Type of reporter in the reports that name Doxylamine succinate
Reporter	Reports	Share
Physician	321	17.3%
Pharmacist	132	7.1%
Other health professional	224	12.1%
Lawyer	3	0.2%
Consumer or non-health professional	1,160	62.4%
Not given	18	1%

Age and sex are as the report gives them. The reporter is the primary source in the report. 70.7% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Doxylamine succinate record
Indication as recorded (MedDRA)	Reports	Share
Insomnia	626	33.7%
Drug abuse	30	1.6%
Sleep disorder	27	1.5%
Suspected suicide	24	1.3%
Suicide attempt	21	1.1%
Initial insomnia	18	1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,858 reports.

Drugs in the same reports

Other drugs that the reports of Doxylamine succinate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	138
Alcohol	69
Alprazolam	78
Codeine	90
Diazepam	93
Mirtazapine	39
Ondansetron	38
Oxazepam	63
Oxycodone	40
Pregabalin	67

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

Unisom SleepTabs same ingredient
Hydroxyzine same class
Hydroxyzine hcl same class
Hydroxyzine hydrochloride same class
Doxylamine next in the A to Z list
Doxylamine Succinate Pyridoxine Hydrochloride next in the A to Z list
Doxycycline monohydrate next in the A to Z list
Dramamine next in the A to Z list
Doxycycline Hydrochloride next in the A to Z list
Droleptan next in the A to Z list
Doxycycline hyclate next in the A to Z list
Dronabinol 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 Doxylamine succinateThe 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. Doxylamine succinate: adverse event reports that FDA received. https://reportedreactions.com/drug/doxylamine-succinate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 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 1 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 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Doxylamine succinate as a suspect or interacting product. The 434 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 Doxylamine succinate 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 Doxylamine succinate?

No. It is a count of what people reported to FDA: 1,858 reports from February 2004 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?

Consumer or non-health professional (62.4%), physician (17.3%) and other health professional (12.1%). 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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