Omeprazole Uses, Dosage, Side Effects & Price | DrugsAtlas
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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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