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Safinamide

Safinamide is a monoamine oxidase type B (MAO-B) inhibitor used alongside levodopa/carbidopa to treat “off” episodes in people with Parkinson’s disease.

Brand name Xadago
Drug classes Breast Cancer Resistance Protein Inhibitors
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Safinamide at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Safinamide (Xadago) is a newer add-on to levodopa/carbidopa for Parkinson’s “off” episodes, the stretches when symptoms return between doses, and works by blocking MAO-B, an enzyme that breaks down dopamine; it has been on the U.S. market since about 2017 and is now available generically. Most people tolerate it fairly well, noticing mainly extra involuntary movements (dyskinesia), nausea, trouble sleeping or dizziness on standing. Its biggest risk is interactions, since dextromethorphan cough medicines, several opioids and many antidepressants can trigger dangerous reactions, so check every new medicine, cold remedies included, with your pharmacist. Report sudden sleepiness, unusual urges, hallucinations or rising blood pressure promptly.

Clinical pearls

  • Avoid very high tyramine foods such as aged cheese and pickled herring, though no special diet is needed at prescribed doses.
  • Do not stop it abruptly, because sudden stopping can cause fever, stiffness and confusion, and the higher dose is tapered over a week.
  • Decongestant sprays, drops and tablets can push blood pressure up, so check it at home if you use them.
  • Mention any retinal condition, such as retinitis pigmentosa or diabetic retinopathy, since animal studies showed retinal damage.
How we write & review this content — our editorial policy →
How you get itPrescription only
Comes asTablet
Earliest FDA record2017
Companies listing it with the FDA1
FDA label last updatedOct 22, 2025
FDA’s strongest warning (boxed)None on the label

Patient information guide A plain-language walkthrough of Safinamide, written from its FDA label.

What Safinamide is used for

▾

Safinamide is used for Parkinson’s disease in a specific situation.

  • Xadago is an add-on treatment to levodopa/carbidopa for people with Parkinson’s disease who have “off” episodes.
  • Xadago has been shown to be effective only in combination with levodopa/carbidopa.

How Safinamide works

▾

Safinamide blocks monoamine oxidase B (MAO-B), an enzyme that breaks down dopamine in the brain. This is thought to raise dopamine levels and increase dopamine activity. The exact way it helps Parkinson’s disease is not known.

Safinamide dosage

▾

Xadago is a tablet taken by mouth once a day at the same time each day, with or without food.

  • Your prescriber usually starts with a lower dose and may increase it after two weeks based on need and tolerability.
  • Doses above the recommended maximum give no added benefit and raise the risk of side effects.
  • If you miss a dose, take the next one at the usual time the next day.
  • If you take the higher dose, it is tapered down for a week before stopping.

Follow your prescriber and the label.

Dosing details from the FDA-approved label

From the Safinamide prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Parkinson's disease (adjunct to levodopa/carbidopa) - general dosing
    • Start with 50 mg orally once daily at the same time of day, without regard to meals
    • After two weeks, the dose may be increased to 100 mg once daily, based on individual need and tolerability
    • Maximum: Daily dosages above 100 mg have not been shown to provide additional benefit, and higher dosages increase the risk for adverse reactions
    • If a dose is missed, take the next dose at the same time the next day; taper 100 mg by decreasing to 50 mg for one week before stopping
  • Moderate hepatic impairment (Child-Pugh B: 7-9)
    • 50 mg orally once daily
    • Maximum: 50 mg once daily
    • Contraindicated in severe hepatic impairment (Child-Pugh C: 10-15); if a patient on 50 mg progresses from moderate to severe hepatic impairment, discontinue
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION 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 ( 2.1 ) Hepatic Impairment: Do not exceed 50 mg once daily in patients with moderate hepatic impairment; contraindicated in patients with severe hepatic impairment ( 2.2 , 4 ) 2.1 Dosing Information The recommended starting dosage of XADAGO is 50 mg administered orally once daily (at the same time of day), without regard to meals. After two weeks, the dosage may be increased to 100 mg once daily, based on individual need and tolerability. Daily dosages of XADAGO above 100 mg have not been shown to provide additional benefit, and higher dosages increase the risk for adverse reactions. XADAGO has been shown to be effective only in combination with levodopa/carbidopa [see Indications and Usage (1) ] . If a dose is missed, the next dose should be taken at the same time the next day. XADAGO 100 mg should be tapered by decreasing the dose to 50 mg for one week before stopping [see Warnings and Precautions (5.7) ] . 2.2 Dosing in Patients with Hepatic Impairment In patients with moderate hepatic impairment (Child-Pugh B: 7-9), the maximum recommended dosage of XADAGO is 50 mg orally once daily. XADAGO is contraindicated in patients with severe hepatic impairment (Child-Pugh C: 10-15) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ] . If a patient taking 50 mg XADAGO progresses from moderate to severe hepatic impairment, discontinue XADAGO.

