Applies to carglumic acid: oral tablet for suspension.

Serious side effects of Carglumic acid

Along with its needed effects, carglumic acid 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 carglumic acid:

More common

• Black, tarry stools
• chills
• cough
• decreased weight
• diarrhea
• fever
• general feeling of discomfort or illness
• headache
• hoarseness
• increased sweating
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• painful or difficult urination
• pale skin
• runny nose
• shivering
• sore throat
• sweating
• trouble sleeping
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

Less common

• Agitation
• anxiety
• bloating
• blurred vision
• chest discomfort or pain
• cold sweats
• coma
• confusion
• cool, pale skin
• darkened urine
• decreased appetite
• decreased awareness or responsiveness
• depression
• dizziness
• drowsiness
• faintness
• hallucinations
• indigestion
• irritability
• mood or mental changes
• nervousness
• nightmares
• numbness, tingling, pain, or weakness in the hands or feet
• pains in the stomach, side, or abdomen, possibly radiating to the back
• seizures
• severe sleepiness
• shakiness
• slurred speech
• stiff neck
• swelling of the feet or lower legs
• trembling
• weakness and heaviness of the legs
• yellow eyes or skin

Incidence not known

• Actions that are out of control
• itching, rash
• reddened skin
• talking, feeling, and acting with excitement

Get emergency help immediately if any of the following symptoms of overdose occur while taking carglumic acid:

Symptoms of overdose

• Fast, pounding, or irregular heartbeat or pulse
• increase in mucous from the lungs
• restlessness

Other side effects of Carglumic acid

Some side effects of carglumic acid 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

• Change in hearing
• change in taste
• congestion
• ear drainage
• earache or pain in the ear
• lack or loss of strength
• loss of taste
• sleepiness or unusual drowsiness
• stomach pain
• stuffy or runny nose
• swollen glands

For Healthcare Professionals

Applies to carglumic acid: oral tablet dispersible.

General

The more commonly reported adverse reactions have included vomiting, abdominal pain, pyrexia, and infection.^[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (26%), abdominal pain (17%), tonsillitis (17%), diarrhea (13%)

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

Metabolic

Common (1% to 10%): Decreased weight, anorexia, hyperglycemia^[Ref]

Immunologic

Very common (10% or more): Infections (13%)

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

Hematologic

Very common (10% or more): Anemia (13%), decreased hemoglobin (13%)

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

Nervous system

Very common (10% or more): Headache (13%)

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

Dermatologic

Common (1% to 10%): Hyperhidrosis, rash

Postmarketing reports: Pruritus, rash including rash erythematous, rash maculopapular, rash pustular^[Ref]

Hepatic

Common (1% to 10%): Increased transaminases

Respiratory

Very common (10% or more): Nasopharyngitis (13%)

Common (1% to 10%): Pneumonia, oxygen saturation decreased

Other

Very common (10% or more): Pyrexia (17%), ear infection (13%)

Common (1% to 10%): Asthenia

Cardiovascular

Common (1% to 10%): Cardiac murmur

Uncommon (0.1% to 1%): Bradycardia

Psychiatric

Postmarketing reports: Mania