safinamide
Brand names: Xadago
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.
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.
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.
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.
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.
Storage
Store safinamide at room temperature, between 59°F and 86°F.
Side Effects (from patient reports)
Based on 1,022 FDA adverse event reports.
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
Death-Related Reports
151
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 |
| 7 | DRUG INEFFECTIVE | 86 |
| 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 |
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.
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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Medication Guides
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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 1,022 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.
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