Prescription medication · MAO-B Inhibitor
safinamide
Also sold as Xadago. Safinamide is used to treat Parkinson's disease.
Data updated 2026-05-15
- 1,205
- FDA reportsRarely reported
- 10
- InteractionsSeveral interactions
- $36.56
- Brand price (NADAC)
What the data shows
safinamide (Xadago) is a prescription MAO-B Inhibitor, among the least-reported drugs the FDA tracks (1,205 FDA reports), with 10 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
safinamide (Xadago) is a prescription MAO-B Inhibitor. Safinamide is used to treat Parkinson's disease.
Safinamide (Xadago) is a drug used with levodopa/carbidopa to treat Parkinson's disease. It helps reduce "off" episodes, where symptoms like stiffness and slowness return.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Brand Price
$36.56/unit
Generic Available
No
MDD US
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Safinamide is used to treat Parkinson's disease.
Common side effects
Uncontrolled movements (dyskinesia), Falls, Feeling sick to your stomach (nausea)
Key warnings
Safinamide can cause or worsen high blood pressure.
The sections below are summarized in plain English from safinamide's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Safinamide is a MAO-B inhibitor. It works by blocking an enzyme in the brain that breaks down dopamine. This helps increase the amount of dopamine available, which can improve motor control.
Side Effects (from patient reports)
Based on 1,205 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for safinamide, by number of reports
- Fall
Fall
154 reports
- Hallucination
Hallucination
142 reports
- Dyskinesia
Dyskinesia
137 reports
- Gait Disturbance
Gait Disturbance
93 reports
- Death
Death
90 reports
- Parkinson^S Disease
Parkinson^S Disease
89 reports
- Tremor
Tremor
81 reports
- Fatigue
Fatigue
76 reports
- Freezing Phenomenon
Freezing Phenomenon
74 reports
- On And Off Phenomenon
On And Off Phenomenon
72 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for safinamide each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where safinamide sits
safinamide has more FDA adverse-event reports than 8% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is safinamide; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 1,205 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2016–2025.
Total Reports
1,205
Reports Mentioning Death
151
12.5% of reports — not proof of cause
Hospitalization Reports
496
Top Indication
Parkinson^S Disease
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | FALL | 154 |
| 2 | HALLUCINATION | 142 |
| 3 | DYSKINESIA | 137 |
| 4 | GAIT DISTURBANCE | 93 |
| 5 | DEATH | 90 |
| 6 | PARKINSON^S DISEASE | 89 |
| 8 | TREMOR | 81 |
| 9 | FATIGUE | 76 |
| 10 | FREEZING PHENOMENON | 74 |
| 11 | ON AND OFF PHENOMENON | 72 |
| 12 | SOMNOLENCE | 64 |
| 13 | ANXIETY | 61 |
| 14 | NAUSEA | 60 |
| 15 | DIZZINESS | 56 |
| 16 | WEIGHT DECREASED | 54 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Safinamide can cause or worsen high blood pressure. It can also cause serotonin syndrome, a dangerous condition, if taken with certain other medicines. Some people taking safinamide have fallen asleep suddenly during normal activities. Safinamide may also cause or worsen uncontrolled movements, hallucinations, and compulsive behaviors. Stopping safinamide suddenly can cause serious withdrawal symptoms.
Known Drug Interactions
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) ] .
Mechanism: Combining these drugs can cause a dangerous buildup of serotonin in the brain, which may lead to a life-threatening reaction.
Concomitant use of XADAGO with methylphenidate, amphetamine, and their derivatives is contraindicated [see Warnings and Precautions (5.1 , 5.2) ] .
Mechanism: These drugs both increase certain brain chemicals that can cause your blood pressure to rise to dangerous levels.
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).
Mechanism: Both drugs stop the body from breaking down certain chemicals, which can lead to a toxic buildup in your system.
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) ] .
Mechanism: Taking these together can cause a very serious and potentially fatal reaction in the brain and nervous system.
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) ] .
Mechanism: This combination can cause a severe, life-threatening reaction by interfering with how the brain handles certain chemicals.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
Can I take safinamide if I have liver problems?
Can I eat whatever I want while taking safinamide?
What should I do if I experience side effects?
Can I take safinamide with my other Parkinson's medications?
How long does it take for safinamide to start working?
Can safinamide cause high blood pressure?
What if I want to stop taking safinamide?
Can safinamide cause me to fall asleep suddenly?
Is safinamide a cure for Parkinson's disease?
Are there any foods I should avoid while taking safinamide?
What are the common side effects of safinamide?
Does safinamide interact with other medications?
What drug class is safinamide?
What pregnancy or breastfeeding source fields are listed for safinamide?
Related Medications in MAO-B Inhibitor
Other drugs grouped near safinamide - same-class peers and common alternatives.
acamprosate
Campral
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alprazolam
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Alprazolam (Xanax) is a medication that can help you with anxiety and panic disorders.
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amitriptyline
Elavil
Amitriptyline is a medicine used to treat depression.
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amphetamine/dextroamphetamine
Adderall, Adderall XR
Adderall XR is a stimulant medicine.
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aripiprazole
Abilify
Aripiprazole (Abilify) is a medicine used to treat certain mental disorders and mood problems.
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Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for safinamide: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 1,205.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 12.53%.
- dipyridamole Δ 0.07 pts · 3,682 reports · Antiplatelet / Vasodilator 12.47%death share
- isosorbide mononitrate Δ 0.13 pts · 19,947 reports · Nitrate Vasodilator 12.66%death share
- phenobarbital Δ 0.15 pts · 13,998 reports · Anticonvulsant (Barbiturate) 12.38%death share
- olanzapine Δ 0.16 pts · 103,356 reports · Atypical Antipsychotic 12.37%death share
Medication Guides
Understanding Drug Interactions
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Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for safinamide
The FDA label for safinamide (sold under brand names such as Xadago) classifies it as a prescription-only medication in the MAO-B Inhibitor class. Safinamide is used to treat Parkinson's disease. Official labeling lists 4 commonly reported side effects, including Uncontrolled movements (dyskinesia), Falls, Feeling sick to your stomach (nausea).
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 1,205 voluntary reports. The database also lists 10 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. NADAC pricing from CMS.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: October 22, 2025
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages