Vamorolone Side Effects

Medically reviewed by Drugs.com. Last updated on Nov 10, 2024.

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

See also:

Further information

Vamorolone 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.

Medical Disclaimer