Applies to pitolisant: oral tablet.

Serious side effects of Pitolisant

Along with its needed effects, pitolisant 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

Other side effects of Pitolisant

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

• Headache
• nausea
• trouble sleeping

Less common

• 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

For Healthcare Professionals

Applies to pitolisant: oral tablet.

General

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

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]

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]

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]