Safinamide at a glance
Medicine class
Selective, reversible monoamine oxidase-B inhibitor
Usual role
Added to stable levodopa when Parkinson’s symptoms fluctuate
Administration
Film-coated tablet swallowed with water, with or without food
Driving
Dizziness or sleepiness can impair driving and machinery use
What is Safinamide used for?
Licensed use represented by the selected products:
Add-on to stable levodopa, alone or with other Parkinson’s treatments, for adults with mid- to late-stage idiopathic Parkinson’s disease and motor fluctuations.
How does Safinamide work?
Safinamide reversibly blocks monoamine oxidase-B, reducing dopamine breakdown and increasing dopamine availability in movement-related brain areas. It also affects sodium channels and stimulated glutamate release, although these actions’ contribution to its clinical effect is uncertain.
Safinamide preparations and strengths
Tablet
Route: Oral
Strengths: 50 mg, 100 mg
How to take Safinamide
Take safinamide exactly as prescribed. Swallow the tablet with water, with or without food.
For swallowing difficulties, the tablets can be crushed and mixed with water or soft food. This is off-label, and the coating may make them taste bitter. Involve a pharmacist or Parkinson’s specialist team where possible.
Safinamide side effects
Common or expected effects
- Involuntary or excessive movements
- Difficulty sleeping
- Sleepiness
- Dizziness or headache
- Feeling faint on standing
- Nausea
- Falls
- Cataract
Get urgent medical advice
- Seek urgent assessment for severe confusion, agitation, hallucinations, fever, sweating, marked muscle stiffness, collapse or very high blood pressure.
- Promptly report new hallucinations, sudden sleep episodes, major visual changes or compulsive behaviours such as gambling, excessive spending, binge eating or increased sexual urges.
- Worsening involuntary movements may reflect increased levodopa effects and should be reviewed by the Parkinson’s team.
Safinamide in pregnancy
Human information is absent or very limited, while animal studies found reproductive toxicity. Safinamide is not recommended during pregnancy or without effective contraception if pregnancy is possible. Discuss pregnancy planning or a positive test promptly with the prescriber rather than changing treatment without advice.
Safinamide while breastfeeding
Animal evidence shows transfer into milk, and harm to a breastfed child cannot be excluded. The selected product information states that safinamide should not be used while breastfeeding; specialist advice is needed about feeding and treatment options.
Safinamide interactions
Check prescribed, pharmacy and over-the-counter medicines before combining them with safinamide.
Other monoamine oxidase inhibitors, including moclobemide
Contraindicated because excessive MAO inhibition can cause a hypertensive crisis. Switching requires prescriber management.
Pethidine
Contraindicated because serious reactions can occur with MAO inhibitors.
Common questions about Safinamide
Answers are fully visible for fast scanning and source review.
Does safinamide replace levodopa?
No. Its licensed role is as an add-on to stable levodopa.
Can safinamide cure Parkinson’s disease?
No. It helps control motor fluctuations and symptoms but does not cure the underlying condition.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.