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Omeprazole Uses, Dosage, Side Effects & Price | DrugsAtlas

Authoritative Clinical Reference

Therapeutic Class

Proton Pump Inhibitor (PPI)

Subclass

Benzimidazole derivative

Speciality

Gastroenterology

Schedule (India)

schedule H

Routes

Oral, Intravenous

Formulations

Form	Available Strengths
Capsules (Enteric-coated)	10 mg, 20 mg, 40 mg
Tablets (Enteric-coated)	10 mg, 20 mg, 40 mg
Powder for Injection (IV)	40 mg vial
Oral Suspension (reconstituted)	2 mg/mL (prepared from sachets)

Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India)

1. Gastroesophageal Reflux Disease (GERD)

Parameter	Recommendation
Starting dose	20 mg orally once daily, 30–60 minutes before breakfast
Titration	Increase to 40 mg/day if inadequate response after 4 weeks
Usual maintenance dose	10–20 mg once daily
Maximum dose	40 mg/day
Duration	4–8 weeks for healing; reassess need beyond 8 weeks

2. Peptic Ulcer Disease — Duodenal Ulcer

Parameter	Recommendation
Starting dose	20 mg orally once daily
Titration	Increase to 40 mg/day in refractory cases
Usual maintenance dose	20 mg once daily
Maximum dose	40 mg/day
Duration	4 weeks (extend to 8 weeks if not healed)

3. Peptic Ulcer Disease — Gastric Ulcer

Parameter	Recommendation
Starting dose	20 mg orally once daily
Titration	Increase to 40 mg/day in refractory cases
Usual maintenance dose	20–40 mg once daily
Maximum dose	40 mg/day
Duration	8 weeks

Clinical Note: Rule out gastric malignancy before initiating therapy in patients with alarm features.

4. Helicobacter pylori Eradication (Triple Therapy)

Component	Dose	Frequency	Duration
Omeprazole	20 mg	Twice daily	14 days
Clarithromycin	500 mg	Twice daily	14 days
Amoxicillin	1000 mg	Twice daily	14 days

Alternative (Penicillin allergy):

Component	Dose	Frequency	Duration
Omeprazole	20 mg	Twice daily	14 days
Clarithromycin	500 mg	Twice daily	14 days
Metronidazole	400 mg	Twice daily	14 days

Parameter	Recommendation
Starting dose	20 mg twice daily
Titration	Not applicable
Usual maintenance dose	Not applicable (fixed regimen)
Maximum dose	20 mg twice daily

5. Zollinger-Ellison Syndrome

Parameter	Recommendation
Starting dose	60 mg orally once daily
Titration	Adjust based on gastric acid output; increase by 20 mg increments
Usual maintenance dose	60–120 mg/day (divide BID if >80 mg/day)
Maximum dose	180 mg/day in divided doses
Note	Specialist supervision mandatory; lifelong therapy often required

6. NSAID-induced Ulcer Prophylaxis

Parameter	Recommendation
Starting dose	20 mg orally once daily
Titration	Not applicable
Usual maintenance dose	20 mg once daily
Maximum dose	20 mg/day
Duration	Continue as long as NSAID therapy in at-risk patients

At-risk patients: Age >65 years, prior GI bleed, concurrent corticosteroid/anticoagulant use, high-dose NSAIDs.

7. Stress Ulcer Prophylaxis (ICU/Hospitalised Patients)

Parameter	Recommendation
Starting dose (IV)	40 mg IV once daily
Titration	Not applicable
Usual maintenance dose	40 mg IV once daily
Maximum dose	40 mg/day IV
Duration	Throughout high-risk period; transition to oral when feasible

Indications for prophylaxis: Mechanical ventilation >48 hours, coagulopathy, traumatic brain injury, severe burns, sepsis.

Secondary Indications — Adults (Off-label)

Indication	Dose	Duration	Notes
Functional dyspepsia	10–20 mg once daily before meals	2–4 weeks trial; reassess	OFF-LABEL; Indian gastroenterology practice; discontinue if no benefit
Erosive oesophagitis maintenance	10–20 mg once daily	Long-term	OFF-LABEL; based on international data and Indian specialist practice
Barrett's oesophagus (acid suppression)	20–40 mg once daily	Long-term with surveillance	OFF-LABEL; Specialist only; gastroenterology supervision
Laryngopharyngeal reflux	20 mg twice daily	8–12 weeks trial	OFF-LABEL; ENT/GI specialist supervision

Paediatric indications

PAEDIATRIC DOSING (Specialist Only)

Primary Indications

1. GERD and Erosive Oesophagitis

Weight/Age	Dose	Frequency	Duration
10–20 kg (≥1 year)	10 mg orally	Once daily	4–8 weeks
>20 kg (≥1 year)	20 mg orally	Once daily	4–8 weeks
Adolescents (≥12 years)	20 mg orally	Once daily	4–8 weeks

Parameter	Recommendation
Starting dose	Weight-based as above
Titration	May increase to 20 mg (10–20 kg) or 40 mg (>20 kg) if inadequate response
Maximum dose	40 mg/day (short-term)

