Note: This document contains side effect information about indomethacin. Some dosage forms listed on this page may not apply to the brand name Tivorbex.

Summary

Common side effects of Tivorbex include: headache. Other side effects include: dizziness, dyspepsia, hyponatremia, and nausea. Continue reading for a comprehensive list of adverse effects.

Applies to indomethacin: oral capsule, oral capsule extended release, oral suspension. Other dosage forms:

• intravenous powder for solution
• rectal suppository

Serious side effects of Tivorbex

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

Get emergency help immediately if any of the following symptoms of overdose occur while taking indomethacin:

Symptoms of overdose

• Confusion about identity, place, and time
• severe headache
• unusual drowsiness, dullness, or feeling of sluggishness

Other side effects of Tivorbex

Some side effects of indomethacin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Mild headache

Less common

• Continuing ringing or buzzing or other unexplained noise in the ears
• difficulty having a bowel movement (stool)
• discouragement
• feeling sad or empty
• general feeling of discomfort or illness
• hearing loss
• irritability
• loss of interest or pleasure
• sleepiness
• trouble with concentrating

Rare

• Anxiety
• bloated or full feeling
• changes in patterns and rhythms of speech
• excess air or gas in the stomach or intestines
• feeling of constant movement of self or surroundings
• involuntary muscle movements
• lightheadedness
• passing gas
• sensation of spinning
• tiredness
• trouble sleeping
• trouble with speaking

For Healthcare Professionals

Applies to indomethacin: compounding powder, intravenous powder for injection, oral capsule, oral capsule extended release, oral suspension, rectal suppository.

Gastrointestinal

Very common (10% or more): Nausea (up to 34%), vomiting (up to 12%)

Common (1% to 10%): Constipation, diarrhea, dyspepsia, upper abdominal pain, abdominal pain/distress, indigestion, heartburn, epigastric pain, gastrointestinal (GI) bleeding, gastrointestinal perforation, necrotizing enterocolitis

Uncommon (0.1% to 1%): Anorexia, bloating/distention, flatulence, peptic ulcer, gastroenteritis, rectal bleeding, proctitis, ulcerations/perforations/hemorrhage of the esophagus, stomach, duodenum, or small and large intestines, intestinal ulceration, stenosis, obstruction, development of ulcerative colitis, development of regional ileitis, ulcerative stomatitis, intestinal strictures, pancreatitis

Frequency not reported: Gastric perforation, gastritis, bleeding from sigmoid colon, perforation of existing sigmoid lesions, tenesmus, irritation of rectal mucosa, rectal burning/pain, rectal itching/discomfort, glossitis, esophageal lesions, tenesmus

Patent Ductus Arteriosus:

Common (1% to 10%): GI bleeding, GI perforation, necrotizing enterocolitis

Frequency not reported: Gross/microscopic bleeding into gastrointestinal tract, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforations of small/large intestines, melena^[Ref]

Hepatic

Borderline elevations of 1 or more liver function tests can occur in up to 15% of patients taking NSAIDs, including this drug. These elevations may progress, remain unchanged, or may be transient with continued treatment. Elevations of ALT or AST of 3 or more times the upper limit of normal have been reported in about 1% of patients in clinical trials with NSAIDs. Rare cases of severe hepatic reactions, including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure, some with fatal outcomes, have been reported.

Pediatric patients: There have been cases of hepatotoxicity, including fatalities, in pediatric patients with juvenile rheumatoid arthritis.^[Ref]

Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/AST

Frequency not reported: Cholestasis, abnormal liver function^[Ref]

Renal

In controlled clinical trials, renal dysfunction occurred statistically significantly more frequently during IV use in neonates than in those treated with placebo. Renal dysfunction has been reported in 41% of neonates and included at least 1 of the following: reduced urinary output, reduced urine sodium, chloride, or potassium; reduced urine osmolality, free water clearance, or GFR; elevated serum creatinine or BUN; or uremia.^[Ref]

Uncommon (0.1% to 1%): Nephrotic syndrome, interstitial nephritis, elevated BUN, renal insufficiency, renal failure

Patent Ductus Arteriosus:

Very common (10% or more): Renal dysfunction (41%)

Frequency not reported: Elevated serum creatinine, renal failure, elevated BUN^[Ref]

Metabolic

Common (1% to 10%): Decreased appetite

Uncommon (0.1% to 1%): Hyperglycemia, hyperkalemia, glycosuria, weight gain, fluid retention

Patent Ductus Arteriosus:

Common (1% to 10%): Hyponatremia, elevated serum potassium

Frequency not reported: Reduction in blood sugar/hypoglycemia, weight gain/fluid retention, metabolic acidosis, metabolic alkalosis^[Ref]

Hematologic

In a double blind placebo controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, there was statistically significant greater incidence of bleeding problems, including gross or microscopic bleeding in GI tract, oozing from skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy in infants treated with this drug (n=206). There was no statistically significant difference between treatment groups of intracranial hemorrhage.^[Ref]

