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Pediatric Reference

Indomethacin Side EffectsComprehensive Pediatric Safety Guide

Indomethacin has a higher side-effect burden than many NSAIDs; GI and CNS effects are common.

3 Categories
5 Clinical Sources
Evidence-Based
Back to Indomethacin Overview

Essential Information

1

Give with food.

2

Monitor for GI bleeding and neurologic changes.

3

Assess renal function and urine output.

Clinical Overview

Serious adverse events include GI bleeding, renal impairment, and rare seizures in neonates.

Side Effect Categories

3 Systems

Gastrointestinal

2 documented effects

Total Sources: 2

Abdominal pain/nausea

Incidence: Common
Onset: Not specified
mild
1 sources
Duration

Not specified

Management

Take with food; consider gastroprotective agent for chronic use.

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

GI bleeding

Incidence: Uncommon
Onset: Not specified
serious
1 sources
Duration

Not specified

Management

Stop drug and seek urgent evaluation.

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Neurologic

2 documented effects

Total Sources: 2

Headache/dizziness

Incidence: Common
Onset: Not specified
mild
1 sources
Duration

Not specified

Management

Monitor; dose at bedtime if tolerated.

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Seizures (neonates)

Incidence: Rare
Onset: Not specified
serious
1 sources
Duration

Not specified

Management

Monitor neonates closely and discontinue if seizures occur.

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Renal

1 documented effect

Total Sources: 1

Reduced urine output

Incidence: Uncommon
Onset: Not specified
serious
1 sources
Duration

Not specified

Management

Assess renal function and discontinue if significant decline noted.

Monitoring Guidelines

Monitor for symptom escalation or new adverse effects.

1 clinical sources• PubMed • Clinical Guidelines • FDA

Parent Communication Guide

Age-Appropriate Explanations

Infants (0-12 months)

For babies taking Indomethacin, watch for signs of side effects. This medication is generally well-tolerated in infants when used as directed.

Toddlers (1-3 years)

If your toddler is taking Indomethacin, they might feel different. This is usually temporary and normal.

Children (4-12 years)

Take this medicine with food and tell us if your tummy hurts or you feel dizzy.

Adolescents (13+ years)

Report headaches, stomach pain, or less urine right away.

Common Parent Concerns

Q: Stomach upset

A: Take with meals and monitor for bleeding.

When to validate: Seek care for black stools or vomiting blood.

Q: Dizziness

A: Rest and avoid operating machinery; report persistent symptoms.

When to validate: Call if dizziness interferes with daily life.

Clinical Decision Support

Severity Assessment Framework

Clinical assessment framework for Indomethacin adverse effects using standardized severity grading.

Mild
Indicators: Minimal symptoms, No functional impairment, Patient comfortable continuing
Action: Continue medication with supportive care and routine monitoring
Moderate
Indicators: Noticeable symptoms, Some functional impact, Patient/family concerned
Action: Consider dose adjustment, increase monitoring frequency, provide supportive care
Severe
Indicators: Significant symptoms, Functional impairment, Quality of life affected
Action: Consider discontinuation, evaluate alternatives, close clinical follow-up

Treatment Decision Guidelines

Immediate Discontinuation

  • Severe allergic reactions
  • Life-threatening adverse effects
  • Signs of toxicity

Consider Alternatives

  • Persistent moderate side effects
  • Inadequate therapeutic response
  • Patient/family preference

Dose Modification

  • Mild side effects with good efficacy
  • Age-related sensitivity
  • Drug interaction concerns

Clinical References

IndomethacinMedlinePlus (2024)Drug information
Indometacin for arthritic conditionsMedicines for Children (2024)Patient information

Frequently Asked Questions

Parent and clinician concerns about Indomethacin