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Carglumic Side Effects

The most commonly reported side effects of carglumic include off label use, vomiting, and ammonia increased, based on 723 FDA adverse event reports from 2007 to 2025. 3.3% of reports found the drug to be ineffective.

Carglumic side effects

Percentages show how often each reaction appears relative to total reports for carglumic.

1
Off Label Use21.2%153
2
Vomiting19.8%143
3
Ammonia Increased12.9%93
4
Hospitalisation7.2%52
5
Hyperammonaemia7.1%51
6
Death6.4%46
7
Diarrhoea6.4%46
8
Pyrexia4.1%30
9
Metabolic Disorder3.6%26
10
Drug Ineffective3.3%24
11
Condition Aggravated2.9%21
12
Seizure2.9%21
13
Constipation2.8%20
14
Nausea2.5%18
15
Pancreatitis2.5%18

These are voluntary reports and do not establish that carglumic caused these reactions.

Report severity

79.4%Serious574 reports
54.2%Hospitalizations392 reports
20.1%Fatal145 reports

Seriousness is determined by the reporter, not by OpenClaim.

Carglumic drug interactions

Other drugs that appear in adverse event reports alongside carglumic. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Glycerol-phenylbutyrate1.5%11
2
Levetiracetam1.1%8
3
Levocarnitine1.1%8
4
Cyanocobalamin1.0%7
5
Sodium-benzoate0.8%6
6
Capecitabine0.7%5
7
Cisplatin0.7%5
8
Sodium-phenylacetate0.6%4
9
Triheptanoin0.6%4
10
Valproic-acid0.6%4
11
Epirubicin-hydrochloride0.6%4
12
Rifaximin0.6%4
13
Sodium-phenylbutyrate0.4%3
14
Arginine-hydrochloride0.4%3
15
Montelukast-sodium0.4%3

Taken alongside

1
Levocarnitine22.7%164
2
Levetiracetam8.2%59
3
Sodium-benzoate6.9%50
4
Biotin6.8%49
5
Sodium-phenylbutyrate3.9%28
6
Metronidazole3.9%28
7
Ergocalciferol3.6%26
8
Arginine-hydrochloride3.5%25
9
Famotidine3.2%23
10
Omeprazole3.2%23
11
Sodium-bicarbonate2.8%20
12
Cyanocobalamin2.8%20
13
Lactulose2.8%20
14
Albuterol2.4%17
15
Aspirin2.1%15

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports carglumic side effects

33.7% of carglumic adverse event reports involve female patients and 31.5% involve male patients. The largest age group is infant at 30%. These figures reflect who reports side effects, not underlying risk.

Sex

Female33.7%
Male31.5%
Unknown34.7%

Age group

< 239.8%
2–1128.1%
12–178.6%
18–6418.8%
65+4.7%

What is carglumic used for

Conditions and purposes for which patients were taking carglumic when the adverse event was reported.

AcidosisAlkalosisAmino Acid Metabolism DisorderAmmonia AbnormalAcidosisAmino Acid Metabolism DisorderAspergillus InfectionBlood Pyruvic Acid AbnormalCarbonic Anhydrase Gene MutationCarnitine Palmitoyltransferase DeficiencyCarnitine-acylcarnitine Translocase DeficiencyCarbamoyl Phosphate Synthetase DeficiencyCarnitine Palmitoyltransferase DeficiencyEncephalopathyEnzyme Abnormality

Showing 15 of 50 indications

Carglumic brand names and reporting trend

Carglumic is sold under the brand name Carglumic Acid.

Brand names

Carglumic Acid107

Quarterly reports (20072025)

2007201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking carglumic with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.