Carbaglu
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Carbaglu
Carbaglu Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Carbaglu in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fever, chills, body aches, flu symptoms, sores in your mouth and throat;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
- pain or fullness in your ear, hearing problems.
Less serious side effects may include:
- vomiting, diarrhea, stomach pain;
- headache; or
- stuffy nose, sore throat.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Carbaglu (Carglumic Acid Tablets) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Carbaglu FDA Prescribing Information: Side Effects
(Adverse Reactions)
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 entire FDA prescribing information for Carbaglu (Carglumic Acid Tablets) »
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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