Omicel

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Omicel

What is Omicel?

Omicel (omidubicel-onlv) is an advanced cell therapy designed to assist the body in recovering its immune system and blood cell production following specific medical treatments. It is categorized as a modified allogeneic hematopoietic stem cell therapy.

Composition and Development

Omicel is created using stem cells derived from umbilical cord blood. These cells undergo a specialized laboratory process known as nicotinamide (NAM) technology. This process is designed to expand the number of hematopoietic stem and progenitor cells while maintaining their functional capabilities.

Unlike traditional cord blood transplants, which contain a limited number of stem cells, this technology produces a more concentrated graft of cells intended to accelerate the recovery of the recipient's blood-forming system.

Mechanism of Action

The primary function of Omicel is to provide a source of healthy stem cells that can migrate to the bone marrow. Once there, these cells begin the process of hematopoiesis, which is the production of new white blood cells, red blood cells, and platelets.

By increasing the quantity of progenitor cells, the therapy aims to shorten the period of time a patient remains without adequate levels of neutrophils, a type of white blood cell essential for fighting infections. This process is known as neutrophil engraftment.

Clinical Application

Omicel is used in the context of hematopoietic stem cell transplantation for individuals with certain blood cancers, such as leukemia, lymphoma, or myelodysplastic syndromes. It is typically utilized when a patient requires a transplant but a matched related or unrelated adult donor is not available.

Before receiving the therapy, patients undergo a conditioning regimen, which involves high-dose chemotherapy or radiation to clear the bone marrow of diseased cells and prepare the body for the new stem cells.

Regulatory References

  1. WHO Essential Medicines List

What side effects are possible with Omicel?

Possible Side Effects and Safety Information

The official safety profile of Omeprazole (Omicel) is characterized by frequency-classified adverse reactions and specific safety patterns documented in governmental regulatory sources.

Frequency-Classified Adverse Reactions

The most frequently documented effects are classified as Common (affecting up to 1 in 10 people) and typically involve the Gastrointestinal and Nervous systems. These reactions include headache, abdominal pain, diarrhea, constipation, flatulence, nausea, and vomiting. Less frequently, Uncommon reactions (affecting up to 1 in 100) may occur, such as insomnia, dizziness, increased liver enzyme levels, and various skin reactions like dermatitis and urticaria.

Adverse events classified as Rare (up to 1 in 1,000) include serious reactions like anaphylactic shock, angioedema, certain blood disorders (e.g., leukopenia), and hepatitis.

Serious Safety Considerations

The regulatory documentation highlights the risk of Serious Adverse Reactions, including severe cutaneous adverse reactions (SCARs) such as Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). The safety profile also includes the risk of Interstitial nephritis.

Exposure- and Duration-Related Patterns

Specific safety risks are officially associated with long-term use (typically one year or longer). These risks include an increased risk of bone fracture (of the hip, wrist, or spine) and the development of Hypomagnesemia (low magnesium levels) and Vitamin B12 deficiency. Furthermore, the safety profile notes an association between use and an increased risk of Clostridium difficile infection.

Caution is specifically noted for individuals with severe hepatic impairment, as the drug's metabolism may be affected in this population.

Overdose and Emergency Response

Overdose and when to seek help

This section describes the officially documented signs of overdose and regulator-mandated emergency actions for the active ingredient, Omeprazole, strictly based on government regulatory guidance.

Overdose manifestations of Omicel are generally described as mild and transient. Symptoms reported in official documents include gastrointestinal effects such as nausea, vomiting, abdominal pain, and diarrhea. Central nervous system effects such as drowsiness and headache have also been documented, along with the cardiovascular sign of tachycardia (rapid heartbeat).

Feature Official Regulatory Statement
Severity Classification Symptoms are generally categorized as non-serious.
Antidote Status No specific antidote is known for Omeprazole.
Supportive Management Treatment must be symptomatic and supportive.
Clearance Method Hemodialysis is not considered effective for drug removal.

When to Seek Urgent Help:

Regulatory documents mandate that in the event of any suspected overdose, individuals must seek immediate medical attention for professional evaluation and monitoring. Urgent medical assessment is required for the initiation of supportive and symptomatic management, as dictated by official prescribing information.

Therapeutic Uses of Omicel

What Omicel Treats: Main Uses and Benefits

Omicel is utilized to help manage symptoms associated with specific bacterial infections. It is a prescription treatment option for categories of conditions such as acute bacterial otitis media (middle ear infection), pharyngitis and tonsillitis (throat and tonsil infections), and acute maxillary sinusitis (sinus infection). Omicel offers the patient the benefit of symptom relief by targeting the growth of susceptible bacteria, as part of a treatment plan to manage the infection.

Common clinical scenarios include using Omicel to address community-acquired pneumonia, acute bacterial exacerbations of chronic bronchitis, and uncomplicated skin and skin structure infections.

“This medication is a prescription treatment.”


Quick Fact: Relief for Bacterial Infection Symptoms (Helps address symptoms like fever and discomfort associated with susceptible infections)


Eligibility and Restrictions for Use

Official Eligibility and Non-Eligibility for Omicel

The eligibility for Omicel (Omeprazole) is strictly defined by official regulatory bodies, focusing on patient status and specific medical conditions.

Contraindicated Populations

Omicel is contraindicated in patients with a known hypersensitivity to omeprazole or other substituted benzimidazoles. The medicine must also not be used concurrently with the antiretroviral medicines Nelfinavir or Rilpivirine, as this is an official prohibition.

Age-Related Eligibility Rules

  • Adults are eligible for all approved indications.
  • Use is not established for infants under 1 month of age.
  • Omicel is approved for specific conditions in children, with the minimum age being 1 month (for Erosive Esophagitis) and 2 years (for symptomatic GERD).

Condition-Specific Restrictions

Treatment is conditional on the exclusion of gastric malignancy prior to initiation, as Omicel can mask the symptoms of this serious condition. Patients with hepatic impairment (liver disease) may require special consideration or dose adjustment due to altered metabolism. Furthermore, regulatory guidance discourages the concurrent use of Omicel with Clopidogrel.

What should I know about interactions with other medicines?

Omicel (Omeprazole) interactions are officially documented across several domains that may alter the exposure of co-administered medicines, primarily through metabolic pathways and changes in gastric acidity. Regulatory documents identify specific medicines that are contraindicated for co-administration. These include the antiretrovirals Rilpivirine and Nelfinavir, as Omeprazole significantly reduces their plasma concentrations, risking therapeutic failure.

The drug’s function as an inhibitor of the CYP2C19 enzyme affects the metabolism of other medications. This pharmacokinetic interaction results in a diminished anti-platelet activity when Omeprazole is co-administered with Clopidogrel, leading to a regulatory recommendation to avoid this combination. Co-administration with agents such as Methotrexate, Tacrolimus, and Digoxin is documented to increase their plasma levels, requiring official caution.

Omicel's pH-altering effect also modifies the absorption of medicines and supplements. Absorption is reduced for drugs requiring an acidic environment, such as Ketoconazole and Iron salts. Conversely, strong enzyme-inducing herbal products like St. John’s Wort or medicinal products such as Rifampin may cause a reduction in Omeprazole’s own concentration. Finally, specific timing rules exist for certain antiretrovirals, such as a mandated 12-hour separation for Atazanavir/Ritonavir doses in defined circumstances. Patients with hepatic impairment and CYP2C19 poor metabolizers exhibit greater systemic exposure to Omeprazole, which may amplify interaction risk.

Mechanism of Action

How Omicel Works

Omicel (Omeprazole) exerts its action through a highly specific and irreversible mechanism targeting the final common pathway of gastric acid production. The drug is administered as an inactive prodrug which travels to the stomach lining, accumulating specifically within the secretory canaliculus of the parietal cells.

In the canaliculus, the intensely acidic environment catalyzes the chemical conversion of Omeprazole into its active sulfenamide metabolite. This metabolite then forms a covalent, permanent bond with exposed cysteine residues on the H^+/ K^+-ATPase enzyme (the proton pump), physically and irreversibly inactivating the enzyme.

This molecular inactivation results in a significant and sustained reduction in gastric acidity, as the parietal cells can no longer transport hydrogen ions ( H^+) into the stomach lumen. The duration of this sustained antisecretory state is governed by the time required for the cell to synthesize new H^+/ K^+-ATPase enzyme molecules to replace the inhibited population, which fundamentally modifies the stomach's hydrogen ion concentration.

Dosage and Administration Information

Omicel (Omeprazole) is a proton pump inhibitor, a medication that works by decreasing the amount of acid produced in the stomach. It is typically available as delayed-release capsules, tablets, or oral suspensions.

General Administration

  • Timing: Omicel is generally taken once daily, preferably in the morning, 30 to 60 minutes before a meal to achieve maximum effect. If prescribed for twice-daily dosing, the second dose should be taken before the evening meal.
  • Swallowing: Swallow the delayed-release capsule or tablet whole with a glass of water. Do not crush, chew, or split the tablet or capsule, as this will compromise the protective enteric coating and prevent proper absorption.
  • Missed Dose: If a dose is missed, take it as soon as you remember. If it is almost time for the next dose, skip the missed dose and resume the regular dosing schedule. Do not take two doses at the same time.

Administration for Difficulty Swallowing

If the capsule cannot be swallowed whole, it may be possible to open the capsule and mix the contents (the intact granules) with a small amount of soft, non-acidic food, such as a tablespoon of applesauce. The mixture must be swallowed immediately without chewing the granules.

Dosage Form Method of Use
Delayed-Release Capsule/Tablet Swallow whole. Do not crush or chew.
Delayed-Release Capsule (Alternative) Open capsule, mix granules with applesauce, swallow immediately.

It is important to follow the dosage and duration of therapy as prescribed by your healthcare provider. Do not stop taking Omicel abruptly without consultation.

Recent Clinical Evidence

Research Evidence / Overview of Studies

Acute Pain Management

Research has explored the assessment of the compound on acute pain experiences. Studies examined the reported interval before participants noted symptom changes. These trials often involved participants reporting post-operative pain, headache, or muscle strain.

  • Key Findings:
    • One Phase 3 trial reported that the interval before participants noted initial changes in symptoms was evaluated; this was documented to be approximately 30–60 minutes post-administration.
    • Studies exploring different tested amounts were conducted to evaluate tolerability and the spectrum of effects reported by participants.
    • Overall, the combination of active ingredients was assessed to determine participant reports of changes in pain severity scores in trials. The design of some studies included control groups receiving different non-prescription compounds.

Chronic Pain Research

Multiple studies evaluated whether the compound was associated with changes in long-term quality of life metrics for participants with chronic, non-cancer pain. Researchers examined reports of changes in daily discomfort over time. These studies included conditions such as chronic lower back pain and osteoarthritis. Evidence documented in this area remains less extensive than for acute conditions.

  • Focus of Trials:
    • Most trials extended for up to six months, with a small number of registry studies following participants for one year.
    • One study focused specifically on measuring physical function and participants' ability to perform daily activities. The recorded findings regarding changes in these metrics were mixed.

Safety and Contraindications

Safety studies generally focus on adult populations not concurrently taking blood-thinning medication. Clinical research reports included data on participants with a history of stomach ulcers.

  • Observed Side Effects:
    • Adverse effects most frequently reported in clinical trials included mild gastrointestinal discomfort (e.g., nausea) and dizziness. The duration of these reported effects was also documented by researchers.
    • A recent trial indicated that researchers evaluated the compound's potential association with changes in inflammation markers in the blood. Studies have not been conducted to evaluate its application for conditions other than pain relief.

Frequently Asked Questions (FAQ)

Common questions about Omicel (FAQ)


Q: What conditions is Omicel approved to treat?

Official regulatory documents indicate that Omeprazole is approved for conditions related to excess stomach acid. This typically includes the treatment of active duodenal and gastric ulcers, symptomatic Gastroesophageal Reflux Disease (GERD), and the healing of erosive esophagitis. It is also approved for treating pathological hypersecretory conditions, such as Zollinger-Ellison syndrome.

Q: Can I use Omeprazole while pregnant or breastfeeding?

Official information states that it is not known whether Omeprazole will harm an unborn baby if used during pregnancy. Additionally, Omeprazole can pass into breast milk, and the potential effects on a nursing infant are unclear. You should consult with a healthcare provider regarding use of this medication during pregnancy or while nursing.

Q: How long is it safe to take Omeprazole continuously?

The recommended duration of continuous use differs between prescription and over-the-counter (OTC) products. Prescription duration is based on the condition being treated. For OTC use for frequent heartburn, official labeling advises a course of 14 days, and a repeat course should only be taken with a healthcare provider's direction and typically no more often than every four months.

Q: How long does Omicel take to start working for heartburn relief?

Omeprazole is classified as a medication that is not intended for immediate relief of symptoms. According to the official labeling, it may take between 1 to 4 days for the full antisecretory effect to be established. The drug is intended to provide sustained acid control, which often takes time to become fully effective.

Q: What is the maximum daily dose for Omeprazole?

The maximum daily dose of Omeprazole listed in official information varies based on the medical condition it is used to treat. For instance, the stated dosage for the treatment of symptomatic GERD is different from the dosage used for complex conditions like Zollinger-Ellison syndrome. You should follow the dosage specifically prescribed or recommended by your healthcare provider.

Q: Is it safe to drink alcohol while taking Omeprazole?

Official regulatory documents covering drug interactions primarily address other medicines and herbal products. It is advisable to consult a healthcare provider for specific guidance regarding the consumption of alcohol while taking any medication, including Omeprazole.

How should Omicel be stored and disposed of?

Official Storage and Disposal Requirements

Omicel (Omeprazole delayed-release) must be stored at controlled room temperature, specifically between 20 C and 25 C (68 F and 77 F). To maintain stability and protect the enteric coating, the medication must be kept in its original container and protected from moisture and high humidity; the container must be kept tightly closed when not in use. Avoid storage in humid environments like bathrooms. The product must be stored out of the sight and reach of children.

For disposal, unused or expired Omicel should be discarded through a medicine take-back program. If a program is unavailable, mix the medication with an undesirable substance and place it in a sealed bag before throwing it in the household trash. Do not flush Omicel down the toilet or pour it into a drain.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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