Tivorbex

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 11/8/2021
Tivorbex Side Effects Center

What Is Tivorbex?

Tivorbex (indomethacin) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat mild to moderate acute pain in adults.

What Are Side Effects of Tivorbex?

Common side effects of Tivorbex include:

Dosage for Tivorbex

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.

What Drugs, Substances, or Supplements Interact with Tivorbex?

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.

Tivorbex During Pregnancy and Breastfeeding

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.

Additional Information

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.

QUESTION

Medically speaking, the term "myalgia" refers to what type of pain? See Answer
Tivorbex Consumer Information

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Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using indomethacin and call your doctor at once if you have:

  • a skin rash, no matter how mild;
  • changes in your vision;
  • heart problems--swelling, rapid weight gain, feeling short of breath;
  • signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, diarrhea, unusual tiredness, itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
  • signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

  • indigestion, nausea;
  • headache; or
  • dizziness.

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.

Read the entire detailed patient monograph for Tivorbex (Indomethacin Capsules)

SLIDESHOW

Back Pain: 16 Back Pain Truths and Myths See Slideshow
Tivorbex Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
  • GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
  • Hypertension [see WARNINGS AND PRECAUTIONS]
  • Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
  • Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
  • Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
  • Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
  • Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

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].

Postmarketing Experience

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 preexisting 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), pancreatitis.

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].

DRUG INTERACTIONS

See Table 2 for clinically significant drug interactions with indomethacin.

Table 2 Clinically Significant Drug Interactions with Indomethacin

Drugs That Interfere with Hemostasis
Clinical Impact:
  • Indomethacin and anticoagulants such as warfarin have a synergistic effect on bleeding. The concomitant use of indomethacin and anticoagulants have an increased risk of serious bleeding compared to the use of either drug alone.
  • Serotonin release by platelets plays an important role in hemostasis. Case-control and cohort epidemiological studies showed that concomitant use of drugs that interfere with serotonin reuptake and an NSAID may potentiate the risk of bleeding more than an NSAID alone.
Intervention: Monitor patients with concomitant use of TIVORBEX with anticoagulants (e.g., warfarin), antiplatelet agents (e.g., aspirin), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) for signs of bleeding [see WARNINGS AND PRECAUTIONS].
Aspirin
Clinical Impact: Controlled clinical studies showed that the concomitant use of NSAIDs and analgesic doses of aspirin does not produce any greater therapeutic effect than the use of NSAIDs alone. In a clinical study, the concomitant use of an NSAID and aspirin was associated with a significantly increased incidence of GI adverse reactions as compared to use of the NSAID alone [see WARNINGS AND PRECAUTIONS].
Intervention: Concomitant use of TIVORBEX and analgesic doses of aspirin is not generally recommended because of the increased risk of bleeding [see WARNINGS AND PRECAUTIONS].

TIVORBEX is not a substitute for low dose aspirin for cardiovascular protection

ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers
Clinical Impact:
  • NSAIDs may diminish the antihypertensive effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs), or beta-blockers (including propranolol).
  • In patients who are elderly, volume-depleted (including those on diuretic therapy), or have renal impairment, co-administration of an NSAID with ACE inhibitors or ARBs may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Intervention:
  • During concomitant use of TIVORBEX and ACE-inhibitors, ARBs, or beta-blockers, monitor blood pressure to ensure that the desired blood pressure is obtained.
  • During concomitant use of TIVORBEX and ACE-inhibitors or ARBs in patients who are elderly, volume-depleted, or have impaired renal function, monitor for signs of worsening renal function [see WARNINGS AND PRECAUTIONS].
  • When these drugs are administered concomitantly, patients should be adequately hydrated. Assess renal function at the beginning of the concomitant treatment and periodically thereafter.
Diuretics
Clinical Impact: Clinical studies, as well as post-marketing observations, showed that NSAIDs reduced the natriuretic effect of loop diuretics (e.g., furosemide) and thiazide diuretics in some patients. This effect has been attributed to the NSAID inhibition of renal prostaglandin synthesis.

It has been reported that the addition of triamterene to a maintenance schedule of indomethacin resulted in reversible acute renal failure in two of four healthy volunteers. Indomethacin and triamterene should not be administered together.