2. Peptic Ulcer Disease (Paediatric)

Parameter	Recommendation
Dose	0.7–3.3 mg/kg/day orally in single or divided doses
Maximum dose	40 mg/day
Duration	4–8 weeks
Note	Specialist/paediatric gastroenterologist supervision

Secondary Indications — Paediatrics (Off-label)

Indication	Age	Dose	Duration	Notes
H. pylori eradication	≥5 years	1 mg/kg twice daily (max 20 mg BID) with antibiotics	14 days	OFF-LABEL; IAP-recognised practice; paediatric GI specialist

Paediatric Safety Notes

Parameter	Recommendation
Minimum age	≥1 year for standard indications
Infants <1 year	NOT RECOMMENDED except under paediatric gastroenterologist supervision
Safety concerns in infants	Risk of enteric infections, altered gut microbiome, possible increased respiratory infections
Monitoring	Clinical response; discontinue if no clear benefit after 4 weeks
Long-term use	Avoid unless essential; reassess periodically

Renal Adjustments

Renal Function	Dose Modification
All stages of CKD (eGFR any level)	No dose adjustment required
Haemodialysis	No supplemental dose needed; standard dosing
Peritoneal dialysis	No adjustment required

Hepatic adjustment

Contraindications

Known hypersensitivity to omeprazole, other substituted benzimidazoles (esomeprazole, pantoprazole, etc.), or any formulation excipient
Concurrent use with rilpivirine (pH-dependent absorption reduced → virological failure)
Concurrent use with nelfinavir (significantly reduced nelfinavir exposure)

Cautions

Prolonged therapy (>8–12 weeks): Risk of vitamin B12 deficiency, hypomagnesaemia, enteric infections
History of osteoporosis or fragility fractures: Use lowest effective dose; monitor bone health
Patients with alarm symptoms (dysphagia, weight loss, GI bleeding, anaemia): Rule out malignancy before starting
Concurrent clopidogrel therapy: Possible reduced antiplatelet efficacy (CYP2C19 interaction)
Elderly patients: Increased risk of Clostridioides difficile infection, fractures, hyponatraemia
Patients on high-dose or multiple daily dosing: Monitor magnesium levels
SLE patients: Reports of subacute cutaneous lupus erythematosus exacerbation

Pregnancy

Parameter	Recommendation
Overall safety	Generally considered compatible; most data support safety in 2nd and 3rd trimesters
First trimester	Limited data; no definitive evidence of teratogenicity; use if clearly indicated
Preferred alternatives	Pantoprazole (slightly more familiarity in Indian obstetric practice); antacids for mild symptoms
When to use	Severe GERD, peptic ulcer disease unresponsive to lifestyle measures/antacids
Monitoring	Standard antenatal care; symptom control assessment

Lactation

Parameter	Recommendation
Compatibility	Compatible with breastfeeding at standard doses
Drug levels in milk	Low (milk:plasma ratio approximately 0.05–0.3)
Preferred alternatives	Pantoprazole (also acceptable); famotidine for short-term use
Infant monitoring	Weight gain, GI symptoms (diarrhoea, colic) if prolonged maternal use

Elderly

Parameter	Recommendation
Starting dose	10 mg once daily for mild symptoms; 20 mg once daily for moderate-severe
Titration	Slow; increase only if inadequate response after 4 weeks
Maximum dose	40 mg/day (same as adults)
Extra risks	Hyponatraemia, vitamin B12 deficiency, hypomagnesaemia, hip/vertebral fractures, C. difficile infection
Duration	Limit to shortest effective duration; reassess need every 3–6 months

Major drug interactions

Interacting Drug	Effect	Recommendation
Clopidogrel	Reduced antiplatelet effect (CYP2C19 inhibition reduces active metabolite formation)	Avoid combination; use pantoprazole or rabeprazole as alternative PPI
Rilpivirine	Reduced rilpivirine absorption (pH-dependent) → HIV treatment failure	Contraindicated
Atazanavir	Reduced atazanavir absorption → treatment failure	Avoid combination; if essential, use boosted atazanavir with adjusted dosing
Nelfinavir	Significantly reduced nelfinavir exposure	Contraindicated
High-dose Methotrexate	Reduced renal clearance of methotrexate → toxicity	Avoid if possible; if unavoidable, monitor methotrexate levels closely; consider temporary PPI discontinuation
Citalopram/Escitalopram	Additive QT prolongation risk	Monitor ECG if combination unavoidable

Mechanism: Omeprazole is a CYP2C19 inhibitor (strong) and CYP3A4 inhibitor (weak).

