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.
How to Take It
Take safinamide once a day at the same time each day. You can take it with or without food. The starting dose is usually 50 mg daily. After two weeks, your doctor may increase it to 100 mg daily.
This is a plain-language summary of safinamide's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Safinamide may harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is not known if safinamide passes into breast milk, so talk to your doctor if you are breastfeeding.
This is a plain-language summary of safinamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take your next dose at the same time the next day. Do not take two doses at once to make up for the missed dose.
This is a plain-language summary of safinamide's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store safinamide at room temperature, between 59°F and 86°F.
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
- Seeing or hearing things that are not there
Seeing or hearing things that are not there
142 reports
- Uncontrolled movements
Uncontrolled movements
137 reports
- Trouble walking
Trouble walking
93 reports
- Death
Death
90 reports
- Parkinson's disease
Parkinson's disease
89 reports
- Shaking
Shaking
81 reports
- Tiredness
Tiredness
76 reports
- Sudden inability to move
Sudden inability to move
74 reports
- Sudden changes in symptom control
Sudden changes in symptom control
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) 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.
What to do: Do not take these two medications together.
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.
What to do: Avoid using these medications at the same time.
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.
What to do: This combination is not allowed and should be avoided.
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.
What to do: Do not use these two drugs together.
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.
What to do: Avoid taking these medications together under any circumstances.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
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?
Is safinamide safe during pregnancy?
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: October 22, 2025
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 and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
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