Generic Name: Safinamide Brand Name(s): Generics only. No brands available. Avability: Rx Pregnancy Category: C


What is Safinamide used for?

Safinamide is used with another medication (levodopa/carbidopa) to treat symptoms of Parkinson’s disease. It can help improve symptoms such as shakiness, stiffness, and difficulty moving. It can also help reduce the amount of “off” time (periods of slow movement or stiffness).

Safinamide belongs to a class of drugs known as MAO inhibitors. It works by increasing the levels of certain natural substances in the brain (such as dopamine). Parkinson’s disease is thought to be caused by too little dopamine in the brain.

How should I take Safinamide?

Take this medication by mouth with or without food as directed by your doctor, usually once daily.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

A very serious high blood pressure reaction may rarely occur if you eat a large amount of tyramine while taking safinamide and for 2 weeks after you stop it. Avoid foods that are high in tyramine, like aged cheeses (such as Stilton cheese). Consult your doctor or dietician about which foods you should avoid and if you do not feel well after eating or drinking certain foods while taking this medication. Tell your doctor if this medication stops working well or if your condition gets worse.

How do I store Safinamide?

Safinamide is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Safinamide in the bathroom or the freezer. There may be different brands of Safinamide that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Safinamide down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Safinamide?

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, high blood pressure, mental/mood disorders (such as schizophrenia, bipolar disorder, depression), eye problems (such as macular degeneration, uveitis), sleep disorders.

This drug may make you drowsy or dizzy. Alcohol or marijuana can make you more drowsy or dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Safinamide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Safinamide. Safinamide is pregnancy risk category C according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Safinamide?

Dizziness or drowsiness may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking safinamide.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: fainting, loss of balance, mental/mood changes (such as anxiety, agitation, hallucinations), worsening muscle stiffness/twitching/uncontrollable movements, unusual strong urges (such as increased gambling, increased sexual urges).

Some people taking safinamide have fallen asleep suddenly during their usual daily activities (such as talking on the phone, driving). In some cases, sleep occurred without any feelings of drowsiness beforehand. This sleep effect may occur anytime during treatment with safinamide even if you have used this medication for a long time. If you experience increased sleepiness or fall asleep during the day, do not drive or take part in other possibly dangerous activities until you have discussed this effect with your doctor. Your risk of this sleep effect is increased by using alcohol or other medications that can make you drowsy. This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take. Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.

This drug may rarely cause an attack of extremely high blood pressure (hypertensive crisis), which may be fatal. Many drug and food interactions can increase this risk. Get medical help right away if any of these serious side effects occur: severe headache, fast/slow/irregular/pounding heartbeat, chest pain, neck stiffness/soreness, severe nausea/vomiting, sweating/clammy skin (sometimes with fever), widened pupils, vision changes (such as double/blurred vision), sudden sensitivity to light (photophobia).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.


What drugs may interact with Safinamide?

Some products that may interact with this drug are: apraclonidine, bupropion, buspirone, carbamazepine, diet pills/appetite suppressants (such as diethylpropion), deutetrabenazine, dextromethorphan, methyldopa, certain supplements (such as tryptophan, tyramine), tetrabenazine, certain “triptans” used to treat migraine headaches (such as rizatriptan, sumatriptan, zolmitriptan), valbenazine.

The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/”ecstasy,” St. John’s wort, certain antidepressants (including trazodone, SSRIs such as fluoxetine/paroxetine, SNRIs such as duloxetine/venlafaxine, tricyclics such as amitriptyline/doxepin), drugs for attention deficit disorder (such as amphetamine, methylphenidate), cyclobenzaprine, certain narcotic medications (such as meperidine, methadone, propoxyphene, tramadol), among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.

Some products can interact with safinamide if you take them together, or even if you take them weeks before or after taking safinamide. Tell your doctor or pharmacist if you take anything in the list of products that may interact with this drug, or any of the products that increase serotonin, within 2 weeks before or after taking safinamide. Also tell them if you have taken fluoxetine within 5 weeks before starting safinamide. Ask your doctor how much time to wait between starting or stopping any of these drugs and starting safinamide.

