Safinamide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Nov 19, 2024.

Applies to safinamide: oral tablet.

Serious side effects of safinamide

Along with its needed effects, safinamide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking safinamide:

More common side effects

• blurred vision
• dizziness
• headache
• nervousness
• pounding in the ears
• slow or fast heartbeat
• twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

Less common side effects

• chills
• cold sweats
• confusion
• dizziness, faintness, or lightheadedness when getting up from lying or sitting position

Incidence not known

• agitation
• confusion
• diarrhea
• feeling that others are watching you or controlling your behavior
• feeling that others can hear your thoughts
• feeling, seeing, or hearing things that are not there
• fever
• overactive reflexes
• poor coordination
• restlessness
• severe mood or mental changes
• shivering
• sweating
• talking or acting with excitement you cannot control
• trembling or shaking
• trouble breathing
• unusual behavior

Other side effects of safinamide

Some side effects of safinamide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• nausea

Less common side effects

• acid or sour stomach
• belching
• cough
• heartburn
• indigestion
• stomach discomfort, upset, or pain
• trouble sleeping

Incidence not known

• skin rash
• swelling of the gums and tongue

For healthcare professionals

Applies to safinamide: oral tablet.

General adverse events

The most commonly reported adverse events have included insomnia, dyskinesia, somnolence, nausea, orthostatic hypotension, dizziness, and headache.^[Ref]

Dermatologic

• Uncommon (0.1% to 1%): Hyperhidrosis, pruritus, photosensitivity reaction, erythema
• Rare (0.01% to 0.1%): Furuncle, pyoderma, alopecia, blister, contact dermatitis, ecchymosis, lichenoid keratosis, night sweats, skin pain, pigmentation disorder, psoriasis, seborrhoic dermatitis^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea
• Uncommon (0.1% to 1%): Constipation, dyspepsia, vomiting, dry mouth, diarrhea, abdominal pain, gastritis, flatulence, abdominal distension, salivary hypersecretion, gastroesophageal reflux disease, aphthous stomatitis
• Rare (0.01% to 0.1%): Tooth infection, peptic ulcer, retching, upper gastrointestinal hemorrhage^[Ref]

Cardiovascular

• Common (1% to 10%): Orthostatic hypotension, hypertension
• Uncommon (0.1% to 1%): Palpitations, tachycardia, sinus bradycardia, arrhythmia, hypertension, hypotension, varicose vein, QT prolongation
• Rare (0.01% to 0.1%): Myocardial infarction, arterial spasm, arteriosclerosis, hypertensive crisis, cardiac murmur, abnormal cardiac stress test^[Ref]

Genitourinary

• Uncommon (0.1% to 1%): Urinary tract infection, nocturia, dysuria, erectile dysfunction
• Rare (0.01% to 0.1%): Micturition urgency, polyuria, pyuria, urinary hesitation, benign prostatic hyperplasia, breast disorder, breast pain^[Ref]

Hematologic

• Uncommon (0.1% to 1%): Anemia, leukopenia, red blood cell abnormality
• Rare (0.01% to 0.1%): Eosinophilia, lymphopenia^[Ref]

Hepatic

• Common (1% to 10%): Elevated transaminases
• Uncommon (0.1% to 1%): Abnormal liver function tests
• Rare (0.01% to 0.1%): Hyperbilirubinemia^[Ref]

Transaminase (ALT and AST) shifts from normal to above the upper limit of normal (ULN) occurred more frequently in treated patients. During clinical trials, the percent with an ALT shift from normal to above the ULN was 5%, 7%, and 3% of patients treated with 50 mg, 100 mg, and placebo, respectively. The percent with an AST shift from normal to above the ULN was 7%, 6%, and 3% of patients treated with 50 mg, 100 mg, and placebo, respectively. No patients treated with this drug experienced an ALT increase that was 3 x ULN or higher. The incidence of patients with an increase in AST to at least 3 x ULN was similar for drug treated and placebo patients.^[Ref]

