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Retrospective Case Series Experience
The most common adverse reactions (occurring in ≥ 13% of patients), regardless of causality, are: 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 (carglumic acid tablets) 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 (carglumic acid tablets)
|System Organ Class Preferred Term||Number of Patients (N) (%)|
|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|
|Hemoglobin decreased||3 (13)|
|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 performed.
Last reviewed on RxList: 4/15/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Carbaglu Information
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