Both indomethacin and potassium-sparing diuretics may be associated with increased serum potassium levels. The potential effects of indomethacin and potassium-sparing diuretics on potassium levels and renal function should be considered when these agents are administered concurrently [see WARNINGS AND PRECAUTIONS].
Intervention: Indomethacin and triamterene should not be administered together. During concomitant use of TIVORBEX with diuretics, observe patients for signs of worsening renal function, in addition to assuring diuretic efficacy including antihypertensive effects.

Be aware that indomethacin and potassium-sparing diuretics may both be associated with increased serum potassium levels [see WARNINGS AND PRECAUTIONS].

Digoxin
Clinical Impact: The concomitant use of indomethacin with digoxin has been reported to increase the serum concentration and prolong the half-life of digoxin.
Intervention: During concomitant use of TIVORBEX and digoxin, monitor serum digoxin levels.
Lithium
Clinical Impact: NSAIDs have produced elevations in plasma lithium levels and reductions in renal lithium clearance. The mean minimum lithium concentration increased 15%, and the renal clearance decreased by approximately 20%. This effect has been attributed to NSAID inhibition of renal prostaglandin synthesis.
Intervention: During concomitant use of TIVORBEX and lithium, monitor patients for signs of lithium toxicity.
Methotrexate
Clinical Impact: Concomitant use of NSAIDs and methotrexate may increase the risk for methotrexate toxicity (e.g., neutropenia, thrombocytopenia, renal dysfunction).
Intervention: During concomitant use of TIVORBEX and methotrexate, monitor patients for methotrexate toxicity.
Cyclosporine
Clinical Impact: Concomitant use of TIVORBEX and cyclosporine may increase cyclosporine’s nephrotoxicity.
Intervention: During concomitant use of TIVORBEX and cyclosporine, monitor patients for signs of worsening renal function.
NSAIDs and Salicylates
Clinical Impact: Concomitant use of indomethacin with other NSAIDs or salicylates (e.g., diflunisal, salsalate) increases the risk of GI toxicity, with little or no increase in efficacy [see WARNINGS AND PRECAUTIONS].

Combined use with diflunisal may be particularly hazardous because diflunisal causes significantly higher plasma levels of indomethacin. [see CLINICAL PHARMACOLOGY]. In some patients, combined use of indomethacin and diflunisal has been associated with fatal gastrointestinal hemorrhage.

Intervention: The concomitant use of indomethacin with other NSAIDs or salicylates , especially diflunisal, is not recommended.
Pemetrexed
Clinical Impact: Concomitant use of TIVORBEX and pemetrexed may increase the risk of pemetrexedassociated myelosuppression, renal, and GI toxicity (see the pemetrexed prescribing information).
Intervention: During concomitant use of TIVORBEX and pemetrexed, in patients with renal impairment whose creatinine clearance ranges from 45 to 79 mL/min, monitor for myelosuppression, renal and GI toxicity.

NSAIDs with short elimination half-lives (e.g., diclofenac, indomethacin) should be avoided for a period of two days before, the day of, and two days following administration of pemetrexed.

In the absence of data regarding potential interaction between pemetrexed and NSAIDs with longer half-lives (e.g., meloxicam, nabumetone), patients taking these NSAIDs should interrupt dosing for at least five days before, the day of, and two days following pemetrexed administration.
Probenecid
Clinical Impact: When indomethacin is given to patients receiving probenecid, the plasma levels of indomethacin are likely to be increased.
Intervention: During the concomitant use of TIVORBEX and probenecid, a lower total daily dosage of indomethacin may produce a satisfactory therapeutic effect. When increases in the dose of indomethacin are made, they should be made carefully and in small increments.

Effects On Laboratory Tests

Indomethacin reduces basal plasma renin activity (PRA), as well as those elevations of PRA induced by furosemide administration, or salt or volume depletion. These facts should be considered when evaluating plasma renin activity in hypertensive patients.

False-negative results in the dexamethasone suppression test (DST) in patients being treated with indomethacin have been reported. Thus, results of the DST should be interpreted with caution in these patients.

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

© Tivorbex Patient Information is supplied by Cerner Multum, Inc. and Tivorbex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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