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Flavocoxid uses and side effects

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Introduction

  • Flavocoxid is a medical food (not a conventional drug) that contains a blend of flavonoids derived from plant sources.
  • It is primarily made from baicalin (from Scutellaria baicalensis) and catechin (from Acacia catechu).
  • Classified as a proinflammatory enzyme modulator, it has both anti-inflammatory and antioxidant properties.
  • It was marketed as a prescription-only medical food for the dietary management of osteoarthritis (OA).

Uses

  • Management of osteoarthritis symptoms (pain, stiffness, inflammation).
  • Alternative for patients who cannot tolerate traditional NSAIDs (non-steroidal anti-inflammatory drugs).
  • Claimed benefits included reducing inflammation by modulating COX-1, COX-2, and 5-LOX pathways.

Side Effects

Although considered safer than NSAIDs, flavocoxid is not free from risks. Reported adverse effects include:

  • Common, mild effects:
    • Stomach upset
    • Nausea
    • Diarrhea
    • Headache
  • Serious side effects (rare, but documented):
    • Liver injury (hepatotoxicity) – cases of elevated liver enzymes, hepatitis, and even serious liver damage have been reported.
    • Hypersensitivity reactions – rash, pruritus, anaphylaxis in rare cases.
    • Edema (fluid retention).

⚠️ Because of concerns about serious liver toxicity, flavocoxid was voluntarily withdrawn from the U.S. market in 2017.


  • Limbrel® (most recognized brand, in the U.S., marketed by Primus Pharmaceuticals).

Summary: Flavocoxid (Limbrel®) was a medical food for osteoarthritis, promoted as a safer alternative to NSAIDs. However, due to reports of serious liver injury and hypersensitivity reactions, it was withdrawn from the market.

FeatureFlavocoxid (Limbrel®)NSAIDs (e.g., Ibuprofen, Naproxen, Diclofenac)
ClassificationMedical food (flavonoid mixture: baicalin + catechin)Conventional drugs (non-steroidal anti-inflammatory drugs)
Mechanism of ActionModulates COX-1, COX-2, and 5-LOX enzymes (reduces pro-inflammatory mediators + antioxidant effects)Inhibit COX-1 and/or COX-2 → ↓ prostaglandin synthesis (anti-inflammatory, analgesic, antipyretic)
Approved UsesDietary management of osteoarthritis symptoms (pain, stiffness, inflammation)Pain relief, inflammation (OA, RA, gout, injuries), fever, dysmenorrhea, cardiovascular prophylaxis (low-dose aspirin)
AdministrationOral capsules (e.g., Limbrel 250 mg, 500 mg)Oral, topical, IV, suppository (varies by drug)
Common Side EffectsGI upset, nausea, diarrhea, headacheGI irritation, dyspepsia, nausea, headache, dizziness
Serious RisksHepatotoxicity (liver injury), hypersensitivity reactions (rash, anaphylaxis)GI ulcers/bleeding, renal impairment, hypertension, increased cardiovascular risk (MI, stroke)
Market StatusWithdrawn in 2017 (U.S.) due to liver injury casesWidely available worldwide
ToleranceInitially marketed as safer for GI tract vs NSAIDsMany patients experience GI side effects; some formulations (COX-2 inhibitors) developed to reduce GI toxicity
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