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Molecule

Rasagiline

Also known as rasagiline mesylate
Available on requestNeurology
Presentations
4
Brands
1
Manufacturers
1
Available from stock
0

Rasagiline is a monoamine oxidase inhibitor indicated for the treatment of Parkinson’s disease (PD). It is available as tablets for oral use. MedsAcross supplies Rasagiline for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Monoamine Oxidase Inhibitor, Monoamine Oxidase Inhibitors
ATC classification
N04BD02 Rasagiline · Dopaminergic, subgroup N04BD
US FDA first approval
16 May 2006
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Tablet
Identifiers
UNII 003N66TS6TRxCUI 134748CAS 136236-51-6DrugBank DB01367Q420685

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Rasagiline tablets are indicated for the treatment of Parkinson’s disease (PD). Rasagiline, a monoamine oxidase (MAO)-B inhibitor (MAOI), is indicated for the treatment of Parkinson’s disease

Source: US FDA prescribing information

How it works

Rasagiline is a selective, irreversible MAO-B inhibitor indicated for the treatment of idiopathic Parkinson’s disease. The results of a clinical trial designed to examine the effects of rasagiline on blood pressure when it is administered with increasing doses of tyramine indicates the functional selectivity can be incomplete when healthy subjects ingest large amounts of tyramine while receiving recommended doses of rasagiline. The selectivity for inhibiting MAO-B diminishes in a dose-related manner. MAO, a flavin-containing enzyme, is classified into two major molecular species, A and B, and is localized in mitochondrial membranes throughout the body in nerve terminals, brain, liver and intestinal mucosa. MAO regulates the metabolic degradation of catecholamines and serotonin in the CNS and peripheral tissues. MAO-B is the major form in the human brain.

Source: US FDA prescribing information

Dosing overview

Monotherapy: rasagiline 1 mg once daily. As adjunct without levodopa: rasagiline 1 mg once daily. As adjunct to levodopa: rasagiline 0.5 mg once daily. Increase dose to 1 mg daily as needed for sufficient clinical response. Patients taking ciprofloxacin or other CYP1A2 inhibitors: rasagiline 0.5 mg once daily. Patients with mild hepatic impairment: rasagiline 0.5 mg once daily. Rasagiline should not be used in patients with moderate or severe hepatic impairment

Source: US FDA prescribing information

Contraindications

Rasagiline is contraindicated for use with meperidine, tramadol, methadone, propoxyphene, and MAO inhibitors (MAOIs), including other selective MAO-B inhibitors, because of risk of serotonin syndrome. At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with these medications. Rasagiline is contraindicated for use with St. John’s wort and with cyclobenzaprine. Rasagiline is contraindicated for use with dextromethorphan because of risk of episode of psychosis or bizarre behavior. Concomitant use of meperidine, tramadol, methadone, propoxyphene dextromethorphan, St. John’s wort, cyclobenzaprine, or another (selective or non-selective) MAO inhibitor

Source: US FDA prescribing information

Warnings and precautions

May cause hypertension (including severe hypertensive syndromes) at recommended doses. May cause serotonin syndrome when used with antidepressants. May cause falling asleep during activities of daily living, daytime drowsiness, and somnolence. May cause hypotension, especially orthostatic. May cause or exacerbate dyskinesia. Decreasing the levodopa dose may lessen or eliminate this side effect. May cause hallucinations and psychotic-like behavior. May cause impulse control/compulsive behaviors. May cause withdrawal-emergent hyperpyrexia and confusion

Source: US FDA prescribing information

Side effects

The following adverse reactions are described in more detail in the Warnings and Precautions section of the label: Hypertension Serotonin Syndrome Falling Asleep During Activities of Daily Living and Somnolence Hypotension / Orthostatic Hypotension Dyskinesia Hallucinations / Psychotic-Like Behavior Impulse Control /Compulsive Behaviors Withdrawal-Emergent Hyperpyrexia and Confusion Most common adverse reactions (incidence 3% or greater than placebo): Rasagiline monotherapy: flu syndrome, arthralgia, depression, dyspepsia. Rasagiline used as adjunct without levodopa: peripheral edema, fall, arthralgia, cough, and insomnia. Rasagiline used as adjunct to levodopa: dyskinesia, accidental injury, weight loss, postural hypotension, vomiting, anorexia, arthralgia, abdominal pain, nausea, constipation, dry mouth, rash, abnormal dreams, fall, and tenosynovitis

Source: US FDA prescribing information

Interactions

Meperidine: Risk of serotonin syndrome. Dextromethorphan: Risk of psychosis or bizarre behavior. MAO inhibitors: Risk of non-selective MAO inhibition and hypertensive crisis

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

4 presentations of Rasagiline, sorted by availability.

MedicineManufacturerRegisterAvailability
Rasagiline 1 mg tabletOralGeneric name—US FDAAvailable on request
Rasagiline 0.5 mg tabletOralGeneric name—US FDAAvailable on request
Azilect 0.5 mg tabletOralTeva NeuroscienceUS FDAAvailable on request
Azilect 1 mg tabletOralTeva NeuroscienceUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 16 May 2006Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Rasagiline in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Rasagiline available for export from India?

Yes, on request. MedsAcross lists 4 presentations of Rasagiline and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Rasagiline have?

The catalogue lists 1 brand names for Rasagiline, including Azilect.

Is Rasagiline approved by the US FDA?

Yes. The US FDA first approved Rasagiline on 16 May 2006, according to Drugs@FDA.

Is Rasagiline authorised in the European Union?

Yes. Rasagiline has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Rasagiline need cold chain shipping?

No listed presentation of Rasagiline is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Rasagiline in?

Rasagiline is classified under ATC code N04BD02 (Rasagiline).

References

  1. Rasagiline prescribing information (Teva Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 30 June 2020
  2. Azilect: European public assessment report (EPAR). European Medicines Agency. Retrieved 8 April 2025
  3. Rasagiline ratiopharm: European public assessment report (EPAR). European Medicines Agency. Retrieved 9 April 2025

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