Glycopyrrolate adverse event reports that FDA received

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

Name type: Generic name
Class: Anticholinergic
Also reported as: Glycopyrrolate Injection Usp, Glycopyrrolate /00196202/, Glycopyrrolate /00196201/

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 August 2004 to June 2026, FDA received 2,225 adverse event reports that name Glycopyrrolate. In these reports the drug is a suspect or interacting product.

In the same period, 3,510 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 258 reports in the 12 months to June 2026 and 223 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, 258 (under 0.1%) name Glycopyrrolate. Reports from other health professionals were 36% of the reports that name Glycopyrrolate 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 Glycopyrrolate 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 38 reports that name Glycopyrrolate.
In January to March 2026, FDA received 52.
In April to June 2025, FDA received 58.

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 414 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 2,122 of the 2,225 reports (95.4%).

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 414 terms.

Reaction terms in the reports that name Glycopyrrolate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 2,225 reports
Dyspnoeashortness of breath	739	33.2%
Asthma	705	31.7%
Wheezing	616	27.7%
Cough	453	20.4%
Pneumonialung infection	298	13.4%
Therapeutic product effect incomplete	297	13.3%
Chronic obstructive pulmonary diseaseCOPD, a long-term lung disease	283	12.7%
Productive cougha cough with phlegm	267	12%
Chest discomfort	253	11.4%
Gastrooesophageal reflux diseaseacid reflux	253	11.4%
Obstructive airways disorder	238	10.7%
Drug ineffectivethe medicine did not work as expected	235	10.6%
Full blood count abnormal	219	9.8%
Condition aggravatedthe condition being treated got worse	215	9.7%
Malaisegeneral feeling of being unwell	215	9.7%
Bronchiectasis	214	9.6%
Loss of personal independence in daily activities	213	9.6%
Sleep disorder due to a general medical condition	213	9.6%
Product use in unapproved indicationused for a purpose not on the label	198	8.9%
Nasal congestiona blocked nose	193	8.7%
Asthma-chronic obstructive pulmonary disease overlap syndrome	184	8.3%
Nasal polyps	165	7.4%
Oedema peripheralswelling of the legs, ankles or hands	164	7.4%
Weight decreasedweight loss	160	7.2%
Rhinitis allergic	148	6.7%
Dyspnoea exertional	146	6.6%
Off label useused for a purpose or in a way not on the label	144	6.5%
Pyrexiafever	144	6.5%
Falla fall	143	6.4%
Nauseafeeling sick	138	6.2%
Total lung capacity increased	137	6.2%
Nasopharyngitisa cold	136	6.1%
Sputum discoloured	136	6.1%
Cardiac murmur	133	6%
Lung neoplasm malignantlung cancer	133	6%
Rhinorrhoeaa runny nose	133	6%
Sarcoidosis	133	6%
Lower respiratory tract infectiona chest infection	130	5.8%
Vomitingbeing sick	130	5.8%
Fatiguetiredness	127	5.7%
Upper respiratory tract infectiona cold or similar infection	118	5.3%
Tachycardiafast heart rate	109	4.9%
Influenzaflu	107	4.8%
Psychotic disordera loss of contact with reality	103	4.6%
Cholelithiasisgallstones	101	4.5%
Schizophrenia	101	4.5%
Blood bilirubin increased	100	4.5%
Hepatic enzyme increasedraised liver enzymes	100	4.5%
Hepatotoxicityliver injury	100	4.5%
Jaundice cholestatic	100	4.5%

Download all 414 terms of Glycopyrrolate (CSV)