Read the full Dosage and Administration section on DailyMed →

Safinamide side effects

▾

The most common side effects in studies were:

Common side effects

  • Dyskinesia (uncontrolled, involuntary movements)
  • Falls
  • Nausea
  • Insomnia (trouble sleeping)
  • Low blood pressure when standing up (orthostatic hypotension)
  • Anxiety
  • Cough
  • Indigestion
  • Dizziness on standing (orthostatic hypotension)

When to get medical help

  • Call your doctor if you notice new or worsening high blood pressure.
  • Get emergency help for signs of serotonin syndrome, such as agitation, hallucinations, fast heartbeat, fever, sweating, shaking, stiff muscles, seizures, nausea, vomiting or diarrhea.
  • Tell your doctor right away if you fall asleep suddenly during daily activities, such as driving, talking or eating, or feel very sleepy during the day.
  • Call your doctor if you see or hear things that aren’t there, or develop paranoid or unusual behavior.
  • Tell your doctor about new intense urges, such as gambling, sexual urges, spending money or binge eating.
  • Get medical help for swelling of the tongue or mouth, trouble breathing, or a rash.
  • Get medical help for high fever, muscle stiffness and confusion, especially after stopping Xadago or lowering the dose quickly.
  • Tell your doctor about any changes in your vision.

Contact your doctor promptly for high blood pressure, sudden sleep episodes, hallucinations, unusual urges, or signs of serotonin syndrome. Swelling of the tongue or mouth with trouble breathing needs urgent care.

Safinamide warnings and precautions

▾
  • High blood pressure: Xadago may cause or worsen it, and blood pressure should be monitored. Using more than the recommended dose raises the risk of severe spikes.
  • Serotonin syndrome: a potentially life-threatening reaction with certain antidepressants, opioids and other drugs.
  • Sudden sleepiness: some people fall asleep during activities such as driving, sometimes without warning.
  • Dyskinesia: it may cause or worsen involuntary movements. Lowering the levodopa dose may help.
  • Hallucinations and psychotic behavior: people with a major psychotic disorder should ordinarily not take it.
  • Impulse control problems: intense urges to gamble, spend, eat or have sex can occur.
  • Withdrawal problems: stopping or lowering the dose quickly may cause fever, stiffness and confusion.
  • Eye effects: retinal damage was seen in animal studies, so people with eye conditions may need vision monitoring.

Safinamide interactions

▾

Many medicines and some foods can interact with Xadago.

  • Other MAO inhibitors and linezolid: risk of hypertensive crisis. Must not be combined.
  • Opioids (tramadol, meperidine, methadone): risk of serotonin syndrome. Must not be combined.
  • SNRIs, tricyclic, tetracyclic and triazolopyridine antidepressants, cyclobenzaprine and St. John’s wort: serotonin syndrome risk. Must not be combined.
  • Methylphenidate, amphetamine and derivatives: contraindicated.
  • Dextromethorphan: reports of psychosis or abnormal behavior. Must not be combined.
  • SSRIs: use the lowest effective dose and watch for serotonin syndrome.
  • Decongestants and cold remedies: may raise blood pressure.
  • High-tyramine foods (aged cheese, pickled herring): can cause severe high blood pressure.
  • Antipsychotics and metoclopramide: may reduce effectiveness and worsen Parkinson’s symptoms.
  • Isoniazid: monitor blood pressure and food reactions.
  • At least 14 days should pass after stopping Xadago before starting certain interacting drugs, such as other MAOIs, opioids and serotonergic drugs.

