Relpax (eletriptan hydrobromide) adverse event reports that FDA received

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

Name type: Brand name
Generic name: Eletriptan hydrobromide
Class: Serotonin-1b and Serotonin-1d receptor agonist

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 3,383 adverse event reports that name Relpax. In these reports the drug is a suspect or interacting product.

In the same period, 3,304 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 22 reports in the 12 months to June 2026 and 21 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, 22 (under 0.1%) name Relpax. Reports for female patients were 76.9% of the reports that name Relpax and 52.7% 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 Relpax 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 4 reports that name Relpax.
In January to March 2026, FDA received 3.
In April to June 2025, FDA received 8.

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 215 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 all 3,383 reports.

The site keeps a term for a year only if two or more reports of that year record it.

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 215 terms.

Reaction terms in the reports that name Relpax, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 3,383 reports
Drug ineffectivethe medicine did not work as expected	545	16.1%
Migraine	507	15%
Headachehead pain	390	11.5%
Malaisegeneral feeling of being unwell	171	5.1%
Nauseafeeling sick	169	5%
Vomitingbeing sick	149	4.4%
Painpain, site not specified	142	4.2%
Recalled product administered	114	3.4%
Feeling abnormalfeeling odd or not right	113	3.3%
Condition aggravatedthe condition being treated got worse	104	3.1%
Dizzinesslight-headedness or unsteadiness	104	3.1%
Off label useused for a purpose or in a way not on the label	98	2.9%
Fatiguetiredness	90	2.7%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	89	2.6%
Drug abusemisuse of a medicine	83	2.5%
Dyspnoeashortness of breath	83	2.5%
Somnolencedrowsiness	81	2.4%
Insomniadifficulty sleeping	78	2.3%
Paraesthesiatingling or pins and needles	74	2.2%
Intentional product misusedeliberate use not as intended	72	2.1%
Chest discomfort	70	2.1%
Drug dependencedependence on a medicine	68	2%
Chest pain	67	2%
Falla fall	55	1.6%
Drug interactionan interaction between medicines	52	1.5%
Product use in unapproved indicationused for a purpose not on the label	51	1.5%
Memory impairmentmemory problems	48	1.4%
Drug effect incomplete	47	1.4%
Abdominal pain upperupper stomach pain	45	1.3%
Astheniaweakness or lack of energy	44	1.3%
Anxiety	41	1.2%
Confusional stateconfusion	40	1.2%
Throat tightnessa tight throat	39	1.2%
Hypoaesthesianumbness	38	1.1%
Hypertensionhigh blood pressure	37	1.1%
Diarrhoealoose or frequent stools	36	1.1%
Nasopharyngitisa cold	36	1.1%
Neck pain	36	1.1%
Pain in extremitypain in an arm or leg	36	1.1%
Abdominal discomfortstomach discomfort	35	1%
Palpitationsawareness of the heartbeat	35	1%
Stress	35	1%
Weight increasedweight gain	35	1%
Hypersensitivityan allergic-type reaction	33	1%
Medication overuse headache	32	0.9%
Loss of consciousnesspassing out	30	0.9%
Arthralgiajoint pain	29	0.9%
Cerebrovascular accidentstroke	29	0.9%
Depressionlow mood	29	0.9%
Speech disordera speech problem	29	0.9%

Download all 215 terms of Relpax (CSV)

The counts add to more than 3,383 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 Relpax, 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	198	196	1	2	27	5	0	173	2
2005	136	133	3	4	33	5	1	110	3
2006	69	66	1	3	19	10	0	53	3
2007	99	83	1	4	23	4	0	65	16
2008	79	68	1	5	23	0	4	49	11
2009	122	46	1	1	12	2	0	37	76
2010	126	67	0	0	14	3	1	56	59
2011	95	54	0	4	14	0	2	48	41
2012	248	102	6	1	27	5	1	79	146
2013	242	91	2	1	19	9	0	69	151
2014	270	99	1	7	21	7	1	82	171
2015	295	99	2	4	35	2	1	72	196
2016	237	83	1	3	33	1	0	59	154
2017	157	67	2	1	24	5	1	49	90
2018	142	53	0	3	23	3	0	37	89
2019	337	126	1	3	41	6	0	93	211
2020	185	79	1	2	21	3	0	72	106
2021	123	63	1	1	20	5	0	47	60
2022	106	37	0	0	6	3	0	32	69
2023	41	19	0	0	8	0	0	13	22
2024	30	24	0	1	8	0	0	19	6
2025	31	25	1	0	3	0	1	22	6
2026	15	14	0	1	2	0	0	14	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 Relpax, 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 Relpax, by the year in which FDA received them
Year	Reports
2004	170
2005	160
2006	57
2007	85
2008	66
2009	16
2010	228
2011	145
2012	279
2013	259
2014	295
2015	308
2016	241
2017	161
2018	145
2019	371
2020	157
2021	79
2022	66
2023	34
2024	25
2025	29
2026	7

Reports that name Relpax, 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 Relpax
Age	Reports	Share
Under 2	11	0.3%
2 to 11	7	0.2%
12 to 17	21	0.6%
18 to 44	625	18.5%
45 to 64	955	28.2%
65 to 74	169	5%
75 and over	36	1.1%
Age not given	1,559	46.1%

Sex of the patient in the reports that name Relpax
Sex	Reports	Share
Female	2,600	76.9%
Male	441	13%
Unknown or not given	342	10.1%

Type of reporter in the reports that name Relpax
Reporter	Reports	Share
Physician	819	24.2%
Pharmacist	168	5%
Other health professional	394	11.6%
Lawyer	3	0.1%
Consumer or non-health professional	1,876	55.5%
Not given	123	3.6%

Age and sex are as the report gives them. The reporter is the primary source in the report. 75.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Relpax record
Indication as recorded (MedDRA)	Reports	Share
Migraine	1,835	54.2%
Headache	264	7.8%
Ill-defined disorder	105	3.1%
Migraine without aura	14	0.4%
Migraine with aura	11	0.3%
Cluster headache	8	0.2%

The reporter fills in the indication, and the field is often empty. Each share is of all 3,383 reports.

Drugs in the same reports

Other drugs that the reports of Relpax name, in any role, in order of name
Drug	Reports that name the two
Botox	56
Celebrex	57
Cymbalta	55
Gabapentin	50
Ibuprofen	102
Imitrex	123
Lyrica	107
Maxalt	80
Topamax	154
Topiramate	61

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

Naratriptan same class
Rizatriptan same class
Maxalt same class
Rizatriptan benzoate same class
Imitrex same class
Sumatriptan same class
Relistor next in the A to Z list
Relugolix next in the A to Z list
Relenza next in the A to Z list
Relvar Ellipta next in the A to Z list
Relafen next in the A to Z list
Relyvrio 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 RelpaxThe 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. Relpax: adverse event reports that FDA received. https://reportedreactions.com/drug/relpax/ 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 Relpax as a suspect or interacting product. The 3,304 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 Relpax 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 Relpax?

No. It is a count of what people reported to FDA: 3,383 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 (55.5%), physician (24.2%) and other health professional (11.6%). 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.

To the top of the page