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Carbaglu

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Carbaglu

Carbaglu Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Carbaglu (carglumic acid) is a man-made form of a liver enzyme used to treat hyperammonemia, a urea cycle disorder caused by lack of a certain liver enzyme. It is usually given with other medications to treat this lifelong disorder. Common side effects include vomiting, diarrhea, stomach pain, headache, stuffy nose, or sore throat.

The recommended initial dose of Carbaglu for acute hyperammonemia is 100 mg/kg/day to 250 mg/kg/day. Concomitant administration of other ammonia lowering therapies is recommended. Carbaglu may interact with other drugs. Tell your doctor all medications and supplements you use. It is unknown if Carbaglu will harm a fetus. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.

Our Carbaglu (carglumic acid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Carbaglu in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • pain or fullness in your ear, hearing problems.

Less serious side effects may include:

  • vomiting, diarrhea, stomach pain;
  • headache; or
  • stuffy nose, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Carbaglu (Carglumic Acid Tablets) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Carbaglu FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Retrospective Case Series Experience

The most common adverse reactions (occurring in ≥ 13% of patients), regardless of causality, are: Infections, vomiting, abdominal pain, pyrexia, tonsilitis, anemia, ear infection, diarrhea, nasopharyngitis, and headache.

Table 1 summarizes adverse reactions occurring in 2 or more patients treated with Carbaglu in the retrospective case series. Because these reactions were reported retrospectively, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Table 1: Adverse Reactions Reported in ≥ 2 Patients in the Retrospective Case Series treated with Carbaglu

System Organ Class Preferred Term Number of Patients
(N) (%)
TOTAL 23 (100)
Blood and lymphatic system disorders
  Anemia 3 (13)
Ear and labyrinth disorders
  Ear infection 3 (13)
Gastrointestinal disorders
  Abdominal pain 4 (17)
  Diarrhea 3 (13)
  Vomiting 6 (26)
  Dysgeusia 2 (9)
General disorders and administration site conditions
  Asthenia 2 (9)
  Hyperhidrosis 2 (9)
  Pyrexia 4 (17)
Infections and infestations
  Infection 3 (13)
  Influenza 2 (9)
  Nasopharyngitis 3 (13)
  Pneumonia 2 (9)
  Tonsillitis 4 (17)
Investigations
  Hemoglobin decreased 3 (13)
  Weight decreased 2 (9)
Metabolism and nutrition disorders
  Anorexia 2 (9)
Nervous system disorders
  Headache 3 (13)
  Somnolence 2 (9)
Skin and subcutaneous tissue disorders
  Rash 2 (9)

Read the entire FDA prescribing information for Carbaglu (Carglumic Acid Tablets) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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