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Xadago Side Effects

Generic name: safinamide

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 22, 2023.

Note: This document contains side effect information about safinamide. Some dosage forms listed on this page may not apply to the brand name Xadago.

Applies to safinamide: oral tablet.

Serious side effects of Xadago

Along with its needed effects, safinamide (the active ingredient contained in Xadago) 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

Less common

Incidence not known

Other side effects of Xadago

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]


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]

Frequently asked questions


1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Product Information. Xadago (safinamide). US WorldMeds LLC. 2017.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.