Imitrex (sumatriptan) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Sumatriptan
Class: Serotonin-1b and Serotonin-1d receptor agonist
Also reported as: Imitrex /01044801/, Imitrex Tablets, Imitrex Nasal Spray

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 January 2004 to June 2026, FDA received 7,491 adverse event reports that name Imitrex. In these reports the drug is a suspect or interacting product.

In the same period, 12,801 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 76 reports in the 12 months to June 2026 and 94 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, 76 (under 0.1%) name Imitrex. Reports from consumers or other non-health professionals were 82.9% of the reports that name Imitrex 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 Imitrex 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 13 reports that name Imitrex.
In January to March 2026, FDA received 16.
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 339 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 7,485 of the 7,491 reports (99.9%).

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 339 terms.

Reaction terms in the reports that name Imitrex, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 7,491 reports
Drug ineffectivethe medicine did not work as expected	2,645	35.3%
Nauseafeeling sick	548	7.3%
Headachehead pain	546	7.3%
Migraine	540	7.2%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	538	7.2%
Pharmaceutical product complaint	453	6%
Vomitingbeing sick	362	4.8%
Product quality issuea problem with the product itself	342	4.6%
Chest discomfort	247	3.3%
Dizzinesslight-headedness or unsteadiness	235	3.1%
Chest pain	227	3%
Dyspnoeashortness of breath	211	2.8%
Painpain, site not specified	211	2.8%
Feeling abnormalfeeling odd or not right	206	2.7%
Malaisegeneral feeling of being unwell	203	2.7%
Injection site painpain where the injection was given	201	2.7%
Drug administration errora mistake in giving the medicine	171	2.3%
Somnolencedrowsiness	170	2.3%
Therapeutic response decreasedthe medicine worked less well	157	2.1%
Palpitationsawareness of the heartbeat	140	1.9%
Hypoaesthesianumbness	135	1.8%
Fatiguetiredness	134	1.8%
Hypersensitivityan allergic-type reaction	129	1.7%
Paraesthesiatingling or pins and needles	128	1.7%
Blood pressure increaseda raised blood pressure reading	114	1.5%
Myocardial infarctionheart attack	113	1.5%
Overdosea dose above the recommended amount	108	1.4%
Rashskin rash	97	1.3%
Throat tightnessa tight throat	97	1.3%
Anxiety	96	1.3%
Burning sensationa burning feeling	93	1.2%
Flushingsudden reddening or warmth of the skin	92	1.2%
Urticariahives	91	1.2%
Tremorshaking	87	1.2%
Adverse eventan unwanted medical event, type not specified	83	1.1%
Diarrhoealoose or frequent stools	83	1.1%
Muscle tightness	83	1.1%
Incorrect route of drug administrationthe medicine was given by the wrong route	82	1.1%
Feeling hot	78	1%
Hyperhidrosisexcessive sweating	78	1%
Dysgeusiaaltered taste	77	1%
Memory impairmentmemory problems	76	1%
Arthralgiajoint pain	75	1%
Astheniaweakness or lack of energy	75	1%
Pain in extremitypain in an arm or leg	75	1%
Heart rate increaseda fast heart rate reading	74	1%
Cerebrovascular accidentstroke	73	1%
Hypertensionhigh blood pressure	70	0.9%
Drug interactionan interaction between medicines	68	0.9%
Ill-defined disordera condition that was not clearly described	64	0.9%

Download all 339 terms of Imitrex (CSV)

The counts add to more than 7,491 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 Sumatriptan with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Sumatriptan	Generic name	6,690
Sumatriptan succinate	Generic name	3,580
Imitrex (this page)	Brand name	7,491

Sum of the separately reported names: 17,761. 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 Imitrex, 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	1,010	136	8	18	54	7	6	85	874
2005	673	141	4	16	55	15	3	86	532
2006	582	118	7	9	46	6	1	71	464
2007	628	124	5	12	43	14	0	73	504
2008	600	115	5	9	40	11	1	64	485
2009	422	87	3	12	36	7	0	53	335
2010	303	77	4	7	21	12	1	55	226
2011	202	62	9	2	23	2	0	33	140
2012	114	50	0	3	15	5	0	36	64
2013	246	53	2	5	25	1	4	31	193
2014	289	83	3	3	46	6	7	45	206
2015	489	116	3	5	48	3	2	96	373
2016	356	79	2	4	34	4	0	68	277
2017	207	46	0	1	20	0	0	38	161
2018	177	53	6	1	23	5	0	43	124
2019	292	40	4	0	11	3	0	32	252
2020	176	45	1	0	10	0	0	40	131
2021	165	33	2	0	10	0	0	29	132
2022	164	52	0	2	8	1	1	44	112
2023	141	33	1	0	4	2	1	29	108
2024	113	32	0	1	5	1	2	29	81
2025	106	39	0	0	14	2	0	32	67
2026	36	14	0	4	7	0	0	13	22

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 Imitrex, 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 Imitrex, by the year in which FDA received them
Year	Reports
2004	263
2005	1,010
2006	626
2007	640
2008	583
2009	569
2010	353
2011	274
2012	250
2013	261
2014	315
2015	475
2016	341
2017	195
2018	177
2019	286
2020	172
2021	165
2022	156
2023	146
2024	112
2025	93
2026	29

Reports that name Imitrex, 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 Imitrex
Age	Reports	Share
Under 2	16	0.2%
2 to 11	15	0.2%
12 to 17	64	0.9%
18 to 44	1,194	15.9%
45 to 64	1,655	22.1%
65 to 74	232	3.1%
75 and over	56	0.7%
Age not given	4,259	56.9%

Sex of the patient in the reports that name Imitrex
Sex	Reports	Share
Female	5,581	74.5%
Male	1,049	14%
Unknown or not given	861	11.5%

Type of reporter in the reports that name Imitrex
Reporter	Reports	Share
Physician	446	6%
Pharmacist	142	1.9%
Other health professional	536	7.2%
Lawyer	12	0.2%
Consumer or non-health professional	6,213	82.9%
Not given	142	1.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 91.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Imitrex record
Indication as recorded (MedDRA)	Reports	Share
Migraine	4,486	59.9%
Headache	248	3.3%
Cluster headache	77	1%
Ill-defined disorder	20	0.3%
Migraine prophylaxis	7	0.1%
Psoriasis	7	0.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 7,491 reports.

Drugs in the same reports

Other drugs that the reports of Imitrex name, in any role, in order of name
Drug	Reports that name the two
Aspirin	127
Cymbalta	118
Gabapentin	107
Ibuprofen	124
Maxalt	123
Relpax	148
Sumatriptan succinate	169
Synthroid	145
Topamax	356
Tylenol	109

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

Sumatriptan same ingredient
Sumatriptan succinate same ingredient
Eletriptan hbr same class
Maxalt same class
Almotriptan malate same class
Naratriptan same class
Almotriptan same class
Relpax same class
Imiquimod next in the A to Z list
Imjudo next in the A to Z list
Imipramine hydrochloride next in the A to Z list
Imlygic 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 ImitrexThe 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. Imitrex: adverse event reports that FDA received. https://reportedreactions.com/drug/imitrex/ 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 Imitrex as a suspect or interacting product. The 12,801 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 Imitrex 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 Imitrex?

No. It is a count of what people reported to FDA: 7,491 reports from January 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 (82.9%), other health professional (7.2%) and physician (6%). 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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