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Tivorbex

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Tivorbex

Tivorbex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate acute pain in adults. Common side effects include nausea, edema, headache, dizziness, vomiting, constipation, and indigestion.

For treatment of mild to moderate acute pain, the dosage of Tivorbex is 20 mg three times daily or 40 mg two or three times daily. Tivorbex may interact with ACE (angiotensin converting enzyme) inhibitors, angiotensin II antagonists, captopril, losartan, aspirin or other salicylates, beta-blockers, cyclosporine, diflunisal, digoxin, diuretics, lithium, methotrexate, other NSAIDs, anticoagulants, and probenecid. Tell your doctor all medications and supplements you use. During pregnancy, Tivorbex should be used only if prescribed in the first 30 weeks. After 30 weeks, use of Tivorbex is not recommended as it can harm a fetus. Tis drug may pass into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

Our Tivorbex (indomethacin) 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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Tivorbex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Five hundred and fifty-four patients (554) received TIVORBEX 20 mg or 40 mg for up to 48 hours in two double-blind, placebo-controlled, clinical trials of acute pain following bunionectomy. The most frequent adverse reactions in these trials are summarized below.

Table 1 : Summary of Adverse Reactions ( ≥ 2% in TIVORBEX 20 mg or 40 mg group) - Phase 3 Studies in Patients With Postsurgical Pain

Any Treatment Emergent AE TIVORBEX 40 mg three times daily* (%)
N=187
TIVORBEX 40 mg twice daily* (%)
N=184
TIVORBEX 20 mg three times daily* (%)
N=183
Placebo* (%)
N=188
Nausea 33 33 34 36
Post procedural edema 24 22 26 32
Headache 16 14 11 11
Dizziness 15 14 10 17
Vomiting 8 10 12 11
Post procedural hemorrhage 5 11 5 6
Constipation 4 5 6 5
Pruritus 2 3 4 0
Diarrhea 2 3 2 1
Dyspepsia 3 2 1 1
Post procedural swelling 1 3 1 1
Presyncope 2 3 1 2
Rash 2 1 2 0
Abdominal pain, upper 2 1 2 1
Somnolence 2 2 1 1
Pruritus generalized 1 2 1 0
Hyperhidrosis 0 2 1 1
Decreased appetite 0 2 1 1
Hot flush 0 1 2 1
Syncope 0 2 1 1
*One tablet of hydrocodone/acetaminophen 10 mg/325 mg was permitted every 4 to 6 hours as rescue medication for pain management. There was a greater use of concomitant opioid rescue medication in placebo-treated patients than in TIVORBEX-treated patients [see Clinical Studies].

Adverse Reactions From Spontaneous Reports

The following adverse reactions have been identified during post approval use of indomethacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Gastrointestinal: anorexia, bloating (includes distension), flatulence, peptic ulcer, gastroenteritis, rectal bleeding, proctitis, single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small and large intestines intestinal ulceration associated with stenosis and obstruction, gastrointestinal bleeding without obvious ulcer formation and perforation of pre-existing sigmoid lesions (diverticulum, carcinoma, etc) development of ulcerative colitis and regional ileitis ulcerative stomatitis, toxic hepatitis and jaundice (some fatal cases have been reported), intestinal strictures (diaphragms).

Cardiovascular: hypertension, hypotension, tachycardia, chest pain, congestive heart failure, arrhythmia, palpitations.

Hematologic: leukopenia, bone marrow depression, anemia secondary to obvious or occult gastrointestinal bleeding, aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenic purpura, disseminated intravascular coagulation.

Central Nervous System: anxiety (includes nervousness), muscle weakness, involuntary muscle movements, insomnia, confusion, psychic disturbances including psychotic episodes, mental confusion, drowsiness, light-headedness, syncope, paresthesia, aggravation of epilepsy and parkinsonism, depersonalization, coma, peripheral neuropathy, convulsion, dysarthria.

Hypersensitivity: acute anaphylaxis, acute respiratory distress rapid fall in blood pressure resembling a shock-like state, angioedema, dyspnea, asthma, purpura, angiitis, pulmonary edema, fever.

Metabolic: edema, weight gain, fluid retention, flushing or sweating, hyperglycemia, glycosuria, hyperkalemia

Genitourinary: hematuria, vaginal bleeding, proteinuria, nephrotic syndrome, interstitial nephritis: BUN elevation, renal insufficiency, including renal failure.

Special Senses: ocular - corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with indomethacin; blurred vision, diplopia, hearing disturbances, deafness.

Skin and Appendages: pruritus, rash, urticaria, petechiae or ecchymosis, exfoliative dermatitis, erythema nodosum, loss of hair, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis.

Miscellaneous: epistaxis, breast changes, including enlargement and tenderness, gynecomastia

Causal relationship unknown

Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:

Cardiovascular: Thrombophlebitis

Hematologic: Although there have been several reports of leukemia, the supporting information is weak

Genitourinary: Urinary frequency

Musculoskeletal and Connective Tissue: A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group Ab hemolytic streptococcus, has been described in persons treated with nonsteroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Tivorbex (Indomethacin Capsules) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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