Medical Editor: John P. Cunha, DO, FACOEP
Limbrel (flavocoxid) is a medical food product made up of substances from plant sources called flavonoids and flavans used to manage osteoarthritis (OA). Limbrel helps to decrease swelling (inflammation) and pain. Common side effects of Limbrel include:
- diarrhea, or
Tell your doctor if you have rare but serious side effects of Limbrel including yellowing eyes or skin. A very serious allergic reaction to Limbrel is unlikely, but seek immediate medical attention if you have symptoms including rash, itching or swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
For the clinical dietary management of the metabolic processes of osteoarthritis, take either one 250 mg or one 500 mg capsule every 12 hours for 500 mg to 1,000 mg total daily consumption as directed by a physician. There may be other drugs that can interact with Limbrel. Tell your healthcare provider about all your prescription and over-the-counter medications and supplements you use. Do not start a new medication without telling your healthcare provider. Limbrel is not recommended for use during pregnancy. It is not known whether this product passes into breast milk. Breastfeeding is not recommended while using this product.
Our Limbrel (flavocoxid) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Less serious side effects are more likely to occur, and you may have none at all.
Tell your doctor, pharmacist, herbalist, or other healthcare provider about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Limbrel (Flavocoxid)
In a randomized, double-blind placebo-controlled safety study of 60 days, subjects ingested either 125 mg of LIMBREL (flavocoxid) or placebo. Rates of symptomatic adverse events were low and did not differ between the LIMBREL (flavocoxid) and placebo arms. There were also no usage-related changes in routine hematological or biochemical safety parameters.
In a controlled clinical trial of 90 days duration, the incidence of clinical side effects and changes in routine hematological and biochemical parameters and incidence of fecal occult blood positivity were identical for the LIMBREL (flavocoxid) and placebo groups. Adverse events reported included increased varicose veins, elevated hypertension, fluid accumulation in the knee, psoriasis in the LIMBREL (flavocoxid) 125 mg BID arm, psoriasis in the LIMBREL (flavocoxid) 250 mg BID arm, and reduced flexibility in the placebo arm.
Adverse reactions were also collected in a double-blind, randomized clinical trial of 30 days, although this study was not designed to specifically assess usage-related differences in adverse events. Overall, no serious adverse events were reported for LIMBREL (flavocoxid) . There was a non-significant trend toward more frequent edema and nonspecific musculoskeletal events in the naproxen arm. No significant changes were observed within or between arms for weight, systolic blood pressure, or diastolic blood pressure. As expected in a trial of this duration, no fecal occult blood was detected in study subjects, including those taking naproxen.
In a retrospective study, 8 healthy adult subjects, ranging in age from 41 to 60 years, ingested LIMBREL (flavocoxid) daily for periods ranging from 5 to 11 months (mean 7 months). Daily amount ranged from 300 mg to 1,500 mg (mean of 825 mg). Six subjects were male and 2 were female. No subjects reported a prior history of gastrointestinal ulceration. Analysis for fecal occult blood was conducted on three consecutive days. No subjects in this trial were positive for fecal occult blood.
In a second retrospective study, 13 healthy adult subjects ranging in age from 38 to 58 ingested LIMBREL (flavocoxid) daily for periods ranging from 5 to 15 months (mean of 8 months). Daily administration ranged from 150 mg to 600 mg (mean of 375 mg). Seven subjects were male and 6 subjects were female. No subjects reported a prior history of gastrointestinal illness. Analysis for fecal occult blood was conducted on three consecutive days. No subjects in this trial were positive for fecal occult blood. One subject had an event of occult bleeding prior to the measurement date, withdrew from the product, and was unavailable for retrospective analysis. This subject was found to have an unreported prior history of gastrointestinal ulceration. The most commonly reported LIMBREL (flavocoxid) adverse event in all clinical trials is diarrhea and flatulence occuring in 5-8% of subjects. No subject has discontinued participation in a trial because of these symptoms.
Endoscopic examinations have not been conducted in LIMBREL (flavocoxid) users.
Patients Anticoagulated with Warfarin
LIMBREL (flavocoxid) was administered to 59 patients who were taking warfarin chronically. Prothrombin times measured 2 weeks after the addition of LIMBREL (flavocoxid) were unchanged in the majority of patients. In 2 patients the prothrombin time was lengthened and in 2 patients was shortened beyond 2 standard deviations. It is not known whether these represented variation in laboratory testing or reflect a CYP450 polymorphism affecting warfarin metabolism. Because of this, physicians are advised to check prothrombin time one to two weeks after initiating LIMBREL (flavocoxid) in patients anticoagulated with warfarin.
Clinical studies have not been performed to assess the safety and efficacy of LIMBREL (flavocoxid) in pediatric, geriatric, hepatic insufficiency, renal insufficiency, and immunologically compromised patient populations.
In post marketing surveillance of over 60,000 patients and 100,000 prescriptions of LIMBREL (flavocoxid) , a total of 53 cases of side effects were reported. The most serious side effects were 4 cases of edema, 1 case of upper gastrointestinal bleeding, and 3 cases of elevation of liver tests (ALT, AST and Alkaline phosphatase) all of which resolved without residual effects after discontinuing LIMBREL (flavocoxid) . Notably, no serious or acute cardiovascular events have been reported. One case of first trimester miscarriage has been reported in a patient taking 7 prescription drugs concomitantly (including 2 drugs with warnings against use during pregnancy). The relevance of this case to LIMBREL (flavocoxid) is unknown. No other serious events have been reported.
Read the entire FDA prescribing information for Limbrel (Flavocoxid)
© Limbrel Patient Information is supplied by Cerner Multum, Inc. and Limbrel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.