Applies to ganaxolone: oral suspension.

Serious side effects of Ganaxolone

Along with its needed effects, ganaxolone 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 ganaxolone:

More common

• Relaxed and calm
• sleepiness or unusual drowsiness

Incidence not known

• Changes in behavior
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• loss of interest or pleasure
• mood changes
• thoughts of killing oneself
• tiredness
• trouble concentrating
• trouble sleeping

Other side effects of Ganaxolone

Some side effects of ganaxolone 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

• Body aches or pain
• chills
• cough
• ear congestion
• fever
• headache
• increased watering of the mouth
• loss of voice
• sneezing
• sore throat
• stuffy or runny nose
• trouble breathing
• unusual weakness

Less common

• Diarrhea
• general feeling of discomfort or illness
• joint pain
• muscle aches and pains
• nausea
• shivering
• sweating
• vomiting

For Healthcare Professionals

Applies to ganaxolone: oral suspension.

Nervous system

Very common (10% or more): Somnolence (included lethargy, hypersomnia; 38%)

Common (1% to 10%): Sedation^[Ref]

Other

Very common (10% or more): Pyrexia (18%)

Common (1% to 10%): Gait disturbance^[Ref]

Respiratory

Very common (10% or more): Upper respiratory tract infection (10%)

Common (1% to 10%): Bronchitis, influenza, nasal congestion^[Ref]

Gastrointestinal

Common (1% to 10%): Salivary hypersecretion^[Ref]

Hypersensitivity

Common (1% to 10%): Seasonal allergy^[Ref]