Managing Pediatric Drug-Induced Dyspepsia with H2 Receptor Antagonists: Indian Paediatricians' Perspectives

Drugs are identified as a frequent cause of new-onset dyspeptic symptoms, like upper abdominal pain, early sense of satiety, epigastric discomfort or pain in the upper abdomen or behind the breastbone, flatulence, nausea, and vomiting. These symptoms are dose-dependent and individual-specific, like age, sex, genetic, and physiological factors, and any pre-existing conditions.

The ROME IV criteria define functional dyspepsia in adults as postprandial fullness (3days/week), early satiety (3days/week), epigastric pain, or burning (one day per week) lasting ≥3 months, with onset ≥6 months before diagnosis and no structural disease. In children, similar symptoms must persist for ≥2 months, with other conditions excluded. However, no definition exists for drug-induced dyspepsia in either adults or children.

The EMPACIP study, published in the May 2025 issue of Cureus, involved a panel of 24 pediatric specialists from India who evaluated the severity of dyspepsia for the commonly prescribed drugs. They emphasized that Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) like ibuprofen and mefenamic acid, combined with paracetamol, are linked with severe dyspeptic symptoms in children, while antimicrobials, corticosteroids, and iron or zinc supplements also contribute to these symptoms, but to a lesser extent.

For managing drug-induced dyspepsia in children, avoiding the responsible drug is preferred. Acid-reducing medications (ARMs) and prokinetics are first-line options. Among ARMs, Proton Pump Inhibitors (PPIs) are most commonly prescribed, but evidence is limited. PPIs should be reserved for high-risk cases as their combination with NSAIDs or steroids increases side effects, disrupts bone metabolism, and raises fracture and infection risks, so they should be cautiously prescribed.

Histamine-2 Receptor Antagonists (H2RAs) are proposed as promising alternatives to PPIs due to their rapid action and safety profile. The panel of 24 pediatric specialists from India also supported the use of H2RAs for managing drug-induced dyspepsia with following recommendations:

1. Drug-induced dyspepsia includes symptoms like bothersome postprandial fullness, early satiety, epigastric pain, or burning after starting a new medication.

2. Routine prophylactic ARM use with dyspepsia-inducing medications is not recommended.

3. ARMs should be used on an as-needed basis, initiated when symptoms arise, and discontinued within 72 hours after resolution.

4. H2RAs (ranitidine, famotidine) are preferred over PPIs due to their rapid onset of action.

Effectiveness of H2RAs in managing drug-induced dyspepsia in children

Dr. Somashekara H.R, Consultant Paediatric Hepatologist and Gastroenterologist at Narayana Health City, Bangalore, said, “In cases of drug-induced dyspepsia, the need is for immediate symptom control. H2 receptor antagonists (H2RAs) offer rapid action, making them highly valuable in such situations. I routinely co-prescribe an H2RA whenever a medication is likely to cause gastritis. They are useful, effective and fast-acting.”

Deciding on co-prescribing H2RAs

Dr Utkarsh Bansal, Pediatrician, Om Child Care and Vaccination Clinic, Lucknow, said, “In pediatric practice, deciding whether to co-prescribe an acid-reducing medication (ARM) requires a careful balance between symptom relief and the risk of over-prescription. My approach follows these core principles:

​1. Identifying High-Risk Medication Classes: like NSAIDs (and their combinations), specific antibiotics (Amoxicillin/Clavulanic acid, Azithromycin, Cefuroxime), and corticosteroids.

​2. Symptom-Driven vs. Prophylactic Use: ARMs should not be prescribed reflexively or 'just in case.' Instead, I follow the guideline that ARMs should be used for drug-induced dyspepsia only when symptoms actually occur. This avoids unnecessary medication exposure in children.

​3. Preference for H2RAs (like Ranitidine) for Rapid Relief: When co-prescription is necessary, H2RAs are preferred due to their rapid action and safety profile.

​4. Defined Duration of Therapy: The use of ARMs need to be limited in duration and generally stopped within 72 hours once the symptoms are managed.”

H2RAs, a safer alternative to PPIs for pediatric patients with drug-induced dyspepsia

Dr Arun Wadhwa, Pediatrician, Dr Wadhwa’s Clinic, Delhi, said, “We have been using H2 receptor antagonists (H2RAs) for many years. They are a safer alternative and can be used even in small children, including neonates. They provide immediate relief and are generally well tolerated. It is a gentle acid suppressant relevant for children. “

The study reiterates that PPIs should be prescribed with caution and reserved for high-risk cases, while H2RAs such as ranitidine are considered safer alternatives for managing drug-induced dyspepsia in children.

Reference: Pai U A, Ravishankar A, Bharadia L, et al. (May 07, 2025) Evidence-Based Review by a Multidisciplinary Team of Pediatricians on the Use of Gastric Acid-Reducing Medications in Children: Indian Perspectives. Cureus 17(5): e83653. doi:10.7759/cureus.83653