Doxylamine adverse event reports that FDA received

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

Name type: Product name as reported

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 June 2004 to June 2026, FDA received 1,483 adverse event reports that name Doxylamine. The name is as reporters wrote it. In these reports the drug is a suspect or interacting product.

In the same period, 380 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 66 reports in the 12 months to June 2026 and 74 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, 66 (under 0.1%) name Doxylamine. Reports from consumers or other non-health professionals were 3.8% of the reports that name Doxylamine 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 Doxylamine 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 10 reports that name Doxylamine.
In January to March 2026, FDA received 20.
In April to June 2025, FDA received 20.

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 140 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 1,433 of the 1,483 reports (96.6%).

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 140 terms.

Reaction terms in the reports that name Doxylamine, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,483 reports
Toxicity to various agentspoisoning or toxic effect of one or more substances	442	29.8%
Drug abusemisuse of a medicine	347	23.4%
Completed suicidedeath by suicide	318	21.4%
Deaththe patient died; cause not stated by this term	130	8.8%
Drug interactionan interaction between medicines	81	5.5%
Cardio-respiratory arrestthe heart and breathing stopped	75	5.1%
Overdosea dose above the recommended amount	74	5%
Cardiac arrestthe heart stopped	62	4.2%
Intentional product misusedeliberate use not as intended	62	4.2%
Drug ineffectivethe medicine did not work as expected	60	4%
Somnolencedrowsiness	56	3.8%
Respiratory arrestbreathing stopped	52	3.5%
Suicide attempta suicide attempt	45	3%
Coma	44	3%
Intentional overdosea deliberate overdose	42	2.8%
Vomitingbeing sick	36	2.4%
Exposure during pregnancythe medicine was taken during pregnancy	33	2.2%
Accidental overdosean accidental overdose	32	2.2%
Off label useused for a purpose or in a way not on the label	32	2.2%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	31	2.1%
Accidental death	29	2%
Poisoning	29	2%
Exposure via ingestion	27	1.8%
Pulmonary oedemafluid in the lungs	26	1.8%
Rhabdomyolysismuscle breakdown	26	1.8%
Falla fall	25	1.7%
Condition aggravatedthe condition being treated got worse	24	1.6%
Confusional stateconfusion	22	1.5%
Intentional drug misuse	21	1.4%
Suspected suicide	21	1.4%
Tachycardiafast heart rate	20	1.3%
Agitationrestlessness	19	1.3%
Brain oedema	19	1.3%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	19	1.3%
Unresponsive to stimuli	18	1.2%
Depressed level of consciousness	16	1.1%
Dry mouth	16	1.1%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	16	1.1%
Toothachetooth pain	16	1.1%
Drug dependencedependence on a medicine	15	1%
Fatiguetiredness	15	1%
Therapy non-responderthe treatment did not work	15	1%
Central pain syndrome	14	0.9%
Hyperaesthesia	14	0.9%
Live birth	14	0.9%
Bradycardiaslow heart rate	13	0.9%
Disorientation	13	0.9%
Nauseafeeling sick	13	0.9%
Product use in unapproved indicationused for a purpose not on the label	13	0.9%
Prostatic pain	13	0.9%

Download all 140 terms of Doxylamine (CSV)

The counts add to more than 1,483 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.

Outcomes by year

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

Outcomes in the reports that name Doxylamine, 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	11	11	10	0	1	0	0	3	0
2005	6	6	5	0	1	0	0	1	0
2006	8	8	7	0	1	0	0	1	0
2007	10	10	8	0	2	0	0	0	0
2008	12	12	10	0	4	0	0	2	0
2009	7	7	7	0	0	0	0	1	0
2010	15	15	13	1	2	0	0	2	0
2011	27	27	26	0	2	0	2	4	0
2012	8	8	5	0	3	0	0	1	0
2013	51	51	46	0	4	0	0	7	0
2014	191	188	172	3	13	0	1	14	3
2015	260	259	254	1	6	0	0	27	1
2016	46	46	39	0	9	1	1	12	0
2017	46	46	36	1	15	0	0	15	0
2018	64	61	45	6	11	0	2	26	3
2019	70	67	36	9	27	0	2	31	3
2020	77	77	50	10	26	0	2	47	0
2021	92	90	76	0	23	0	4	52	2
2022	131	129	89	5	45	0	0	70	2
2023	93	92	39	11	38	0	1	62	1
2024	104	102	44	8	48	2	1	73	2
2025	118	110	24	21	69	1	0	81	8
2026	36	35	18	2	20	0	0	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, 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, by the year in which FDA received them
Year	Reports
2004	7
2005	10
2006	7
2007	11
2008	10
2009	9
2010	13
2011	25
2012	17
2013	57
2014	198
2015	266
2016	53
2017	50
2018	66
2019	74
2020	83
2021	79
2022	138
2023	111
2024	83
2025	86
2026	30

Reports that name Doxylamine, 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
Age	Reports	Share
Under 2	22	1.5%
2 to 11	17	1.1%
12 to 17	36	2.4%
18 to 44	718	48.4%
45 to 64	431	29.1%
65 to 74	62	4.2%
75 and over	35	2.4%
Age not given	162	10.9%

Sex of the patient in the reports that name Doxylamine
Sex	Reports	Share
Female	722	48.7%
Male	635	42.8%
Unknown or not given	126	8.5%

Type of reporter in the reports that name Doxylamine
Reporter	Reports	Share
Physician	499	33.6%
Pharmacist	364	24.5%
Other health professional	506	34.1%
Lawyer	4	0.3%
Consumer or non-health professional	57	3.8%
Not given	53	3.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 65.8% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Doxylamine record
Indication as recorded (MedDRA)	Reports	Share
Suicide attempt	51	3.4%
Depression	30	2%
Insomnia	28	1.9%
Morning sickness	15	1%
Sleep disorder	12	0.8%
Intentional overdose	10	0.7%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,483 reports.

Drugs in the same reports

Other drugs that the reports of Doxylamine name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	315
Alprazolam	193
Citalopram	147
Cocaine	124
Dextromethorphan	240
Diazepam	193
Diphenhydramine	276
Fluoxetine	127
Oxycodone	160
Zolpidem	126

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

Doxycycline monohydrate next in the A to Z list
Doxylamine succinate next in the A to Z list
Doxycycline Hydrochloride next in the A to Z list
Doxylamine Succinate Pyridoxine Hydrochloride next in the A to Z list
Doxycycline hyclate next in the A to Z list
Dramamine next in the A to Z list
Doxycycline Calcium next in the A to Z list
Droleptan next in the A to Z list
Doxycycline next in the A to Z list
Dronabinol next in the A to Z list
Doxorubicine Teva next in the A to Z list
Dronedarone next in the A to Z list

These links are for navigation. No count selected them.

Official pages

DailyMed labels for DoxylamineThe 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: adverse event reports that FDA received. https://reportedreactions.com/drug/doxylamine/ 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 Doxylamine as a suspect or interacting product. The 380 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 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?

No. It is a count of what people reported to FDA: 1,483 reports from June 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?

Other health professional (34.1%), physician (33.6%) and pharmacist (24.5%). 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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