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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
|Number of Patients
|Blood and lymphatic system disorders|
|Ear and labyrinth disorders|
|Ear infection||3 (13)|
|Abdominal pain||4 (17)|
|General disorders and administration site conditions|
|Infections and infestations|
|Weight decreased||2 (9)|
|Metabolism and nutrition disorders|
|Nervous system disorders|
|Skin and subcutaneous tissue disorders|
Read the Carbaglu (carglumic acid tablets) Side Effects Center for a complete guide to possible side effects
No drug interaction studies have been conductedThis monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/26/2016
Additional Carbaglu Information
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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