Interactions listed in the FDA-approved label

From the Safinamide prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • MAO inhibitors (MAOIs) and other potent MAO inhibitors (e.g., linezolid): Co-administration increases the risk of nonselective MAO inhibition, which may lead to hypertensive crisis. Contraindicated; at least 14 days should elapse between discontinuation of XADAGO and initiation of other MAOIs.
  • Isoniazid: Isoniazid has some monoamine oxidase inhibiting activity. Monitor for hypertension and reaction to dietary tyramine in patients treated concomitantly with isoniazid and XADAGO.
  • Opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, tramadol): Serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs and MAOIs, including selective MAO-B inhibitors. Contraindicated; at least 14 days should elapse between discontinuation of XADAGO and initiation of these drugs.
  • SNRIs; triazolopyridine, tricyclic or tetracyclic antidepressants; cyclobenzaprine; St. John's wort: Concomitant use with XADAGO is contraindicated (serotonergic drugs). At least 14 days should elapse between discontinuation of XADAGO and initiation of treatment with these drugs.
  • Selective serotonin reuptake inhibitors (SSRIs): Use with XADAGO may lead to serotonin syndrome. Monitor patients for symptoms of serotonin syndrome.
  • Dextromethorphan: The combination of MAOIs and dextromethorphan has been reported to cause episodes of psychosis or bizarre behavior. Contraindicated for use with XADAGO.
  • Methylphenidate, amphetamine, and their derivatives: Hypertensive crisis has been reported in patients taking selective MAO-B inhibitors and sympathomimetic medications. Concomitant use is contraindicated.
  • Other sympathomimetic medications (including nasal, oral, or ophthalmic decongestants and cold remedies): Severe hypertensive reactions have followed administration of sympathomimetics and nonselective MAOIs. Monitor patients for hypertension.
  • Tyramine-containing foods (aged, fermented, cured, smoked, pickled foods; e.g., aged cheese, pickled herring): May cause release of norepinephrine resulting in a rise in blood pressure (Tyramine Reaction), including severe hypertension or hypertensive crisis. Avoid foods containing a large amount of tyramine while taking recommended doses of XADAGO.
  • Dopaminergic antagonists (e.g., antipsychotics, metoclopramide): May decrease the effectiveness of XADAGO and exacerbate the symptoms of PD.
Read the label’s full interactions text

7 DRUG INTERACTIONS Selective Serotonin Reuptake Inhibitors: Monitor patients for serotonin syndrome ( 7.3 ) Sympathomimetic Medications: Monitor patients for hypertension ( 7.5 ) Tyramine: Risk of severe hypertension ( 7.6 ) 7.1 MAO Inhibitors (MAOIs) XADAGO is contraindicated for use with other drugs in the MAOIs class or other drugs that are potent inhibitors of monoamine oxidase (e.g., linezolid, an oxazolidinone antibacterial, which also has reversible nonselective MAO inhibition activity). Co-administration increases the risk of nonselective MAO inhibition, which may lead to hypertensive crisis [see Contraindications (4) and Warnings and Precautions (5.1) ] . At least 14 days should elapse between discontinuation of XADAGO and initiation of treatment with other MAOIs. Isoniazid has some monoamine oxidase inhibiting activity. Monitor for hypertension and reaction to dietary tyramine in patients treated concomitantly with isoniazid and XADAGO. 7.2 Opioid Drugs Because serious, sometimes fatal reactions have been precipitated with concomitant use of opioid drugs (e.g., meperidine and its derivatives, methadone, propoxyphene, or tramadol) and MAOIs, including selective MAO-B inhibitors, concomitant use of these drugs is contraindicated [see Warnings and Precautions (5.2) ] . At least 14 days should elapse between discontinuation of XADAGO and initiation of treatment with these drugs. 7.3 Serotonergic Drugs Concomitant use of XADAGO with SNRIs; triazolopyridine, tricyclic or tetracyclic antidepressants; cyclobenzaprine (a skeletal muscle relaxant that is a tricyclic antidepressant derivative); or St. John's wort is contraindicated [see Warnings and Precautions (5.2) ] . At least 14 days should elapse between discontinuation of XADAGO and initiation of treatment with these drugs. Monitor patients for symptoms of serotonin syndrome if SSRIs are used by patients treated with XADAGO [see Warnings and Precautions (5.2) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿81 supplements and herbs with documented Safinamide interactions, ranked by severity Check Safinamide against a supplement or herb →

Before taking Safinamide

▾
  • Do not use with severe liver impairment or after an allergic reaction to safinamide.
  • With moderate liver impairment, the dose is limited to the lower dose.
  • Tell your doctor about psychotic disorders, high blood pressure or eye and retinal conditions.
  • Pregnancy: animal studies showed possible fetal harm, and human data are inadequate.
  • Breastfeeding: it is not known whether it passes into milk or affects the infant.
  • Children: safety and effectiveness have not been established.
  • Older adults: no overall differences were seen, but greater sensitivity in some cannot be ruled out.