Metabolic

• Uncommon (0.1% to 1%): Decreased appetite, hypertriglyceridemia, increased appetite, hypercholesterolemia, hyperglycemia, weight increased, weight loss
• Rare (0.01% to 0.1%): Cachexia, hyperkalemia^[Ref]

Musculoskeletal

• Uncommon (0.1% to 1%): Back pain, arthralgia, muscle spasms, muscle rigidity, pain in extremity, muscular weakness, sensation of heaviness
• Rare (0.01% to 0.1%): Ankylosing spondylitis, flank pain, joint swelling, musculoskeletal pain, myalgia, neck pain, osteoarthritis, synovial cyst^[Ref]

Nervous system

• Very common (greater than 10%): Dyskinesia (up to 21%)
• Common (1% to 10%): Somnolence, dizziness, headache, Parkinson's disease
• Uncommon (0.1% to 1%): Paraesthesia, balance disorder, hypoesthesia, dystonia, head discomfort, dysarthria, syncope, cognitive disorder
• Rare (0.01% to 0.1%): Abnormal coordination, disturbance in attention, dysgeusia, hyporeflexia, radicular pain, Restless Legs Syndrome, sedation, gait disturbance
• Frequency not reported: Neuroleptic malignant syndrome, serotonin syndrome, sleep attack/sudden onset of sleep^[Ref]

During clinical trials, sleep attacks/sudden onset of sleep were reported in patients receiving 100 mg/day.

Dyskinesia was reported at 21%, 18%, and 9% during clinical trials of this drug at doses of 50 mg/day, 100 mg/day, or placebo. Dyskinesia was the most frequent cause of drug discontinuation.^[Ref]

Ocular

• Common (1% to 10%): Cataract
• Uncommon (0.1% to 1%): Vision blurred, scotoma, diplopia, photophobia, retinal disorder, conjunctivitis, glaucoma
• Rare (0.01% to 0.1%): Amblyopia, chromatopsia, diabetic retinopathy, erythropsias, eye hemorrhage, eye pain, eyelid edema, hypermetropia, keratitis, increased lacrimation, night blindness, papilledema, presbyopia, strabismus^[Ref]

Oncologic

• Uncommon (0.1% to 1%): Basal cell carcinoma
• Rare (0.01% to 0.1%): Acrochordon, melanocytic nevus, seborrhoic keratosis, skin papilloma^[Ref]

Other

• Common (1% to 10%): Fall
• Uncommon (0.1% to 1%): Vertigo, fatigue, asthenia, pain, feeling hot
• Rare (0.01% to 0.1%): Feeling cold, decreased drug effect, drug intolerance, malaise, pyrexia, xerosis^[Ref]

Psychiatric

• Common (1% to 10%): Insomnia, anxiety
• Uncommon (0.1% to 1%): Hallucination, depression, abnormal dreams, anxiety, confusional state, affect lability, libido increased, psychotic disorder, restlessness, sleep disorder
• Rare (0.01% to 0.1%): Compulsions, delirium, disorientation, illusion, impulsive behavior, loss of libido, obsessive thoughts, paranoia, premature ejaculation, sleep attacks, social phobia, suicidal ideation, gambling^[Ref]

Respiratory

• Common (1% to 10%): Cough, dyspnea
• Uncommon (0.1% to 1%): Rhinorrhea
• Rare (0.01% to 0.1%): Bronchopneumonia, nasopharyngitis, rhinitis, bronchospasm, dysphonia, oropharyngeal pain, oropharyngeal spasm^[Ref]

Hypersensitivity

Postmarketing report: Hypersensitivity reaction^[Ref]

A patient developed a hypersensitivity reaction consisting of swelling of tongue and gingiva, dyspnea, and skin rash. With discontinuation, the symptoms resolved but reappeared with a rechallenge a month later.^[Ref]

Further information

Safinamide side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer