Esomeprazole Uses, Dosage, Side Effects & Price | DrugsAtlas
Authoritative Clinical Reference
Navigation
Therapeutic Class
Proton Pump Inhibitor (PPI)
Subclass
Substituted benzimidazole derivative
Speciality
Gastroenterology
Schedule (India)
Schedule H
Routes
Oral, Intravenous
Formulations
| Form | Strengths |
|---|---|
| Tablets (enteric-coated/delayed-release) | 20 mg, 40 mg |
| Capsules (delayed-release) | 20 mg, 40 mg |
| Powder for oral suspension (sachets) | 10 mg, 20 mg, 40 mg |
| Injection (lyophilized powder for reconstitution) | 40 mg per vial |
Adult indications
INDICATIONS + DOSING ā FOR CLINICIAN USE ONLY
Primary Indications (Approved / Standard in India)
1. Gastroesophageal Reflux Disease (GERD)
A. Non-erosive Reflux Disease (NERD) / Mild-to-Moderate GERD:
| Parameter | Details |
|---|---|
| Starting dose | 20 mg orally once daily, taken before breakfast |
| Titration | Not routinely required |
| Usual maintenance dose | 20 mg once daily |
| Maximum dose | 40 mg once daily |
| Duration | 4 weeks initially; extend to 8 weeks if healing incomplete |
B. Erosive Esophagitis:
| Parameter | Details |
|---|---|
| Starting dose | 40 mg orally once daily |
| Titration | Not applicable |
| Usual maintenance dose | 20 mg once daily (after healing) |
| Maximum dose | 40 mg once daily |
| Duration | 4ā8 weeks for healing; long-term maintenance at 20 mg if required |
Clinical Notes:
- Administer at least 30ā60 minutes before first meal of the day
- Reassess need for continued therapy periodically
- Rule out malignancy before initiating long-term therapy in patients with alarm features
2. Peptic Ulcer Disease (Gastric / Duodenal Ulcer)
A. Helicobacter pylori Eradication ā Triple Therapy:
| Parameter | Details |
|---|---|
| Starting dose | Esomeprazole 20 mg twice daily |
| Titration | Not applicable |
| Usual maintenance dose | 20 mg twice daily (as part of regimen) |
| Maximum dose | 20 mg twice daily |
| Duration | 10ā14 days |
Combination regimen:
- Esomeprazole 20 mg BD + Amoxicillin 1 g BD + Clarithromycin 500 mg BD
Clinical Notes:
- Verify local clarithromycin resistance patterns before prescribing
- Alternative regimens (bismuth-based quadruple therapy, sequential therapy) may be preferred in high-resistance areas
B. NSAID-Associated Ulcer ā Treatment:
| Parameter | Details |
|---|---|
| Starting dose | 20ā40 mg orally once daily |
| Titration | Not applicable |
| Usual maintenance dose | 20ā40 mg once daily |
| Maximum dose | 40 mg once daily |
| Duration | 4ā8 weeks |
C. NSAID-Associated Ulcer ā Prophylaxis:
| Parameter | Details |
|---|---|
| Starting dose | 20 mg orally once daily |
| Titration | Not applicable |
| Usual maintenance dose | 20 mg once daily |
| Maximum dose | 20 mg once daily |
| Duration | Duration of NSAID therapy in high-risk patients |
3. Zollinger-Ellison Syndrome / Pathological Hypersecretory Conditions
| Parameter | Details |
|---|---|
| Starting dose | 40 mg orally twice daily |
| Titration | Individualised based on acid output; may increase in 20 mg increments |
| Usual maintenance dose | 40ā80 mg twice daily (divided doses) |
| Maximum dose | 240 mg/day in divided doses |
| Duration | Long-term; as clinically indicated |
Clinical Notes:
- Specialist supervision mandatory
- Doses above 80 mg/day should be given in divided doses
- Periodic assessment of acid output and symptom control
4. Stress Ulcer Prophylaxis (ICU Setting)
| Parameter | Details |
|---|---|
| Starting dose | 40 mg IV once daily |
| Titration | Not applicable |
| Usual maintenance dose | 40 mg IV once daily |
| Maximum dose | 40 mg IV once daily |
| Duration | Until patient tolerates enteral feeding or ICU discharge |
Clinical Notes:
- Preferred in patients who are NPO or unable to take oral medications
- Transition to oral therapy as soon as feasible
- Reserve use for high-risk ICU patients (mechanical ventilation, coagulopathy, severe sepsis)