Safinamide overdose

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There is no human experience with Xadago overdose, and no known antidote. If an overdose occurs, treatment should be stopped and supportive care given. Avoid high-tyramine foods for several weeks. Call Poison Control at 1-800-222-1222.

What Safinamide does in the body

▾

Safinamide blocks MAO-B with more than 1000-fold selectivity over MAO-A. At recommended doses it is relatively selective for MAO-B, so a tyramine-restricted diet is not required, though foods very high in tyramine should still be avoided. This selectivity decreases above the highest recommended dose. In a study in healthy people, it did not prolong the QTc interval (a heart rhythm measure) even at 3.5 times the maximum recommended dose.

How your body processes Safinamide

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Safinamide is well absorbed after swallowing, with peak levels in about 2 to 3 hours. Food slightly delays the peak but does not change how much is absorbed. Steady state is reached within 5 to 6 days.

It is cleared almost entirely by metabolism into inactive products, and most are passed in urine. Its half-life is about 20 to 26 hours. Liver impairment raises drug levels, while kidney impairment did not change them.

How to store Safinamide

▾

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

81

Supplements & herbs that interact with Safinamide

81 supplements and herbal products have documented interactions with Safinamide in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 14
  • Moderate · 56
  • Minor · 11
ACTIVATED CHARCOAL Major BEER Major BITTER ORANGE Major BREWER'S YEAST Major COWHAGE Major FEVER BARK Major LITHIUM Major RAUVOLFIA VOMITORIA Major +73 more
Every supplement checked against Safinamide — ranked by severity The full interaction hub: 14 major · 56 moderate · 11 minor · every one linked to its full report. Check Safinamide against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Safinamide: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Safinamide — the kind of thing our pharmacy team would talk through with you at the counter.

What is Xadago for?

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It is an add-on to levodopa/carbidopa for people with Parkinson’s disease who have “off” episodes, when symptoms come back between doses. It is not meant to be used on its own.

How should I take it?

▾
Take it by mouth once a day at the same time each day, with or without food. If you miss a dose, just take the next one at your usual time the next day. Don’t take extra.

Do I need to avoid certain foods?

▾
At recommended doses you don’t need a strict diet. But avoid foods very high in tyramine, such as aged cheese or pickled herring, because they could cause a dangerous rise in blood pressure.

Which medicines should I check with you before taking?

▾
Always ask first about antidepressants, opioid pain medicines like tramadol, cyclobenzaprine, stimulants, St. John’s wort, and cough medicines with dextromethorphan. Some of these must never be combined with Xadago. Also check before using decongestants or cold remedies, since they can raise blood pressure.

What side effects should I expect?

▾
The most common are dyskinesia (extra movements), falls, nausea and trouble sleeping. Call your doctor about sudden sleep episodes, hallucinations, new urges to gamble or spend, or high blood pressure.

Can I stop it suddenly?

▾
No. Stopping or cutting the dose quickly can cause fever, stiffness and confusion. If you take the higher dose, it is usually lowered for a week first, so talk with your prescriber.

Is Safinamide available over the counter?

▾
No. Safinamide is a prescription medicine: every Safinamide product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Safinamide first available?

▾
The earliest FDA record we hold for Safinamide is from 2017: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Safinamide was first used.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Safinamide on HelloPharmacist

📊Safinamide supplement interactions81 checked — ranked by severity 🌿Drug & Supplement CheckerSafinamide vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Safinamide NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Safinamide Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Safinamide forms and strengths (how it comes)

Safinamide is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Xadago
How this form is used
What it may be used for
  • Xadago is used as an add-on to levodopa/carbidopa for “off” episodes in Parkinson’s disease.
Important instructions
  • Xadago is taken by mouth once daily at the same time each day, with or without food.
  • If a Xadago dose is missed, take the next dose at the usual time the next day.
  • Xadago at the higher dose is tapered down for a week before stopping.
Available strengths 2 strengths
50 mg 100 mg
8 FDA-listed product records ⓘ

Safinamide on the U.S. market: products, makers and brands

How Safinamide appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

1 company lists 2 Safinamide product records with the FDA, mostly as tablet; the earliest marketing or approval year on record is 2017. Brand names on the directory include Xadago; the rest are generics.

