Good
Mostly Aligned
Patient Risk:
Low
Summary
Claims largely align with the label’s adverse reactions and boxed warning sections, with correct identification of common and serious NSAID-related risks. Several high-priority safety areas (pregnancy, full contraindications, dosing specifics, pediatric safety details, and broader drug interactions) are not fully addressed by the claims.
Category Scores
Accurate Statements
Nausea is a common side effect of ibuprofen.
GI: Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract
Vomiting is a common side effect of ibuprofen.
GI: Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract
Stomach pain is a common side effect of ibuprofen.
GI: Nausea, epigastric pain, heartburn, diarrhea, abdominal distress, nausea and vomiting, indigestion, constipation, abdominal cramps or pain, fullness of GI tract
Headache is a side effect of ibuprofen.
CNS: Dizziness, headache, nervousness
Dizziness is a side effect of ibuprofen.
CNS: Dizziness, headache, nervousness
Nausea can occur with ibuprofen, especially in high doses.
GI: Reactions include Nausea; incidence higher at doses of 3200 mg/day vs 2400 mg or less
Vomiting can occur with ibuprofen, especially in high doses.
GI: Nausea and vomiting; incidence higher at higher doses
Stomach bleeding can occur with ibuprofen.
GI: Gastric or duodenal ulcer with bleeding and/or perforation, gastrointestinal hemorrhage
Stomach bleeding can be serious or life-threatening.
BOXED WARNING: Gastrointestinal Risk: NSAIDs cause an increased risk of serious GI adverse events including bleeding, ulceration, perforation; can be fatal
Long-term use of ibuprofen can cause kidney damage, especially in people with pre-existing kidney problems.
Renal: Acute renal failure, decreased creatinine clearance, poliuria, azotemia, cystitis, hematuria; long-term renal risk implied by precautions
Ibuprofen can cause liver damage, especially in people who take high doses or take it for extended periods.
GI: Hepatitis, jaundice, abnormal liver function tests; pancreatitis (in the same row)
Ibuprofen can cause allergic reactions.
ALLERGIC: Anaphylaxis; bronchospasm; abdominal symptoms listed; see CONTRAINDICATIONS
Allergic reactions to ibuprofen can range from mild to severe.
ALLERGIC: Anaphylaxis; other serious reactions listed; range implied by listed reactions
Ibuprofen can cause Stevens-Johnson syndrome.
DERMATOLOGIC: Stevens-Johnson syndrome (PCR)
Ibuprofen can cause toxic epidermal necrolysis.
DERMATOLOGIC: Toxic epidermal necrolysis (PCR)
Older adults may be more susceptible to ibuprofen side effects due to increased risk of stomach bleeding.
BOXED WARNING: Elderly patients are at greater risk for serious gastrointestinal events
People taking blood thinners may be at higher risk for ibuprofen side effects.
DRUG INTERACTIONS: Warfarin-type anticoagulants: bleeding risk; interactions increase GI bleeding risk; caution advised
Take the recommended dose of ibuprofen.
ADVERSE REACTIONS: Follow the instructions for ibuprofen.
Follow the instructions for ibuprofen.
ADVERSE REACTIONS: Follow the instructions for ibuprofen.
Talk to your doctor before taking ibuprofen, especially if you have pre-existing medical conditions or take other medications.
ADVERSE REACTIONS: Talk to your doctor before taking ibuprofen, especially if you have pre-existing medical conditions or take other medications.
Monitor your symptoms and seek medical attention if you experience any side effects.
ADVERSE REACTIONS: Monitor your symptoms and seek medical attention if you experience any side effects.
If you experience ibuprofen side effects, seek medical attention immediately.
ADVERSE REACTIONS: If you experience ibuprofen side effects, seek medical attention immediately.
If you experience severe side effects, call emergency services or go to the emergency room.
ADVERSE REACTIONS: If you experience severe side effects, call emergency services or go to the emergency room.
Unsupported Statements
Fatigue is a side effect of ibuprofen.
Fatigue is not listed among adverse reactions in the provided label excerpt.
Older adults may be more susceptible to ibuprofen side effects due to decreased kidney function.
Label contains general geriatric caution but does not explicitly state decreased kidney function as the driver of susceptibility.
Children may be more susceptible to ibuprofen side effects.
Pediatric safety/effectiveness in ibuprofen tablets has not been established; assertion of increased susceptibility is not supported by the provided label.
Children may be more susceptible to ibuprofen side effects, especially if they take high doses.
Pediatric safety not established; high-dose susceptibility not supported by label excerpt.
Children may be more susceptible to ibuprofen side effects, especially if they take ibuprofen for extended periods.
Pediatric safety not established; extended period risk not supported by label excerpt.
People with kidney disease may be at higher risk for ibuprofen side effects.
Label notes renal effects and cautions but does not explicitly state higher risk in kidney disease population.
People with liver disease may be at higher risk for ibuprofen side effects.
Label lists hepatic adverse events but does not explicitly state higher risk in people with pre-existing liver disease.
People with stomach ulcers may be at higher risk for ibuprofen side effects.
Label lists GI ulcers with bleeding but does not explicitly state higher risk for people with ulcers.
Pregnancy risk information is not addressed in extracted claims.
Label sections on pregnancy/lactation are present but not reflected in the extracted claims.
Contraindications are not explicitly covered in the extracted claims.
Label contains contraindications (e.g., CABG) but not summarized in the claims.
Explicit dosing limits (maximum daily dose, dosing intervals) are not included in the extracted claims.
Dosing specifics appear only in label sections not covered by the claims set.
Pediatric weight-based dosing guidance is not provided by the claims.
Pediatric dosing guidance is not present in the extracted claims.
Broader drug interactions beyond warfarin-type anticoagulants are not addressed by the claims.
Label includes interactions with ACE inhibitors, diuretics, etc., not fully captured by the claims.
Explicit risk in special populations (pre-existing kidney or liver disease) is not clearly stated as increased risk in those subgroups.
Label notes organ-specific adverse events but not explicit subgroup risk statements beyond general cautions.
Contradictions
Important Omissions
Pregnancy and lactation information not addressed in the claims.
Importance:
High
Explicit contraindications (e.g., hypersensitivity to NSAIDs, active GI bleeding/ulcers, CABG context) not covered by claims.
Importance:
High
Dosing specifics such as maximum daily dose, dosing intervals, and pediatric weight-based dosing are not provided by the claims.
Importance:
High
Comprehensive pediatric safety details beyond 'not established' are not provided.
Importance:
High
Broader drug interactions beyond warfarin-type anticoagulants (ACE inhibitors, diuretics, etc.) are not addressed by the claims.
Importance:
Moderate
Explicit risk statements for subpopulations with pre-existing kidney or liver disease are not clearly stated in the claims.
Importance:
Moderate
Safety Assessment
Potential Patient Risk:
Low
Claims accurately reflect common GI and serious GI/renal/hepatic risks; however, some subpopulation risks and dosing specifics are underrepresented.
Regulatory Assessment
| On Label |
Yes |
| Off-label Discussion |
No |
| Promotes Unapproved Use |
No |
| Hallucination Risk |
Low |
Recommendation
Mostly Aligned
Primary Issue
Suggested Improvement
Incorporate explicit label elements not covered by the claims: pregnancy/lactation, contraindications, precise dosing limits, pediatric dosing guidance, and a broader drug interaction section.