Moderate drug interactions

Interacting Drug	Effect	Recommendation
Warfarin	May increase INR (reduced warfarin metabolism)	Monitor INR closely, especially on initiation/discontinuation
Phenytoin	Increased phenytoin levels (CYP2C19 inhibition)	Monitor phenytoin levels; adjust dose if needed
Digoxin	Increased digoxin absorption (reduced gastric acidity)	Monitor for digoxin toxicity, especially in elderly
Diazepam	Prolonged diazepam effect (reduced metabolism)	Monitor for excessive sedation
Oral iron supplements	Reduced iron absorption (increased gastric pH)	Separate administration by 2–3 hours; consider IV iron if refractory anaemia
Vitamin B12 (oral)	Reduced absorption with prolonged PPI use	Monitor B12 levels in long-term users; supplement if deficient
Calcium carbonate	Reduced calcium absorption	Consider calcium citrate instead for osteoporosis patients
Ketoconazole/Itraconazole	Reduced azole absorption (pH-dependent)	Avoid combination; use fluconazole if antifungal needed
Mycophenolate mofetil	Reduced mycophenolic acid exposure	Monitor immunosuppression efficacy
Tacrolimus	Possibly increased tacrolimus levels	Monitor tacrolimus levels

Common Adverse effects

Headache (most common)
Nausea
Diarrhoea
Constipation
Abdominal pain/bloating
Flatulence
Dizziness
Skin rash (non-serious)
Dry mouth
Taste disturbance

Serious Adverse effects

Adverse Effect	Clinical Notes
Clostridioides difficile–associated diarrhoea	Discontinue PPI; test for toxin; treat infection
Severe hypomagnesaemia	Usually with prolonged use (>3 months); may cause tetany, seizures, arrhythmias; check levels periodically
Vitamin B12 deficiency	Risk increases with duration >2–3 years; monitor and supplement
Acute interstitial nephritis	Rare; presents with AKI, eosinophilia; requires immediate discontinuation
Osteoporotic fractures	Hip, wrist, vertebral; risk with long-term high-dose use; use lowest effective dose
Stevens-Johnson syndrome/TEN	Very rare; discontinue immediately; hospitalisation required
Subacute cutaneous lupus erythematosus	Discontinue; rash may persist weeks after stopping
Fundic gland polyps	Benign; with long-term use; usually regress after stopping

Monitoring requirements

Timing	Parameters
Baseline	Exclude alarm symptoms (weight loss, dysphagia, GI bleed, anaemia) → consider endoscopy if present
At initiation	Serum electrolytes (especially if on diuretics); renal function
Short-term (4–8 weeks)	Symptom resolution; reassess indication
Long-term (>3 months)	Serum magnesium every 6 months
Long-term (>12 months)	Vitamin B12 levels annually; bone mineral density in high-risk patients
If on anticoagulants	INR monitoring on initiation and dose changes

Brands in India

Brand Name	Manufacturer	Notes
Omez	Dr. Reddy's	Most widely used
Ocid	Zydus Cadila
Omesec	Cipla
Nilsec	Mankind
Romesec	Ranbaxy/Sun
Omizac	Abbott
Omez-D	Dr. Reddy's	FDC with Domperidone
Omez-DSR	Dr. Reddy's	FDC with Domperidone SR

FDC combinations available: Omeprazole + Domperidone (common); Triple therapy kits (Omeprazole + Clarithromycin + Amoxicillin/Tinidazole)

Price range (INR)

Formulation	Approximate Price
Capsule 20 mg (strip of 10)	₹15–70
Capsule 20 mg (single)	₹1.50–7.00
Capsule 40 mg (strip of 10)	₹30–120
Injection 40 mg vial	₹20–60
Omez-D (Omeprazole 20 mg + Domperidone 10 mg) strip of 10	₹50–90

NLEM 2022 Status: Included — NPPA price ceiling applicable for scheduled formulations

Jan Aushadhi Availability: Yes — available at subsidised rates through government outlets

Clinical pearls

Timing is critical: Administer 30–60 minutes before the first meal of the day for optimal acid suppression; taking with or after meals significantly reduces efficacy.
Step-down approach: After 4–8 weeks of healing, attempt dose reduction or switch to H2 receptor antagonist/antacids; avoid indefinite PPI use without documented indication.
Clopidogrel interaction: When dual antiplatelet therapy with PPI is needed, prefer pantoprazole or rabeprazole over omeprazole; the clinical significance remains debated but the interaction is well-documented.
Rebound hypersecretion: Abrupt discontinuation after prolonged use (>8 weeks) may cause rebound acid hypersecretion; consider tapering by halving dose for 2–4 weeks before stopping.
H. pylori testing: Always test before treating; 14-day triple therapy is now preferred over 7-day regimens in India due to increasing clarithromycin resistance.
Not a substitute for lifestyle: Ensure patients understand that weight loss, dietary modification, and avoiding late meals are essential adjuncts, especially for GERD.

Version

RxIndia v1.1 — 30 May 2025

Reference

CDSCO approved prescribing information
Indian Pharmacopoeia (IP)
National List of Essential Medicines (NLEM) 2022
API Textbook of Medicine
ICMR H. pylori Management Guidelines
AIIMS Drug Formulary
IAP Paediatric Drug Formulary (paediatric dosing)
WHO Model Formulary (supportive paediatric data)
Goodman & Gilman's The Pharmacological Basis of Therapeutics

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This platform is designed strictly for healthcare professionals. Data provided is synthesized from authoritative pharmacological sources and clinical registries. Do not use for consumer medical decisions. Always verify critical dosing and contraindications with official institutional protocols and peer-reviewed journals.

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