Vamorolone Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 16, 2023.

Applies to vamorolone: oral suspension.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:

• fever, chills, sore throat;

• mouth sores, red or swollen gums;

• weakness, diarrhea, burning when you urinate;

• pale skin, easy bruising, unusual bleeding; or

• chest discomfort, wheezing, dry cough or hack, rapid weight loss.

Also call your doctor at once if you have:

• increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, missed menstrual periods, sexual changes;

• signs of a blood clot--chest pain, sudden cough or shortness of breath, dizziness, coughing up blood, pain, swelling, or warmth in one leg, sudden numbness or weakness (especially on one side of the body);

• signs of hepatitis reactivation--right-sided upper stomach pain, vomiting, loss of appetite, yellowing of your skin or eyes, and not feeling well;

• low blood potassium or calcium--muscle spasms, cramps or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes), constipation, irregular heartbeats, fluttering in your chest;

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• new or worsening depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself;

• any skin lesion, no matter how mild;

• muscle weakness, sudden pain or trouble moving your hip, wrist, or back;

• blurred vision, eye pain or redness, seeing halos around lights; or

• severe headache, pounding in your neck or ears, shortness of breath (even while lying down).

Vamorolone can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Your treatment may be delayed or your dose may be reduced if you have certain side effects.

Common side effects may include:

• weight gain, swelling;

• changes in mood or behavior;

• acne, increased facial or body hair growth;

• vomiting, tiredness; or

• low blood vitamin D levels.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

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

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.

Medical Disclaimer