Rasagiline adverse event reports that FDA received

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

Name type: Generic name
Class: Monoamine oxidase inhibitor
Also reported as: Rasagiline 1mg 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 August 2007 to June 2026, FDA received 734 adverse event reports that name Rasagiline. In these reports the drug is a suspect or interacting product.

In the same period, 2,676 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 92 reports in the 12 months to June 2026 and 71 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, 92 (under 0.1%) name Rasagiline. Reports from consumers or other non-health professionals were 17.4% of the reports that name Rasagiline 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 Rasagiline 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 50 reports that name Rasagiline.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 15.

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 186 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 714 of the 734 reports (97.3%).

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 186 terms.

Reaction terms in the reports that name Rasagiline, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 734 reports
Drug interactionan interaction between medicines	125	17%
Serotonin syndrometoo much serotonin activity, with agitation, fever and tremor	91	12.4%
Dyskinesiainvoluntary movements	73	9.9%
Tremorshaking	49	6.7%
Drug ineffectivethe medicine did not work as expected	47	6.4%
Impulse-control disorder	39	5.3%
Confusional stateconfusion	37	5%
Condition aggravatedthe condition being treated got worse	36	4.9%
Dizzinesslight-headedness or unsteadiness	34	4.6%
Hallucinationseeing or hearing things that are not there	31	4.2%
Deliriumsudden confusion	29	4%
Off label useused for a purpose or in a way not on the label	29	4%
Parkinson's disease psychosis	29	4%
Rhabdomyolysismuscle breakdown	29	4%
Gait disturbancedifficulty walking	28	3.8%
Dystoniainvoluntary muscle contractions	26	3.5%
Agitationrestlessness	25	3.4%
On and off phenomenon	25	3.4%
Falla fall	24	3.3%
Hallucination, visual	24	3.3%
Anxiety	23	3.1%
Depressionlow mood	23	3.1%
Psychotic disordera loss of contact with reality	22	3%
Dysarthria	19	2.6%
Parkinson's disease	19	2.6%
Sedationdrowsiness	19	2.6%
Autonomic nervous system imbalance	18	2.5%
Colitis microscopic	18	2.5%
Dyspnoeashortness of breath	18	2.5%
Fatiguetiredness	18	2.5%
Cognitive disorderproblems with thinking or memory	17	2.3%
Completed suicidedeath by suicide	17	2.3%
Drug withdrawal syndromesymptoms on stopping a medicine	17	2.3%
General physical health deteriorationgeneral decline in health	17	2.3%
Hypersexuality	17	2.3%
Insomniadifficulty sleeping	17	2.3%
Suicidal ideationthoughts of suicide	17	2.3%
Toxicity to various agentspoisoning or toxic effect of one or more substances	17	2.3%
Hypertensionhigh blood pressure	16	2.2%
Orthostatic hypotension	16	2.2%
Balance disorderproblems with balance	15	2%
Cogwheel rigidity	15	2%
Somnolencedrowsiness	15	2%
Acute kidney injurysudden loss of kidney function	14	1.9%
Compulsive shopping	14	1.9%
Drug ineffective for unapproved indication	14	1.9%
Feeling abnormalfeeling odd or not right	14	1.9%
Mental disorder	14	1.9%
Muscle rigidity	14	1.9%
Pneumonialung infection	14	1.9%

Download all 186 terms of Rasagiline (CSV)

The counts add to more than 734 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 Rasagiline with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Rasagiline (this page)	Generic name	734
Rasagiline mesylate	Generic name	279
Azilect	Brand name	2,946

Sum of the separately reported names: 3,959. 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 Rasagiline, 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
2007	1	1	0	0	0	0	0	1	0
2008	2	2	0	1	2	0	0	2	0
2009	9	6	0	0	3	0	0	4	3
2010	23	23	0	2	8	0	0	17	0
2011	6	6	0	0	5	1	0	0	0
2012	12	12	0	0	7	0	0	7	0
2013	27	27	0	4	10	1	0	18	0
2014	30	30	6	3	9	0	0	19	0
2015	30	29	3	0	9	0	0	21	1
2016	18	17	0	2	14	0	0	6	1
2017	18	14	2	0	7	3	0	6	4
2018	69	62	4	4	29	0	4	41	7
2019	46	31	3	7	18	0	0	20	15
2020	61	54	1	3	27	2	0	41	7
2021	66	57	0	3	38	2	0	38	9
2022	73	67	1	4	23	2	0	54	6
2023	39	36	4	1	21	2	0	28	3
2024	56	54	9	0	25	8	0	42	2
2025	79	77	9	7	44	4	0	55	2
2026	69	67	10	16	26	8	0	53	2

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 Rasagiline, 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 Rasagiline, by the year in which FDA received them
Year	Reports
2007	1
2008	2
2009	9
2010	24
2011	6
2012	13
2013	27
2014	36
2015	27
2016	17
2017	25
2018	90
2019	39
2020	57
2021	74
2022	71
2023	26
2024	60
2025	70
2026	60

Reports that name Rasagiline, 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 Rasagiline
Age	Reports	Share
Under 2	3	0.4%
2 to 11	0	0%
12 to 17	0	0%
18 to 44	40	5.4%
45 to 64	170	23.2%
65 to 74	190	25.9%
75 and over	177	24.1%
Age not given	154	21%

Sex of the patient in the reports that name Rasagiline
Sex	Reports	Share
Female	265	36.1%
Male	396	54%
Unknown or not given	73	9.9%

Type of reporter in the reports that name Rasagiline
Reporter	Reports	Share
Physician	185	25.2%
Pharmacist	68	9.3%
Other health professional	327	44.6%
Lawyer	1	0.1%
Consumer or non-health professional	128	17.4%
Not given	25	3.4%

Age and sex are as the report gives them. The reporter is the primary source in the report. 24.1% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Rasagiline record
Indication as recorded (MedDRA)	Reports	Share
Parkinson's disease	419	57.1%
Parkinsonism	30	4.1%
Parkinson's disease	22	3%
Tremor	6	0.8%
Major depression	4	0.5%
Neuropsychological symptoms	3	0.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 734 reports.

Pages near this one

Rasagiline mesylate same ingredient
Azilect same ingredient
Phenelzine sulfate same class
Parnate same class
Selegiline same class
Nardil same class
Tranylcypromine same class
Raptiva next in the A to Z list
Rapiacta next in the A to Z list
Rasburicase next in the A to Z list
Rapamycin next in the A to Z list
Rasilez 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 RasagilineThe 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. Rasagiline: adverse event reports that FDA received. https://reportedreactions.com/drug/rasagiline/ 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 Rasagiline as a suspect or interacting product. The 2,676 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 Rasagiline 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 Rasagiline?

No. It is a count of what people reported to FDA: 734 reports from August 2007 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 (44.6%), physician (25.2%) and consumer or non-health professional (17.4%). 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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