Description

Tivorbex is indicated for treatment of mild to moderate acute pain in adults.

Cautions

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

Side Effects

Treatments Pain Tivorbex Side Effects Print Save Tivorbex Side Effects Generic name: indomethacin Medically reviewed by Drugs.com. Last updated on Oct 1, 2021. Consumer Professional FAQ Note: This document contains side effect information about indomethacin. Some of the dosage forms listed on this page may not apply to the brand name Tivorbex. In Summary Common side effects of Tivorbex include: headache. Other side effects include: dizziness, dyspepsia, hyponatremia, and nausea. See below for a comprehensive list of adverse effects. For the Consumer Applies to indomethacin: oral capsule, oral capsule extended release, oral suspension Other dosage forms: intravenous powder for solution rectal suppository Warning Oral route (Capsule, Extended Release) NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs cause an increased risk of serious gastrointestinal adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events. Oral route (Suspension) NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at a greater risk for serious GI events. Oral route (Capsule) NSAIDs cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. Indomethacin is contraindicated in the setting of CABG surgery. NSAIDs can also cause an increased risk of serious gastrointestinal (GI) adverse events, including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events. Side effects requiring immediate medical attention Along with its needed effects, indomethacin (the active ingredient contained in Tivorbex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur while taking indomethacin: Less common Acid or sour stomach belching diarrhea heartburn indigestion nausea stomach discomfort, upset, or pain vomiting Rare Abdominal or stomach cramping, burning, or tenderness back or leg pains bleeding gums blistering, peeling, or loosening of the skin bloody or black, tarry stools blue lips and fingernails blurred vision breast enlargement and tenderness burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings burning upper abdominal or stomach pain canker sores change in consciousness change in hearing chest pain, discomfort, or burning clay colored stools cloudy or bloody urine confusion continuing diarrhea cough or hoarseness coughing that sometimes produces a pink frothy sputum cracks in the skin dark urine decreased appetite decreased vision or any change in vision depression difficult or labored breathing difficulty with swallowing dilated neck veins dizziness, faintness, or lightheadedness when getting up from a lying or sitting position double vision dry mouth extreme fatigue false sense of well-being feeling of unreality feeling of warmth fever with or without chills flushed, dry skin fruit-like breath odor general body swelling greatly decreased frequency of urination or amount of urine hair loss headache heavier menstrual periods increased hunger increased sweating increased thirst increased urination irregular breathing irritation and swelling of the eye jerky movements of the head, face, mouth, and neck joint pain large, flat, blue or purplish patches in the skin large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs loss of appetite loss of balance control loss of bladder control loss of consciousness loss of hearing loss of heat from the body lower back or side pain mask-like face mood swings muscle aches, pains, or weakness muscle spasm or jerking of all extremities nervousness noisy, rattling breathing nosebleeds numbness or tingling in the hands, feet, or lips pain in the ankles or knees pain or discomfort in the upper stomach or throat pain with swallowing painful or difficult urination painful, red lumps under the skin, mostly on the legs pale skin persistent bleeding or oozing from puncture sites, mouth, or nose personality changes pinpoint red or purple spots on the skin pounding in the ears puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue red skin lesions, often with a purple center red, irritated eyes red, swollen skin redness of the face, neck, arms and occasionally, upper chest scaly skin seeing double seeing, hearing, or feeling things that are not there seizures sense of detachment from self or body severe constipation severe mental changes severe or continuing stomach pain shuffling walk skin rash, hives or welts, itching slow, fast, irregular, pounding, or racing heartbeat or pulse slowed movements slurred speech small red or purple spots on the skin sore throat sores, ulcers, or white spots on the lips or tongue or inside the mouth stiffness of the arms and legs sudden loss of consciousness swelling of the breasts or breast soreness in both females and males swelling of the face, fingers, feet, ankles, or lower legs swollen or painful glands tightness in the chest trembling and shaking of the fingers and hands troubled breathing at rest troubled breathing with exertion unexplained weight loss unpleasant breath odor unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness vaginal bleeding vomiting of blood or material that looks like coffee grounds weakness in the arms, hands, legs, or feet weight gain yellow eyes or skin