The counts add to more than 2,225 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 Glycopyrrolate, 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	2	2	0	2	1	0	0	0	0
2005	2	1	0	0	0	0	0	1	1
2006	10	10	0	10	0	0	0	4	0
2007	2	1	0	0	1	0	0	0	1
2008	5	5	0	2	0	0	0	3	0
2009	14	13	0	0	6	0	0	12	1
2010	16	14	3	4	6	1	0	6	2
2011	3	3	0	1	1	0	0	2	0
2012	13	9	0	1	1	0	0	8	4
2013	3	1	0	0	0	0	0	1	2
2014	37	35	4	3	5	0	0	28	2
2015	42	34	16	3	3	0	0	22	8
2016	32	15	0	3	5	0	0	12	17
2017	266	249	90	11	82	4	1	148	17
2018	143	133	23	6	46	3	1	118	10
2019	137	127	20	10	47	0	0	108	10
2020	69	60	0	8	21	2	0	48	9
2021	94	86	1	3	30	1	4	74	8
2022	329	313	5	12	148	4	5	246	16
2023	256	242	3	14	122	1	2	203	14
2024	259	242	6	12	132	0	0	204	17
2025	338	313	7	24	186	0	0	259	25
2026	153	145	2	3	83	0	0	129	8

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 Glycopyrrolate, 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 Glycopyrrolate, by the year in which FDA received them
Year	Reports
2004	2
2005	2
2006	7
2007	5
2008	5
2009	14
2010	15
2011	4
2012	15
2013	3
2014	42
2015	54
2016	42
2017	301
2018	152
2019	164
2020	146
2021	204
2022	264
2023	212
2024	212
2025	270
2026	90

Reports that name Glycopyrrolate, 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 Glycopyrrolate
Age	Reports	Share
Under 2	24	1.1%
2 to 11	63	2.8%
12 to 17	23	1%
18 to 44	367	16.5%
45 to 64	536	24.1%
65 to 74	283	12.7%
75 and over	236	10.6%
Age not given	693	31.1%

Sex of the patient in the reports that name Glycopyrrolate
Sex	Reports	Share
Female	1,113	50%
Male	741	33.3%
Unknown or not given	371	16.7%

Type of reporter in the reports that name Glycopyrrolate
Reporter	Reports	Share
Physician	615	27.6%
Pharmacist	92	4.1%
Other health professional	800	36%
Lawyer	0	0%
Consumer or non-health professional	674	30.3%
Not given	44	2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.2% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Glycopyrrolate record
Indication as recorded (MedDRA)	Reports	Share
Asthma	189	8.5%
Chronic obstructive pulmonary disease	133	6%
Bradycardia	72	3.2%
Hyperhidrosis	46	2.1%
Neuromuscular blockade reversal	36	1.6%
Sinus bradycardia	36	1.6%

The reporter fills in the indication, and the field is often empty. Each share is of all 2,225 reports.

Drugs in the same reports

Other drugs that the reports of Glycopyrrolate name, in any role, in order of name
Drug	Reports that name the two
Albuterol	480
Albuterol sulfate	547
Breo Ellipta	285
Ipratropium bromide	304
Mepolizumab	268
Nucala	359
Prednisone	656
Singulair	433
Tiotropium bromide	383
Zenhale	365

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

Dicyclomine hydrochloride same class
Incruse Ellipta same class
Dicyclomine same class
Ipratropium bromide same class
Combivent Respimat same class
Ipratropium bromide and albuterol sulfate same class
Glycine Mannitol Sodium Chloride next in the A to Z list
Glycopyrronium bromide next in the A to Z list
Glyceryl Trinitrate next in the A to Z list
Glycopyrronium Indacaterol next in the A to Z list
Glycerin next in the A to Z list
Glyxambi 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 GlycopyrrolateThe 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. Glycopyrrolate: adverse event reports that FDA received. https://reportedreactions.com/drug/glycopyrrolate/ 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 Glycopyrrolate as a suspect or interacting product. The 3,510 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 Glycopyrrolate 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 Glycopyrrolate?

No. It is a count of what people reported to FDA: 2,225 reports from August 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 (36%), consumer or non-health professional (30.3%) and physician (27.6%). 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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