Agamree Side Effects
Generic name: vamorolone
Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.
Note: This document provides detailed information about Agamree.
Applies to vamorolone: oral suspension Side Effects associated with vamorolone. Some dosage forms listed on this page may not apply specifically to the brand name Agamree.
Applies to vamorolone: oral suspension.
Side effects include:
Most common adverse reactions (>10%): cushingoid features, psychiatric disorders, vomiting, increased weight, vitamin D deficiency.
For healthcare professionals
Applies to vamorolone: oral suspension.
General adverse events
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
- Very common (10% or more): Psychiatric disorders (up to 21%)
Psychiatric disorders included abnormal behavior, aggression, agitation, anxiety, irritability, mood altered, sleep disorder, and stereotypy.
Respiratory
- Very common (10% or more): Cough (up to 10%)
- Common (1% to 10%): Rhinitis
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References
1. (2023) "Product Information. Agamree (vamorolone)." Santhera Pharmaceuticals (US)
Frequently asked questions
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Further information
Agamree side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.