5. Prevention of Rebleeding After Endoscopic Haemostasis (Peptic Ulcer Bleed)
| Parameter | Details |
|---|---|
| Starting dose | 80 mg IV bolus over 30 minutes |
| Titration | Followed by continuous IV infusion at 8 mg/hour for 72 hours |
| Usual maintenance dose | After 72 hours: 40 mg orally once daily |
| Maximum dose | 80 mg IV bolus; 8 mg/hour infusion (total ~192 mg in first 24 hours) |
| Duration | IV for 72 hours, then oral for 4ā8 weeks |
Clinical Notes:
- Indicated following successful endoscopic haemostasis of high-risk ulcer stigmata
- Intermittent high-dose IV bolus (e.g., 40 mg IV BD) is an acceptable alternative where continuous infusion is not feasible
Secondary Indications ā Adults (Off-label, if any)
| Indication | Dose | Duration | Notes |
|---|---|---|---|
| Functional Dyspepsia ā OFF-LABEL | 20 mg once daily | 2ā4 weeks trial | Evidence: RCTs and Indian gastroenterology practice support short-term PPI trial for epigastric pain/discomfort unrelated to organic pathology. Reassess if no response. |
| Barrett's Oesophagus (Maintenance) ā OFF-LABEL | 40 mg once daily (may use twice daily under specialist guidance) | Long-term | Specialist only. Evidence: Standard of care in gastroenterology practice; aims to control reflux and potentially reduce dysplasia progression. Endoscopic surveillance mandatory. |
Paediatric indications
PAEDIATRIC DOSING (Specialist Only)
Primary Indications (Approved / Standard in India)
1. GERD / Erosive Oesophagitis ā Oral Route
Age: ≥1 year
| Weight | Starting Dose | Usual Maintenance | Maximum Dose | Duration |
|---|---|---|---|---|
| 10ā19 kg | 10 mg once daily | 10 mg once daily | 10 mg/day | 4ā8 weeks |
| 20ā40 kg | 10ā20 mg once daily | 10ā20 mg once daily | 20 mg/day | 4ā8 weeks |
| >40 kg | 20ā40 mg once daily | 20ā40 mg once daily | 40 mg/day | 4ā8 weeks |
Clinical Notes:
- Administer before meals
- Granules/oral suspension may be preferred in younger children unable to swallow capsules
- Monitor symptom response, weight gain, and any signs of GI bleeding
2. Erosive Oesophagitis ā Intravenous Route (when oral not feasible)
Age: ≥1 month
| Parameter | Details |
|---|---|
| Dose | 0.5ā1 mg/kg IV once daily |
| Maximum dose | 20 mg/day (for <20 kg); 40 mg/day (for ≥20 kg) |
| Duration | Until oral route tolerated |
Clinical Notes:
- Administer IV dose over 10ā30 minutes
- Convert to oral therapy as soon as clinically feasible
Age Restriction:
Not recommended below 1 month of age except under specialist paediatric gastroenterology supervision with clear clinical indication and risk-benefit assessment.
Not recommended below 1 month of age except under specialist paediatric gastroenterology supervision with clear clinical indication and risk-benefit assessment.
Secondary Indications ā Paediatrics (Off-label, if any)
| Indication | Age | Dose | Duration | Notes |
|---|---|---|---|---|
| H. pylori Eradication ā OFF-LABEL | ≥6 years | 1 mg/kg/dose twice daily (max 20 mg BD) with Amoxicillin + Clarithromycin | 10ā14 days | Specialist only. Evidence: Extrapolated from adult data and IAP recommendations. Weight-appropriate antibiotic dosing essential. |
Safety Monitoring (All Paediatric Patients):
- Assess symptom improvement at 4 weeks
- Monitor for adverse effects (headache, abdominal pain, diarrhoea)
- Periodic reassessment of need for continued therapy
- Long-term use: consider monitoring magnesium and B12 if therapy exceeds 12 months
Renal Adjustments
No dose adjustment required in renal impairment (mild, moderate, or severe).
| Renal Status | Recommendation |
|---|---|
| All stages of CKD | No dose adjustment required |
| Haemodialysis | Esomeprazole is not significantly removed by dialysis; no supplemental dose required |
| Peritoneal dialysis | No specific data; standard dosing generally acceptable |
Note: Use caution with prolonged therapy in severe renal impairment due to limited long-term safety data. Monitor for hypomagnesaemia if on concurrent diuretics.
