Dimenhydrinate adverse event reports that FDA received

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

Name type: Generic name
Class: Histamine-1 receptor antagonist
Also reported as: Dimenhydrinate Injection

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 2004 to June 2026, FDA received 1,087 adverse event reports that name Dimenhydrinate. In these reports the drug is a suspect or interacting product.

In the same period, 4,162 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 121 reports in the 12 months to June 2026 and 134 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, 121 (under 0.1%) name Dimenhydrinate. Reports from other health professionals were 55.9% of the reports that name Dimenhydrinate and 19.7% 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 Dimenhydrinate 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 25 reports that name Dimenhydrinate.
In January to March 2026, FDA received 47.
In April to June 2025, FDA received 30.

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 287 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 1,022 of the 1,087 reports (94%).

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 287 terms.

Reaction terms in the reports that name Dimenhydrinate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,087 reports
Drug ineffectivethe medicine did not work as expected	210	19.3%
Nauseafeeling sick	149	13.7%
Off label useused for a purpose or in a way not on the label	144	13.2%
Falla fall	137	12.6%
Pyrexiafever	125	11.5%
Drug dependencedependence on a medicine	119	10.9%
Respiratory depressionslow or shallow breathing	115	10.6%
Vomitingbeing sick	112	10.3%
Depressed moodlow mood	107	9.8%
Insomniadifficulty sleeping	100	9.2%
Dyspnoeashortness of breath	98	9%
Malaisegeneral feeling of being unwell	98	9%
Product prescribing error	98	9%
Product use in unapproved indicationused for a purpose not on the label	98	9%
Drug abusemisuse of a medicine	95	8.7%
Loss of personal independence in daily activities	95	8.7%
Chest discomfort	93	8.6%
Fatiguetiredness	93	8.6%
Foetal exposure during pregnancythe unborn baby was exposed to the medicine	91	8.4%
Chest pain	90	8.3%
Febrile neutropeniafever with low white blood cells	86	7.9%
Angina pectoris	83	7.6%
Cough	83	7.6%
Weight decreasedweight loss	83	7.6%
Asthma	82	7.5%
Nasopharyngitisa cold	81	7.5%
Wheezing	81	7.5%
Influenzaflu	80	7.4%
Rhinorrhoeaa runny nose	80	7.4%
Sleep disorder due to a general medical condition	78	7.2%
Product use issuea problem in how the product was used	76	7%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	73	6.7%
Intentional product misusedeliberate use not as intended	67	6.2%
Urinary retentionbeing unable to empty the bladder	67	6.2%
Somnolencedrowsiness	66	6.1%
Dizzinesslight-headedness or unsteadiness	65	6%
Condition aggravatedthe condition being treated got worse	64	5.9%
Appetite disorder	61	5.6%
Lower respiratory tract infectiona chest infection	61	5.6%
Respiration abnormal	61	5.6%
Stress	61	5.6%
Upper respiratory tract infectiona cold or similar infection	61	5.6%
Depressive symptom	60	5.5%
Dyspnoea exertional	60	5.5%
Heart sounds	60	5.5%
Injurya physical injury	60	5.5%
Nasal congestiona blocked nose	60	5.5%
Productive cougha cough with phlegm	60	5.5%
Prolonged expiration	60	5.5%
Rales	60	5.5%

Download all 287 terms of Dimenhydrinate (CSV)

The counts add to more than 1,087 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 Dimenhydrinate with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Dimenhydrinate (this page)	Generic name	1,087
Gravol	Brand name	968

Sum of the separately reported names: 2,055. 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 Dimenhydrinate, 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	5	5	0	0	5	0	0	1	0
2005	3	3	0	0	1	0	0	2	0
2006	2	2	0	0	0	0	0	2	0
2007	3	3	2	0	1	0	0	0	0
2008	2	2	1	0	1	0	0	1	0
2009	12	12	1	1	2	0	6	6	0
2010	10	9	1	1	5	0	0	8	1
2011	19	19	9	1	16	0	0	11	0
2012	10	9	0	0	8	0	0	7	1
2013	12	12	1	2	8	1	1	7	0
2014	31	31	16	1	19	0	1	14	0
2015	10	10	2	0	5	0	0	8	0
2016	6	5	2	0	3	0	0	4	1
2017	11	10	1	2	4	0	0	6	1
2018	18	17	6	2	6	2	2	12	1
2019	55	52	10	5	20	5	0	41	3
2020	97	94	25	9	43	14	1	67	3
2021	123	122	23	6	79	11	11	99	1
2022	96	94	10	13	55	11	6	73	2
2023	152	152	12	20	87	7	11	145	0
2024	136	134	6	15	70	3	4	117	2
2025	164	163	6	11	45	4	19	144	1
2026	110	110	16	25	33	6	14	90	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 Dimenhydrinate, 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 Dimenhydrinate, by the year in which FDA received them
Year	Reports
2004	4
2005	4
2006	2
2007	3
2008	2
2009	11
2010	10
2011	20
2012	10
2013	13
2014	34
2015	13
2016	10
2017	15
2018	33
2019	75
2020	122
2021	140
2022	87
2023	159
2024	130
2025	118
2026	72

Reports that name Dimenhydrinate, 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 Dimenhydrinate
Age	Reports	Share
Under 2	26	2.4%
2 to 11	139	12.8%
12 to 17	44	4%
18 to 44	214	19.7%
45 to 64	201	18.5%
65 to 74	162	14.9%
75 and over	45	4.1%
Age not given	256	23.6%

Sex of the patient in the reports that name Dimenhydrinate
Sex	Reports	Share
Female	567	52.2%
Male	348	32%
Unknown or not given	172	15.8%

Type of reporter in the reports that name Dimenhydrinate
Reporter	Reports	Share
Physician	263	24.2%
Pharmacist	33	3%
Other health professional	608	55.9%
Lawyer	1	0.1%
Consumer or non-health professional	158	14.5%
Not given	24	2.2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 3.3% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Dimenhydrinate record
Indication as recorded (MedDRA)	Reports	Share
Nausea	96	8.8%
Constipation	80	7.4%
Vomiting	65	6%
Premedication	61	5.6%
Morning sickness	47	4.3%
Anxiety	32	2.9%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,087 reports.

Drugs in the same reports

Other drugs that the reports of Dimenhydrinate name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	300
Baclofen	135
Diphenhydramine	147
Ergocalciferol	146
Furosemide	162
Gabapentin	185
Lorazepam	201
Ondansetron	188
Pantoprazole	276
Prednisone	177

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

Gravol same ingredient
Desloratadine same class
Dimetapp same class
Coricidin HBP Cough and Cold same class
Diphenhydramine same class
Clarinex same class
Diphenhydramine hcl same class
Diltiazem hydrochloride next in the A to Z list
Diltiazem hcl next in the A to Z list
Dimethyl fumarate next in the A to Z list
Diltiazem next in the A to Z list
Dinoprostone 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 DimenhydrinateThe 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. Dimenhydrinate: adverse event reports that FDA received. https://reportedreactions.com/drug/dimenhydrinate/ 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 Dimenhydrinate as a suspect or interacting product. The 4,162 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 Dimenhydrinate 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 Dimenhydrinate?

No. It is a count of what people reported to FDA: 1,087 reports from July 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 (55.9%), physician (24.2%) and consumer or non-health professional (14.5%). 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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