Taking other MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Do not take any other MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before and after treatment with this medication. Ask your doctor when to start or stop taking this medication.

Before using safinamide, report the use of drugs that may increase the risk of extremely high blood pressure (hypertensive crisis) when combined with safinamide, including herbal products (such as ephedra/ma Huang), allergy and cough-and-cold products (including decongestants such as phenylephrine/pseudoephedrine), and stimulants (such as amphetamines, ephedrine, epinephrine, phenylalanine). Talk to your doctor or pharmacist for more details.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol), or antihistamines (such as cetirizine, diphenhydramine).

Safinamide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Safinamide?

Safinamide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Safinamide?

Safinamide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.


The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Safinamide.

What is the dose of Safinamide for an adult?

Usual Adult Dose for Parkinson’s Disease

Initial dose: 50 mg orally once a day

Maintenance dose: After 2 weeks, may increase dose to 100 mg orally once a day based on individual need and tolerability

Maximum dose: 100 mg per day


-Higher doses have not been shown to provide additional benefit while they do increase the risk for adverse reactions.

-This drug has only been shown effective in combination with levodopa/carbidopa.

Use: As adjunctive treatment to levodopa/carbidopa in patients with PD experiencing “off” episodes.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Moderate hepatic impairment (Child-Pugh B: 7 to 9): Maximum dose: 50 mg orally once a day

Severe hepatic impairment (Child-Pugh C: 10 to 15): Contraindicated

Patients who progress from moderate to severe hepatic impairment should discontinue therapy.

Dose Adjustments


-Decrease dose to 50 mg orally once a day for 1 week before stopping.

Other Comments

Administration advice:

-Take orally once a day at the same time of day

-May take with or without food

-If a dose is missed, take the next dose at the same time the next day


-Efficacy of this drug is dependent on combination use with levodopa; clinical trials have shown patients receiving this drug in combination with levodopa had longer durations of, and more beneficial “on” time as evidenced by improved motor function scores during these times.


-Monitor for new onset or worsening hypertension

-Monitor for visual changes, especially in patients with a history of retinal/macular degeneration, uveitis, inherited retinal conditions, family history of hereditary retinal disease, albinism, retinitis pigmentosa, or any active retinopathy.

-Monitor for impulse control disorders

-Monitor for dopaminergic side effects; dose adjustment of levodopa dose may be necessary

-Monitor for serotonin syndrome in patients concomitantly receiving SSRIs

Patient advice:

-Patients should be instructed to talk to their healthcare provider when considering adding any new medications including over the counter medications as there are potentially dangerous interactions; patients should be advised to avoid foods that contain large amounts of tyramine.

-Patients should be instructed to contact their healthcare provider if they experience blood pressure elevations, hallucinations, psychotic behavior, impulse control or compulsive behaviors as they may be attributed to use of this drug.

-Patients should be aware that increased dyskinesias are possible and they should contact their healthcare professional as medication adjustments may be necessary.

-Patients who are pregnant, breastfeeding, or planning to have a baby should discuss this with their doctor before taking this medication; women of childbearing potential should not be given this drug unless adequate contraception is practiced.

-Patients should be advised of the potential sedating effects of this drug; they should not drive or operate hazardous machinery until they have gained sufficient experience taking this drug.

-Patients should be advised of the possibility of falling asleep while engaged in activities of daily living (ADL), including driving; if they experience an episode of falling asleep during ADLs, they should not drive or participate in potentially dangerous activities until they have consulted with their healthcare provider.

-Patients should be advised that this drug should not be stopped abruptly.

What is the dose of Safinamide for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Safinamide available?

Safinamide is available in the following dosage forms and strengths:

  • Oral tablet.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Safinamide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.


Review Date: August 10, 2018 | Last Modified: August 10, 2018

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