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Agamree Side Effects

Generic name: vamorolone

Medically reviewed by Drugs.com. Last updated on Feb 14, 2024.

Note: This document contains side effect information about vamorolone. Some dosage forms listed on this page may not apply to the brand name Agamree.

Applies to vamorolone: oral suspension.

General

The most common adverse reactions occurring in greater than 10% of treated patients included cushingoid features, psychiatric disorders, vomiting, increased weight, and vitamin D deficiency.[Ref]

Cardiovascular

Frequency not reported: Thromboembolic events, elevated blood pressure

Endocrine

Very common (10% or more): Cushingoid features (up to 29%)

Frequency not reported: Pheochromocytoma crisis, increased blood glucose, Cushing's syndrome (hypercortisolism), acute adrenal insufficiency (after abrupt withdrawal)

Gastrointestinal

Very common (10% or more): Vomiting (up to 17%)

Common (1% to 10%): Diarrhea

Frequency not reported: Gastrointestinal perforation

Hematologic

Frequency not reported: Increased lymphocyte and neutrophil counts

Hypersensitivity

Frequency not reported: Anaphylaxis

Immunologic

Frequency not reported: Reduced resistance to new infections

Metabolic

Very common (10% or more): Increased weight (up to 11%), vitamin D deficiency (up to 11%)

Common (1% to 10%): Increased appetite

Frequency not reported: Increased excretion of potassium and calcium, salt and water retention

Musculoskeletal

Frequency not reported: Avascular necrosis, decreased bone formation, increased bone resorption

Nervous system

Common (1% to 10%): Headache

Ocular

Frequency not reported: Posterior subcapsular cataracts

Oncologic

Frequency not reported: Kaposi's sarcoma

Other

Frequency not reported: Activation of latent amebiasis, exacerbation of systemic fungal infections, hepatitis B virus reactivation

Psychiatric

Psychiatric disorders included abnormal behavior, aggression, agitation, anxiety, irritability, mood altered, sleep disorder, and stereotypy.

Very common (10% or more): Psychiatric disorders (up to 21%)

Respiratory

Very common (10% or more): Cough (up to 10%)

Common (1% to 10%): Rhinitis

References

1. Product Information. Agamree (vamorolone). Santhera Pharmaceuticals (US). 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.