Wakix Side Effects
Generic name: pitolisant
Note: This document provides detailed information about Wakix Side Effects associated with pitolisant. Some dosage forms listed on this page may not apply specifically to the brand name Wakix.
Applies to pitolisant: oral tablet.
Common side effects of Wakix
Some side effects of pitolisant 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 side effects
- headache
- nausea
- trouble sleeping
Less common side effects
- anxiety
- body aches or pain
- burning, numbness, pain, or tingling in all fingers except smallest finger
- chills
- decreased appetite
- difficulty in moving
- dry mouth
- ear congestion
- fever
- headache
- loss of voice
- muscle or joint pain
- runny or stuffy nose
- seeing, hearing, or feeling things that are not there
- sneezing
- sore throat
- stomach pain or discomfort
Incidence not known
- weight gain
Serious side effects of Wakix
Along with its needed effects, pitolisant (the active ingredient contained in Wakix) 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 pitolisant:
Incidence not known
- changes in behavior
- cough
- difficulty swallowing
- discouragement
- feeling sad or empty
- dizziness
- fast or irregular heartbeat
- fainting
- hives, itching, skin rash
- irritability
- lack of appetite
- loss of interest or pleasure
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- seizures
- thoughts of killing oneself
- tightness in the chest
- trouble breathing
- trouble concentrating
- unusual tiredness or weakness
For healthcare professionals
Applies to pitolisant: oral tablet.
General adverse events
The more commonly reported adverse reactions have included insomnia, nausea, and anxiety.[Ref]
Psychiatric
- Common (1% to 10%): Insomnia, anxiety, irritability, depression, sleep disturbance, hallucinations, cataplexy
- Uncommon (0.1% to 1%): Agitation, affect lability, abnormal dreams, dyssomnia, middle insomnia, initial insomnia, terminal insomnia, nervousness, tension, apathy, nightmare, restlessness, panic attack, decreased libido, increased libido
- Rare (less than 0.1%): Abnormal behavior, confusional state, depressed mood, excitability, obsessive thoughts, dysphoria, hypnopompic hallucination, depressive symptom, hypnagogic hallucination, mental
- Postmarketing reports: Abnormal behavior, abnormal dreams, anhedonia, bipolar disorder, depression, depressed mood, nightmare, sleep disorder, suicide attempt, suicidal ideation[Ref]
Nervous system
- Common (1% to 10%): Headache, dizziness, tremor, vertigo
- Uncommon (0.1% to 1%): Dyskinesia, balance disorder, cataplexy, disturbance in attention, dystonia, on and off phenomenon, migraine, psychomotor hyperactivity, restless legs syndrome, somnolence, epilepsy, bradykinesia, paraesthesia, tinnitus
- Rare (less than 0.1%): Loss of consciousness, tension headache
- Postmarketing reports: Epilepsy[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, vomiting, dyspepsia, abdominal pain, dry mouth
- Uncommon (0.1% to 1%): Diarrhea, abdominal discomfort, upper abdominal pain, constipation, gastroesophageal reflux disease, gastritis, gastrointestinal pain, hyperacidity, oral paraesthesia, stomach discomfort
- Rare (less than 0.1%): Abdominal distention, dysphagia, flatulence, odynophagia, enterocolitis[Ref]
Other
- Common (1% to 10%): Fatigue
- Uncommon (0.1% to 1%): Asthenia, chest pain, metrorrhagia, feeling abnormal, malaise, edema, peripheral edema
- Rare (less than 0.1%): Pain, spontaneous abortion, sense of oppression, abnormal general physical condition[Ref]
Cardiovascular
- Common (1% to 10%): Increased heart rate (heart rate increased; sinus tachycardia; tachycardia)
- Uncommon (0.1% to 1%): Extrasystoles, bradycardia, hypertension, hypotension, hot flush, QTc prolongation
- Rare (less than 0.1%): ECG repolarization abnormality, ECG T-wave inversion[Ref]
At a dose of 35.6 mg/day, QTc increases of 4.2 msec were observed. With exposures 3.8-fold higher a mean QTc increase of 16 msec was observed.[Ref]
Dermatologic
- Common (1% to 10%): Rash (eczema, erythema migrans, rash, urticaria)
- Uncommon (0.1% to 1%): Sweating, erythema, pruritus, hyperhidrosis
- Rare (less than 0.1%): Toxic skin eruption, photosensitivity, night sweats[Ref]
Genitourinary
- Uncommon (0.1% to 1%): Pollakiuria[Ref]
Hepatic
- Uncommon (0.1% to 1%): Increased hepatic enzymes, increased GGT[Ref]
Metabolic
- Uncommon (0.1% to 1%): Decreased appetite, increased appetite, fluid retention, increased weight, decreased weight
- Rare (less than 0.1%): Anorexia, hyperphagia, appetite disorder[Ref]
Musculoskeletal
- Common (1% to 10%): Musculoskeletal pain ( arthralgia; back pain; carpal tunnel syndrome; limb discomfort; musculoskeletal pain; myalgia; neck pain; osteoarthritis; pain in extremity; sciatica)
- Uncommon (0.1% to 1%): Arthralgia, back pain, muscle rigidity, muscular weakness, musculoskeletal pain, myalgia, pain in extremity,
- Rare (less than 0.1%): Neck pain, musculoskeletal chest pain, increased creatine phosphokinase[Ref]
Ocular
- Uncommon (0.1% to 1%): Reduced visual acuity, blepharospasm[Ref]
Respiratory
- Common (1% to 10%): Upper respiratory tract infection (pharyngitis; rhinitis; sinusitis; upper respiratory tract infection; upper respiratory tract inflammation; viral upper respiratory tract infection)
- Uncommon (0.1% to 1%): Yawning[Ref]
References
1. Svendsen UG, Ibsen H, Rasmussen S, Leth A, Nielsen MD, Dige-Petersen H, Giese J (1986) "Effects of combined therapy with amiloride and hydrochlorothiazide on plasma and total body potassium, blood pressure, and the renin- angiotensin-aldosterone system in hypertensive patients." Eur J Clin Pharmacol, 30, p. 151-6
2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
3. (2019) "Product Information. Wakix (pitolisant)." Harmony Biosciences, LLC
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Wakix 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.