July 1, 2016
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Carbaglu

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Carbaglu




Side Effects
Interactions

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
  Infections 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 conducted

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

Last reviewed on RxList: 1/26/2016

Side Effects
Interactions

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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