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Carbaglu

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Carbaglu

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SIDE EFFECTS

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) (%)
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 Carbaglu (carglumic acid tablets) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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.

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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