Formulary
Safinamide: Indications, Dosing, Side Effects and Interactions
Safinamide is a monoamine-oxidase B inhibitor.
MedNext Academy | 3 min read
Safinamide: Indications, Dosing, Side Effects and Interactions
Safinamide is a monoamine-oxidase B inhibitor.
Drug action
Safinamide is a monoamine-oxidase B inhibitor.
Indications and dose
**Parkinson's disease, as an adjunct to levodopa alone or in combination with other antiparkinsonian drugs,**
- **Adult** (By Mouth): for mid- to late-stage fluctuations 50 mg once daily, increased if necessary to 100 mg once daily.
Cautions
Hypertension (may raise blood pressure); may exacerbate pre-existing dyskinesia (requiring levodopa dose reduction)
Contraindications
Active retinopathy; albinism; family history of hereditary retinal disease; retinal degeneration; uveitis
Side effects
Common or very common Cataract; dizziness; drowsiness; headache; hypotension; injury; nausea; sleep disorders Uncommon Anaemia; anxiety; appetite abnormal; arrhythmias; asthenia; cognitive disorder; confusion; constipation; cough; decreased leucocytes; depression; diarrhoea; dry mouth; dysarthria; dyslipidaemia; dyspnoea; emotional lability; eye disorders; eye inflammation; gastrointestinal discomfort; gastrointestinal disorders; glaucoma; hallucination; hyperglycaemia; hypertension; increased risk of infection; joint disorders; movement disorders; muscle complaints; muscle weakness; neoplasms; oral disorders; pain; palpitations; peripheral oedema; photosensitivity reaction; psychotic disorder; QT interval prolongation; red blood cell abnormality; rhinorrhoea; sensation abnormal; sensation of pressure; sexual dysfunction; skin reactions; sweat changes; syncope; temperature sensation altered; urinary disorders; varicose veins; vertigo; vision disorders; vomiting; weight changes Rare or very rare Alopecia; arterial spasm; atherosclerosis; benign prostatic hyperplasia; breast abnormalities; bronchospasm; cachexia; concentration impaired; delirium; diabetic retinopathy; dysphonia; eosinophilia; eye pain; fat embolism; fever; gambling; haemorrhage; hyperbilirubinaemia; hyperkalaemia; illusion; malaise; myocardial infarction; oropharyngeal complaints; osteoarthritis; paranoia; psychiatric disorders; pyuria; reflexes decreased; suicidal ideation; taste altered
Interactions
**Severe interactions:**
- Antidepressants The concomitant use of safinamide and fluoxetine or fluvoxamine should be avoided (see section 4.4), this precaution is based on the occurrence of serious adverse reactions (e.g.
- Serious adverse reactions have been reported with the concomitant use of selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic/tetracyclic...
- In drug-drug-interaction studies in human, a weak interaction was observed with rosuvastatin (AUC increase between 1.25 and 2.00 fold) but no significant interaction was found with diclofenac.
**Other interactions (12):**
- In view of the MAO inhibitory activity of safinamide, concomitant administration of safinamide and sympathomimetics, such as those present in nasal and oral decongestants or cold medicinal products...
- In view of the MAO inhibitory activity of safinamide, the concomitant administration of safinamide and dextromethorphan is not recommended, or if concomitant treatment is necessary, it should be...
- A washout period corresponding to 5 half-lives of the SSRI used previously should be considered prior to initiating treatment with safinamide.
- In view of the selective and reversible MAO-B inhibitory activity of safinamide, antidepressants may be administered but used at the lowest doses necessary.
- In vivo and in vitro pharmacokinetic drug interactions Safinamide may transiently inhibit BCRP in vitro .
- It is recommended to monitor patients when safinamide is taken with medicinal products that are BCRP substrates (e.g., rosuvastatin, pitavastatin, pravastatin, ciprofloxacin, methotrexate,...
Pregnancy
Manufacturer advises avoid-toxicity in animal studies.
Breast feeding
Manufacturer advises avoid-present in milk in animal studies.
Hepatic impairment
Manufacturer advises caution in moderate impairment (risk of increased exposure); avoid in severe impairment. Dose adjustments Manufacturer advises max. daily dose should not exceed 50 mg daily in moderate impairment.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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