Omidubicel Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 20, 2023.

Applies to omidubicel: intravenous suspension.

Important warnings This medicine can cause some serious health issues

Intravenous route (suspension)

Warning: Infusion Reactions, Graft versus Host Disease, Engraftment Syndrome and Graft Failure. Infusion reactions: Infusion reactions may be fatal.

Monitor patients during infusion and discontinue for severe reactions.

Use is contraindicated in patients with known allergy to dimethyl sulfoxide (DMSO), Dextran 40, gentamicin, human serum albumin, or bovine material.Graft-vs-Host Disease (GvHD): GvHD may be fatal.

Administration of immunosuppressive therapy may decrease the risk of GvHD.Engraftment syndrome: Engraftment syndrome may be fatal.

Treat engraftment syndrome promptly with corticosteroids.Graft failure: Graft failure may be fatal.

Monitor patients for laboratory evidence of hematopoietic recovery.

Serious side effects of omidubicel

Along with its needed effects, omidubicel may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking omidubicel:

More common side effects

• agitation
• black, tarry stools
• bloody nose
• bloody urine
• blue lips, fingernails, or skin
• blurred vision
• cold flu-like symptoms
• colicky or burning stomach pain
• coma
• confusion
• constipation
• cough or hoarseness
• cracked lips
• decreased urine output
• depression
• diarrhea
• difficulty in swallowing
• dizziness
• fainting
• fever or chills
• general feeling of illness
• headache
• hostility
• increase blood pressure
• increased thirst
• irritability
• lethargy
• loss of appetite
• lower back or side pain
• muscle twitching
• nausea or vomiting
• nervousness
• pain in the back of throat or chest when swallowing
• painful or difficult urination
• pounding in the ears
• seizures
• skin rash
• slow or fast heartbeat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stupor
• swelling of the face, fingers, or lower legs
• swollen glands
• trouble breathing
• unusual tiredness or weakness
• vomiting blood or material that looks like coffee grounds
• weight gain or loss
• yellow skin and eyes

Other side effects of omidubicel

Some side effects of omidubicel may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• difficulty swallowing
• pain

For healthcare professionals

Applies to omidubicel: intravenous suspension.

General adverse events

The most common adverse reactions (incidence greater than 20%) were infections, GvHD, and infusion reactions.^[Ref]

Gastrointestinal

• Very common (10% or more): Gastrointestinal toxicity (19%), dysphagia (12%)^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (25%)^[Ref]

Hematologic

• Very common (10% or more): Hemorrhage (12%)^[Ref]

Hemorrhage includes cystitis hemorrhagic, epistaxis, gastrointestinal bleeding, pulmonary alveolar hemorrhage, subarachnoid hemorrhage, and upper gastrointestinal hemorrhage.^[Ref]

Immunologic

• Very common (10% or more): Infusion reactions (any severity: 56%, Grade 3: 17% and 4: 21%), GvHD (acute up to 58%, chronic 35%)
• Common (1% to 10%): Primary graft failure^[Ref]

The most common infusion reactions were hypertension, mucosal inflammation, arrythmia, and fatigue. The most common Grade 3 to 4 infusion reaction was hypertension, reported in 6% of the patients.^[Ref]

Local

• Very common (10% or more): Pain (33%), mucosal inflammation (31%)^[Ref]

Metabolic

• Very common (10% or more): Magnesium decreased (94%), aspartate aminotransferase increased (56%), alanine aminotransferase (56%), alkaline phosphatase increased (42%), magnesium increased (15%)^[Ref]

Other

• Very common (10% or more): Viral infections (75%), bacterial infections (65%), fungal infections (21%)
• Common (1% to 10%): Fatigue, fever^[Ref]

Renal

• Very common (10% or more): Creatinine increased (50%), renal impairment (12%)^[Ref]

Respiratory

• Very common (10% or more): Respiratory failure (12%)
• Common (1% to 10%): Dyspnea (8%)^[Ref]

Respiratory failure includes acute respiratory distress syndrome, acute respiratory failure, hypoxia, and respiratory failure.^[Ref]

Hepatic

• Very common (10% or more): Bilirubin increased (42%)^[Ref]

Further information

Omidubicel 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.

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

Medical Disclaimer