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
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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.