Safinamide is a monoamine oxidase type B inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. It is available as tablets for oral use. MedsAcross supplies Safinamide 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
From the regulator-approved product information. Each section names its source.
XADAGO is indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes. XADAGO is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease (PD) experiencing "off" episodes
Source: US FDA prescribing information
The precise mechanism by which XADAGO exerts its therapeutic effects in PD is unknown. XADAGO is an inhibitor of monoamine oxidase B (MAO-B). Inhibition of MAO-B activity, by blocking the catabolism of dopamine, is thought to result in an increase in dopamine levels and a subsequent increase in dopaminergic activity in the brain.
Source: US FDA prescribing information
Start with 50 mg administered orally once daily at the same time of day, after two weeks, the dose may be increased to 100 mg once daily, based on individual need and tolerability. Hepatic Impairment: Do not exceed 50 mg once daily in patients with moderate hepatic impairment, contraindicated in patients with severe hepatic impairment
Source: US FDA prescribing information
XADAGO is contraindicated in patients with: Concomitant use of other drugs in the monoamine oxidase inhibitor (MAOI) class or other drugs that are potent inhibitors of monoamine oxidase, including linezolid. The combination may result in increased blood pressure, including hypertensive crisis. Concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic, tetracyclic, or triazolopyridine antidepressants, cyclobenzaprine, methylphenidate, amphetamine, and their derivatives, or St John's wort. Concomitant use could result in life-threatening serotonin syndrome.
Source: US FDA prescribing information
May cause or exacerbate hypertension. May cause serotonin syndrome when used with MAO inhibitors, antidepressants, or opioid drugs. May cause falling asleep during activities of daily living. May cause or exacerbate dyskinesia, consider levodopa dose reduction. May cause hallucinations and psychotic behavior. May cause problems with impulse control/compulsive behaviors. May cause withdrawal-emergent hyperpyrexia and confusion
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of labeling: Hypertension Serotonin Syndrome Falling Asleep During Activities of Daily Living Dyskinesia Hallucinations / Psychotic Behavior Impulse Control / Compulsive Behaviors Withdrawal-Emergent Hyperpyrexia and Confusion Retinal Pathology Most common adverse reactions (incidence on XADAGO 100 mg/day at least 2% greater than placebo) were dyskinesia, fall, nausea, and insomnia
Source: US FDA prescribing information
Selective Serotonin Reuptake Inhibitors: Monitor patients for serotonin syndrome. Sympathomimetic Medications: Monitor patients for hypertension. Tyramine: Risk of severe hypertension
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted between 15°C to 30°C (59°F to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Safinamide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Xadago 100 mg tabletOral | MDD US Operations | US FDA | Available on request |
| Xadago 50 mg tabletOral | MDD US Operations | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Conditions linked to Safinamide in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Safinamide and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Safinamide, including Xadago.
Yes. The US FDA first approved Safinamide on 21 March 2017, according to Drugs@FDA.
Yes. Safinamide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Safinamide is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Safinamide is classified under ATC code N04BD03 (Safinamide).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.