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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)
  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


No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 8/16/2013

Side Effects

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