Gravol (dimenhydrinate) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Dimenhydrinate
Class: Histamine-1 receptor antagonist
Also reported as: Gravol Tab

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 November 2006 to June 2026, FDA received 968 adverse event reports that name Gravol. In these reports the drug is a suspect or interacting product.

In the same period, 3,924 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 127 reports in the 12 months to June 2026 and 108 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, 127 (under 0.1%) name Gravol. Reports from other health professionals were 53.6% of the reports that name Gravol 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 Gravol 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 23 reports that name Gravol.
In January to March 2026, FDA received 32.
In April to June 2025, FDA received 17.

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 313 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 925 of the 968 reports (95.6%).

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 313 terms.

Reaction terms in the reports that name Gravol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 968 reports
Fatiguetiredness	503	52%
Nauseafeeling sick	416	43%
Malaisegeneral feeling of being unwell	382	39.5%
Anxiety	376	38.8%
Vomitingbeing sick	363	37.5%
Cystitis	327	33.8%
Dizzinesslight-headedness or unsteadiness	299	30.9%
Pneumonialung infection	297	30.7%
Headachehead pain	296	30.6%
Chest discomfort	252	26%
Blood pressure increaseda raised blood pressure reading	236	24.4%
Painpain, site not specified	236	24.4%
Palpitationsawareness of the heartbeat	230	23.8%
Abdominal painstomach or belly pain	225	23.2%
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease	223	23%
Sinusitissinus infection	218	22.5%
Diarrhoealoose or frequent stools	215	22.2%
Pyrexiafever	215	22.2%
Nasopharyngitisa cold	212	21.9%
Cough	209	21.6%
Migraine	207	21.4%
Cataractclouding of the eye lens	205	21.2%
Gangrenedeath of tissue	203	21%
Arterial occlusive disease	202	20.9%
Angina pectoris	201	20.8%
Arthritis	200	20.7%
Astheniaweakness or lack of energy	198	20.5%
Feeling abnormalfeeling odd or not right	194	20%
Depressionlow mood	192	19.8%
Falla fall	191	19.7%
Abdominal pain upperupper stomach pain	189	19.5%
Rashskin rash	187	19.3%
Hyperhidrosisexcessive sweating	185	19.1%
Cerebrovascular accidentstroke	176	18.2%
Rhinorrhoeaa runny nose	175	18.1%
Affect lability	173	17.9%
Agitationrestlessness	173	17.9%
Bronchitischest infection	173	17.9%
Influenzaflu	173	17.9%
Muscle spasticity	173	17.9%
Sensory loss	173	17.9%
Fluid retentionthe body holding extra fluid	171	17.7%
Sinus congestion	171	17.7%
Sinus disorder	171	17.7%
Skin exfoliationpeeling skin	171	17.7%
Skin haemorrhage	171	17.7%
Sneezing	171	17.7%
Confusional stateconfusion	169	17.5%
Influenza like illnessflu-like symptoms	169	17.5%
Hallucinationseeing or hearing things that are not there	167	17.3%

Download all 313 terms of Gravol (CSV)

The counts add to more than 968 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	Generic name	1,087
Gravol (this page)	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 Gravol, 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	0	0	0	0	0	0	0	0	0
2005	0	0	0	0	0	0	0	0	0
2006	1	1	0	0	0	0	0	1	0
2007	2	2	0	1	2	0	0	1	0
2008	0	0	0	0	0	0	0	0	0
2009	1	1	0	0	0	0	0	1	0
2010	1	1	1	1	0	0	0	0	0
2011	2	2	1	1	0	0	0	1	0
2012	1	1	0	0	1	0	0	0	0
2013	6	6	2	1	3	0	1	3	0
2014	6	6	1	0	4	0	1	2	0
2015	6	6	0	1	4	0	0	5	0
2016	6	6	1	0	4	0	0	6	0
2017	11	11	1	0	4	0	0	10	0
2018	21	20	1	0	5	0	0	19	1
2019	99	99	2	3	32	1	1	91	0
2020	107	105	3	4	43	0	2	83	2
2021	99	99	1	6	27	0	1	89	0
2022	122	121	5	17	46	0	1	112	1
2023	94	93	2	12	27	0	0	83	1
2024	98	96	0	48	52	9	1	91	2
2025	176	175	0	93	88	46	0	168	1
2026	109	108	0	65	50	37	2	105	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 Gravol, 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 Gravol, by the year in which FDA received them
Year	Reports
2006	1
2007	2
2009	1
2010	2
2011	3
2012	2
2013	9
2014	10
2015	5
2016	6
2017	23
2018	29
2019	131
2020	146
2021	119
2022	126
2023	77
2024	92
2025	129
2026	55

Reports that name Gravol, 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 Gravol
Age	Reports	Share
Under 2	2	0.2%
2 to 11	0	0%
12 to 17	28	2.9%
18 to 44	230	23.8%
45 to 64	269	27.8%
65 to 74	173	17.9%
75 and over	4	0.4%
Age not given	262	27.1%

Sex of the patient in the reports that name Gravol
Sex	Reports	Share
Female	685	70.8%
Male	110	11.4%
Unknown or not given	173	17.9%

Type of reporter in the reports that name Gravol
Reporter	Reports	Share
Physician	149	15.4%
Pharmacist	16	1.7%
Other health professional	519	53.6%
Lawyer	1	0.1%
Consumer or non-health professional	277	28.6%
Not given	6	0.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 1.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Gravol record
Indication as recorded (MedDRA)	Reports	Share
Premedication	258	26.7%
Anxiety	159	16.4%
Migraine	44	4.5%
Nausea	40	4.1%
Foetal exposure during pregnancy	10	1%
Morning sickness	8	0.8%

The reporter fills in the indication, and the field is often empty. Each share is of all 968 reports.

Drugs in the same reports

Other drugs that the reports of Gravol name, in any role, in order of name
Drug	Reports that name the two
Acetaminophen	438
Aspirin	210
Cymbalta	339
Diphenhydramine hydrochloride	205
Ergocalciferol	296
Ondansetron	221
Prednisone	462
Rituximab	234
Synthroid	211
Tylenol	288

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

Dimenhydrinate same ingredient
Fexofenadine hydrochloride same class
Hydrocodone polistirex and chlorpheniramine polistirex same class
Fexofenadine hcl same class
Lastacaft same class
Fexofenadine same class
Levocetirizine dihydrochloride same class
Grastek next in the A to Z list
Grazax next in the A to Z list
Granulocyte Colony-Stimulating Factor next in the A to Z list
Grazyna Tablets 50mg next in the A to Z list
Granulocyte colony stimulating factor 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 GravolThe 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. Gravol: adverse event reports that FDA received. https://reportedreactions.com/drug/gravol/ 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 Gravol as a suspect or interacting product. The 3,924 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 Gravol 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 Gravol?

No. It is a count of what people reported to FDA: 968 reports from November 2006 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 (53.6%), consumer or non-health professional (28.6%) and physician (15.4%). 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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