Hepatic adjustment
Contraindications
- Known hypersensitivity to esomeprazole, omeprazole, or other substituted benzimidazole PPIs
- Concurrent use with atazanavir (results in significantly reduced atazanavir absorption and loss of antiretroviral efficacy)
- Concurrent use with rilpivirine (contraindicated due to substantial reduction in rilpivirine levels)
- Concurrent use with nelfinavir
Cautions
- Long-term use (>1 year): Risk of vitamin B12 deficiency, hypomagnesaemia, and bone fractures (hip, wrist, spine)
- Elderly patients: Higher susceptibility to hypomagnesaemia and fractures
- History of osteoporosis or fracture risk factors
- History of Clostridioides difficile infection or recent antibiotic use
- Chronic liver disease ā monitor hepatic function periodically
- Risk of masking gastric malignancy: Rule out malignancy (endoscopy recommended) before initiating long-term therapy in patients with alarm symptoms (weight loss, dysphagia, anaemia, haematemesis, persistent vomiting)
- Concurrent use of high-dose methotrexate
- Patients on clopidogrel ā assess risk-benefit
Pregnancy
| Parameter | Details |
|---|---|
| Overall safety | Limited human data; animal studies show no teratogenic effects |
| Risk category | Considered relatively safe (former FDA Category B equivalent) |
| Preferred alternatives | Pantoprazole generally preferred in Indian obstetric practice when PPI indicated |
| When to use | May be used when H2-receptor antagonists or antacids are inadequate and benefit outweighs potential risk |
| Monitoring | Maternal symptom control; fetal growth assessment if prolonged use |
Lactation
| Parameter | Details |
|---|---|
| Compatibility | Compatible with breastfeeding |
| Milk levels | Low ā limited excretion into breast milk |
| Preferred alternatives | None required; may use standard doses |
| Infant monitoring | Observe for feeding difficulties, unusual irritability, or diarrhoea (rare); monitor weight gain if mother on prolonged therapy |
Elderly
| Parameter | Recommendation |
|---|---|
| Starting dose | Same as adults (20ā40 mg once daily depending on indication) |
| Titration | Not routinely required |
| Special considerations | Increased risk of hypomagnesaemia (especially with concurrent diuretics), vitamin B12 deficiency, bone fractures (hip, wrist, spine), and Clostridioides difficile infection. Use lowest effective dose for shortest duration. Consider calcium and vitamin D supplementation in those with fracture risk. |
Major drug interactions
| Interacting Drug | Mechanism / Effect | Recommendation |
|---|---|---|
| Atazanavir | Reduced atazanavir absorption due to elevated gastric pH | Contraindicated ā avoid combination |
| Rilpivirine | Substantially reduced rilpivirine levels | Contraindicated ā avoid combination |
| Nelfinavir | Reduced nelfinavir absorption | Contraindicated ā avoid combination |
| Clopidogrel | Esomeprazole inhibits CYP2C19, reducing conversion of clopidogrel to active metabolite | Use with caution; consider alternative PPI (pantoprazole, rabeprazole) if PPI essential in patients on dual antiplatelet therapy |
| High-dose Methotrexate | PPIs may delay methotrexate clearance, increasing toxicity risk | Temporarily discontinue esomeprazole during high-dose methotrexate cycles |
Moderate drug interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Warfarin | Possible modest increase in INR | Monitor INR when starting, stopping, or changing esomeprazole dose |
| Ketoconazole, Itraconazole | Reduced absorption due to elevated gastric pH | Consider alternative antifungal or use azole that does not require acidic environment |
| Digoxin | Possible modest increase in digoxin absorption | Monitor serum digoxin levels, especially in patients at risk of toxicity |
| Tacrolimus | Slight increase in tacrolimus levels (CYP3A4 interaction) | Monitor tacrolimus trough levels |
| Diazepam | Modestly reduced clearance via CYP2C19 inhibition | Clinical monitoring; dose adjustment rarely needed |
| Phenytoin | Possible modest increase in phenytoin levels | Monitor phenytoin levels if symptoms of toxicity occur |
| Mycophenolate mofetil | Reduced exposure to mycophenolic acid | Clinical monitoring; may need dose adjustment in transplant patients |
| Iron supplements | Reduced iron absorption due to elevated gastric pH | Space administration or use iron formulations that do not require acidic environment |
