Summary

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

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

• 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

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

• Nausea

Less common

• 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.

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]

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]

General

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

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]

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

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]

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]

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

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]