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Safinamide Side Effects

In Summary

Commonly reported side effects of safinamide include: dyskinesia. Other side effects include: hypertension and increased serum alanine aminotransferase. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to safinamide: oral tablet

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
  • 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
  • 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

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 Less common Incidence not known

For Healthcare Professionals

Applies to safinamide: oral tablet


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]


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]


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]


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


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]


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

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


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]


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]


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]


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


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]


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]


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]


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]

Postmarketing report: Hypersensitivity reaction[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

2. "Product Information. Xadago (safinamide)." US WorldMeds LLC, Louisville , KY.

Some side effects of safinamide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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