Safinamide Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Dec 1, 2024.

Applies to safinamide: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.

Do not take safinamide if you are also using amphetamine, cyclobenzaprine, dextromethorphan (eg, Pediacare®, Robitussin®), methylphenidate (Ritalin®), St. John's wort, other MAO inhibitors (MAOI) (eg, isocarboxazid, linezolid, phenelzine, selegiline, tranylcypromine, Eldepryl®, Marplan®, Nardil®, or Parnate®), narcotic pain medicines (eg, meperidine, methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®), or medicine to treat depression (eg, amitriptyline, desvenlafaxine, duloxetine, milnacipran, nortriptyline, venlafaxine, Cymbalta®, Effexor® XR, Elavil®, Pamelor®, Pristiq®). Using these medicines together may cause serious unwanted effects.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

This medicine may make you drowsy. It may even cause you to fall asleep without warning while you drive, talk, or eat. Do not drive or do anything that could be dangerous until you know how this medicine affects you.

Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased interest in sex while using this medicine.

Do not Stop taking safinamide without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.

Avoid foods and drinks that are high in tyramine, because your blood pressure could get dangerously high. Your doctor should give you a complete list. In general, do not eat anything aged, fermented, or smoked, such as most cheese, most alcohol, cured meat (such as salami), pickled foods, sauerkraut, and soy sauce. Check the expiration dates on packages. Tyramine levels get higher as food gets older or if it has not been refrigerated properly.

Do not take other medicines unless they have been discussed with your doctor. This especially includes prescription or nonprescription (over-the-counter) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may increase your blood pressure.

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:

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:

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]

See also:

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