Safinamide  received its initial approval for medical by FDA (Food and Drug Administration) approved Safinamide on March 21, 2017.

Safinamide is primarily used as an adjunct medication for Parkinson's disease management. It helps control symptoms like tremors and movement difficulties by increasing dopamine levels in the brain.

Safinamide is administered orally, meaning you take it by mouth and is available as 50 and 100mg tablet. The recommended dosage may be adjusted by a healthcare professional as needed.

Common side effects of Safinamide may include symptoms like nausea, insomnia, dizziness, headache, and uncontrolled movements. Serious side effects, although less common includes allergic reactions, which might present as rashes, itching, swelling, or even difficulties in breathing. Additionally, it may rarely lead to hallucinations or psychiatric symptoms, serotonin syndrome, or alterations in liver function.

Safinamide may cause an increase in blood pressure. Some individuals may experience hallucinations, confusion, or changes in mood or behavior while taking this medication.

Regular monitoring of blood pressure is recommended, especially at the start of Safinamide   or with any dosage adjustments. Promptly inform your healthcare provider if any unusual mental health changes occur.

Inform your doctor about your medications, supplements, or herbal products to avoid potential interactions. Caution is advised when using Safinamide alongside other medications that also raise serotonin levels, as it could lead to serotonin syndrome. Watch for symptoms like confusion, hallucinations, rapid heart rate, and high blood pressure. Regular blood pressure monitoring is recommended, especially at the start of treatment or with any dosage adjustments.  Inform your doctor if you notice any unusual changes in your mental health.

1. U.S FDA (Food and Drug Safety Administration), [ Last Revised 21st March 2017], [Accessed on 29th Dec 2023], https://www.fda.gov/news-events/press-announcements/fda-approves-drug-treat-parkinsons-disease
2. Baker DE, Kim AP. Formulary Drug Review: Safinamide. Hosp Pharm.[Published on 2017 September] [Accessed on 29th Dec 2023]

The drug information on this page is not a substitute for medical advice. It is meant for educational purposes only. For further details, consult your doctor about your medical condition to know if you can receive this treatment.