Tolfenamic Acid Information
Medication Safety Issues
International issues:
Clotam Rapid brand name for tolfenamic acid [United Kingdom] may be confused with Cloftal brand name for chloramphenicol [Venezuela] and Clofoam brand name for clobetasol [Lebanon].
Tolfenamic acid may be confused with tiaprofenic acid.
Geriatric Patients: High-Risk Medication:
Beers Criteria: Based on pharmacologic class concerns for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) in the Beers Criteria, tolfenamic acid may be a potentially inappropriate medication to be avoided in patients ≥65 years (unless alternative agents ineffective and patient can receive concomitant gastroprotective agent) due to increased risk of GI bleeding and peptic ulcer disease in older adults in high risk category (eg, >75 years or receiving concomitant oral/parenteral corticosteroids, anticoagulants, or antiplatelet agents). May increase risk of acute kidney injury and further decline of kidney function in elderly patients with stages IV or higher chronic kidney disease or CrCl <30 mL/minute (Beers Criteria [AGS 2015]). Note: Updates for the American Geriatrics Society 2019 Updated AGS Criteria for Potentially Inappropriate Medication Use in Older Adults are in process.
Product Availability
Not available in the US
Storage/Stability
Store below 25°C (77°F)
Adverse Reactions
Frequency not defined:
Central nervous system: Aseptic meningitis, confusion, depression, dizziness, drowsiness, euphoria, fatigue, hallucination, headache, malaise, paresthesia, vertigo
Dermatologic: Bullous rash, skin photosensitivity, Stevens-Johnson syndrome
Gastrointestinal: Abdominal pain, aphthous stomatitis, constipation, diarrhea, dyspepsia, exacerbation of Crohns disease, exacerbation of ulcerative colitis, flatulence, gastrointestinal hemorrhage, gastrointestinal perforation, hematemesis, melena, nausea, peptic ulcer, vomiting
Genitourinary: Dysuria (more common in males), nephrotic syndrome, nephrotoxicity, urine discoloration
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hemolytic anemia, neutropenia, thrombocytopenia
Hepatic: Hepatic disease, hepatitis, jaundice
Neuromuscular & skeletal: Tremor
Ophthalmic: Optic neuritis, visual disturbance
Otic: Tinnitus
Renal: Interstitial nephritis, renal failure
<1%, postmarketing, and/or case reports: Gastritis, pancreatitis, toxic epidermal necrolysis