1
Dose forms ⓘ
1
Labelers (makers, repackagers, distributors)
1
Brand names
2
FDA-listed product records ⓘ
2017
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (6) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

How widely Safinamide is used (Medicaid data)

A general measure of how commonly Safinamide is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Safinamide is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

26
Medicaid prescriptions filled (Q1–Q4 2025)
$32,030 gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Safinamide prescribed? Of the 1,601 medications we measure, Safinamide ranks #1,567 by Medicaid prescriptions — more than 2% of them.

Where Safinamide ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #1,567 of 1,601
#1,562 Chloramphenicol Inject... 32 Rx #1,563 Loncastuximab Tesirine... 32 Rx #1,564 Calcitonin Salmon Inje... 31 Rx #1,565 Emapalumab-lzsg Inject... 29 Rx #1,566 Elranatamab-Bcmm 27 Rx #1,567 Safinamide 26 Rx #1,568 Dalteparin Injection 26 Rx #1,569 Verteporfin Injection 25 Rx #1,570 Esomeprazole Injection 25 Rx #1,571 Vemurafenib 24 Rx #1,572 Afatinib 23 Rx

Utilization by Safinamide product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

safinamide 50 MG Oral Tablet

26 Medicaid prescriptions (Q1–Q4 2025) 100% of Safinamide prescriptions shown $32,030 gross reimbursement (before rebates) ≈ $1,232 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1922466

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Safinamide, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 3 listed Safinamide NDCs with Medicaid activity.

Compare Safinamide products

A representative set of FDA-listed product records for Safinamide — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Tablet
50 mg Oral MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA View NDC →
100 mg Oral MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. NDA View NDC →

Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Safinamide NDCs →

Safinamide recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Safinamide recalls since July 2021.

✅No Safinamide recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Safinamide RxCUI 1922448 1 dose form · 2 strengths
  1. Dose form (SCDF) Oral Tablet RxCUI 1922465 In current FDA listings
    Clinical drug / strength (SCD) 50 MG RxCUI 1922466 100 MG RxCUI 1922474

Look up RxCUI 1922448 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

💵 What Safinamide costs pharmacies (NADAC benchmark)

The national average invoice price pharmacies pay for the drug itself, from CMS's NADAC survey (data as of Sep 30, 2026). This is a supply-cost benchmark — not a retail price and not what you'd pay at the counter.

FormStrengthPharmacy acquisition benchmark
Tablet, Film Coated · Oral 50 mg $36.46 per tablet NDC details & price history
Tablet, Film Coated · Oral 100 mg $36.33 per tablet NDC details & price history
Why show this? Your out-of-pocket cost depends on insurance, pharmacy markup, and discounts — but the acquisition benchmark tells you whether the medication itself is inexpensive or costly, which strengths cost more per dose, and whether a cash-price quote is in a reasonable range. Each row links to the NDC-level record with its full price history.

Source: CMS National Average Drug Acquisition Cost (NADAC), a survey of retail pharmacy invoice prices. Benchmarks shown are the range across package sizes of a representative product for each form and strength — other manufacturers' products may differ.

Safinamide brand names

Safinamide is sold under one brand name in the FDA directory — Xadago. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Xadago

Who makes Safinamide: manufacturers and labelers

One company lists Safinamide products with the FDA. By number of product records, the largest are MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. 2

Safinamide drug class (RxNorm)

Safinamide belongs to the Monoamine Oxidase Type B Inhibitor class.

Pharmacologic class Monoamine Oxidase Type B Inhibitor
Drug family (ATC) Monoamine oxidase B inhibitors
How it works Monoamine Oxidase-B Inhibitors, Breast Cancer Resistance Protein Inhibitors

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Safinamide page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Oct 22, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Safinamide.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Safinamide after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
1
Finished products in the current FDA directory
2
Companies listing them (makers, repackagers, distributors)
1
FDA labeler codes behind them ⓘ
1
Linked representative label ⓘ
MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc.
Linked label effective
Oct 22, 2025
Composite sections available
22
Linked SPL Set ID
c4d65f28-983f-42b4-bb23-023ae0fe81b2
Linked SPL Document ID
41c1c50d-7460-15f0-e063-6294a90a1b79
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. MDD US Operations LLC, a subsidiary of Supernus Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →