Carglumic acid

Chemical formula: C₆H₁₀N₂O₅  Molecular mass: 190.154 g/mol  PubChem compound: 121396

Pregnancy

For carglumic acid no clinical data on exposed pregnancies are available.

Animal studies have revealed minimal developmental toxicity. Caution should be exercised when prescribing to pregnant women.

Nursing mothers

Although it is not known whether carglumic acid is secreted into human milk, it has been shown to be present in the milk of lactating rats. Therefore, breast-feeding during the use of carglumic acid is contraindicated.

Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed.

Adverse reactions


Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 to 1/10), uncommon (≥1/1,000 to 1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Undesirable effects in N-acetylglutamate synthase deficiency

Investigations

Uncommon: increased transaminases

Skin and subcutaneous tissue disorders

Common: increased sweating

Not known: rash

Undesirable effects in organic acidaemia

Cardiac disorders

Uncommon: bradycardia

Gastrointestinal disorders

Uncommon: diarrhoea, vomiting

General disorders and Administration site conditions

Uncommon: pyrexia

Skin and subcutaneous tissue disorders

Not known: rash

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