Common Adverse effects
- Headache
- Abdominal pain
- Nausea
- Diarrhoea
- Constipation
- Flatulence
- Dry mouth
Serious Adverse effects
| Adverse Effect | Clinical Notes |
|---|---|
| Clostridioides difficile-associated diarrhoea (CDAD) | May occur during or after therapy; discontinue PPI and treat appropriately |
| Hypomagnesaemia | Risk with prolonged use (>1 year); may cause tetany, seizures, arrhythmias. Discontinuation usually reverses. |
| Vitamin B12 deficiency | With long-term use (>3 years); monitor and supplement if deficient |
| Acute interstitial nephritis | Rare; presents with acute kidney injury. Discontinue immediately and refer. |
| Bone fractures | Increased risk of hip, wrist, and spine fractures with long-term use, especially in elderly |
| Cutaneous lupus erythematosus / Subacute cutaneous lupus | Rare; discontinue if lupus-like rash develops |
| Fundic gland polyps | Associated with prolonged use; generally benign |
| Severe skin reactions (SJS/TEN) | Very rare; immediate discontinuation and hospitalisation required |
Monitoring requirements
Baseline:
- Clinical assessment of symptoms and alarm features
- Hepatic function tests (if hepatic history or planned long-term use)
- Consider endoscopy in patients with alarm symptoms before initiating long-term therapy
After initiation/dose change:
- Assess symptom response at 4 weeks
- If inadequate response to 8-week course: refer for endoscopy
Long-term (if therapy >12 months):
- Serum magnesium: every 6ā12 months (more frequently if on concurrent diuretics or digoxin)
- Serum vitamin B12: annually if on continuous therapy >3 years
- Bone mineral density (DEXA): consider in patients with osteoporosis risk factors on prolonged therapy
- Periodic reassessment of continued need for PPI therapy
Brands in India
| Brand Name | Manufacturer |
|---|---|
| Nexpro | Torrent Pharmaceuticals |
| Esoz | Sun Pharmaceutical |
| Esomac | Cipla |
| Nexium | AstraZeneca |
| Sompraz | Sun Pharmaceutical |
| Raciper | Cadila |
| Izra | Aristo |
Common Fixed-Dose Combinations (FDCs):
- Esomeprazole + Domperidone (e.g., Nexpro RD, Esoz D)
- Esomeprazole + Levosulpiride
Price range (INR)
| Formulation | Approximate Price |
|---|---|
| Tablet 20 mg (per tablet) | ā¹5ā10 |
| Tablet 40 mg (per tablet) | ā¹8ā15 |
| Injection 40 mg (per vial) | ā¹50ā100 |
| Sachet 20 mg / 40 mg (per sachet) | ā¹10ā20 |
Regulatory status: Esomeprazole is not individually listed in NLEM 2022 (omeprazole is listed); pricing not currently under NPPA ceiling control for most formulations.
Clinical pearls
- Administer correctly ā Take esomeprazole 30ā60 minutes before meals for optimal acid suppression; food reduces bioavailability.
- Do not use indefinitely without indication ā Reassess need for PPI therapy at least annually; many patients can be stepped down or discontinued.
- Endoscopy before long-term therapy ā In patients with alarm features (dysphagia, weight loss, anaemia, recurrent vomiting, GI bleeding), perform endoscopy to rule out malignancy before initiating prolonged PPI therapy.
- Clopidogrel interaction ā If a PPI is essential in patients on clopidogrel, consider pantoprazole or rabeprazole which have less CYP2C19 inhibition compared to esomeprazole/omeprazole.
- Monitor for deficiencies in long-term users ā Hypomagnesaemia and B12 deficiency are clinically significant; screen periodically in patients on therapy >1 year.
- Esomeprazole vs Omeprazole ā Esomeprazole (S-isomer) offers marginally more consistent acid suppression, but clinical superiority over omeprazole in most conditions is minimal. Choice may depend on availability and cost.
Version
RxIndia v1.0 ā 01 Jul 2025
Reference
- CDSCO product inserts
- Indian Pharmacopoeia / NFI
- API Textbook of Medicine, 11th Edition
- AIIMS Drug Formulary
- IAP Guidelines (Paediatric GERD Management)
- Indian Society of Gastroenterology Recommendations
- NLEM 2022 (omeprazole listed; esomeprazole referenced as therapeutic alternative)
- Harrison's Principles of Internal Medicine (supportive reference)
- Goodman & Gilman's The Pharmacological Basis of Therapeutics (pharmacology reference)
āļø
Clinical Responsibility
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.
Content Feedback
Is this information helpful?
Help us improve our clinical database for the medical community.