Uncommon (0.1% to 1%): Leukopenia, bone marrow depression, anemia secondary to obvious or occult GI bleeding, aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenic purpura, disseminated intravascular coagulation

Frequency not reported: Leukemia, blood dyscrasias/hematopoietic disorders, neutropenia

Patent Ductus Arteriosus:

Common (1% to 10%): Bleeding

Frequency not reported: Disseminated intravascular coagulation, decreased platelet aggregation, thrombocytopenia^[Ref]

Nervous system

Very common (10% or more): Headache (up to 16%), dizziness (up to 15%)

Common (1% to 10%): Presyncope, somnolence, syncope, intracranial bleeding, fainting

Uncommon (0.1% to 1%): Drowsiness, lightheadedness, paresthesia, aggravation of epilepsy and Parkinsonism, coma, peripheral neuropathy, convulsion, dysarthria, aseptic meningitis, optic neuritis

Patent Ductus Arteriosus:

Very common (10% or more): Intraventricular hemorrhage (up to 14.3%), intracranial hemorrhage (up to 10.5%)

Common (1% to 10%): Intracranial bleeding, periventricular leukomalacia^[Ref]

Psychiatric

Common (1% to 10%): Depression, listlessness

Uncommon (0.1% to 1%): Anxiety, nervousness, insomnia, muzziness, psychic disturbances, psychotic episodes, mental confusion, depersonalization

Frequency not reported: Hallucinations^[Ref]

Cardiovascular

Common (1% to 10%): Hot flush

Uncommon (0.1% to 1%): Congestive heart failure, hypertension, hypotension, tachycardia, chest pain, arrhythmia, palpitations, angiitis

Frequency not reported: Thrombophlebitis, rapid fall in blood pressure resembling shock, cardiac failure, thrombotic events

Patent Ductus Arteriosus:

Frequency not reported: Bradycardia, hypertension, cardiac failure^[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash, sweating/hyperhidrosis, flushing, urticaria

Uncommon (0.1% to 1%): Petechiae, ecchymosis, exfoliative dermatitis, erythema nodosum, loss of hair/alopecia, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, angioedema, purpura

Very rare (less than 0.01%): Eczema

Frequency not reported: Fulminant necrotizing fasciitis, photosensitivity^[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Acute anaphylaxis

Very rare (less than 0.01%): Allergy-induced vasculitis

Frequency not reported: Hypersensitivity reactions

Patent Ductus Arteriosus:

Frequency not reported: Hypersensitivity reactions^[Ref]

Ocular

Uncommon (0.1% to 1%): Corneal deposits, retinal disturbances, blurred vision, diplopia

Frequency not reported: Orbital/periorbital pain, double vision

Patent Ductus Arteriosus:

Very common (10% or more): Retinopathy of prematurity (up to 21.1%)

Common (1% to 10%): Retrolental fibroplasia

Uncommon (0.1% to 1%): Blindness^[Ref]

Other

Very common (10% or more): Post-procedural edema (up to 26%), post-procedural hemorrhage (up to 11%)

Common (1% to 10%): Post-procedural swelling, vertigo, fatigue, malaise, tinnitus, asthenia, exhaustion

Uncommon (0.1% to 1%): Hearing disturbances, deafness, edema, fever

Postmarketing reports: Exacerbation of infection

Patent Ductus Arteriosus:

Frequency not reported: Exacerbation of infection, edema^[Ref]

General

The most frequently reported adverse effects were nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, dyspepsia, presyncope, rash, upper abdominal pain, somnolence, pruritus, hyperhidrosis, decreased appetite, hot flush, and syncope.

Patent Ductus Arteriosus: The most frequently reported adverse effects were bleeding problems, transient oliguria, and elevated serum creatinine.^[Ref]

Genitourinary

Information from various medical literature states that 44% of infants treated with this drug had oliguria. Renal dysfunction appears to be dose related; renal function usually returns to normal 24 hours following discontinuation.^[Ref]

Uncommon (0.1% to 1%): Hematuria, vaginal bleeding, proteinuria, breast enlargement/tenderness, gynecomastia

Frequency not reported: Urinary frequency

Patent Ductus Arteriosus:

Very common (10% or more): Oliguria (44%)

Frequency not reported: Transient oliguria^[Ref]

Local

Patent Ductus Arteriosus:

Frequency not reported: Bleeding/oozing from skin following needle puncture^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Muscle weakness, involuntary muscle movements

Frequency not reported: Hypercreatininemia, acceleration of cartilage degeneration^[Ref]

Respiratory

Uncommon (0.1% to 1%): Dyspnea, acute respiratory distress, asthma, pulmonary edema, epistaxis

Frequency not reported: Bronchospasm, pulmonary eosinophilia, alveolitis

Patent Ductus Arteriosus:

Frequency not reported: Pulmonary hemorrhage, pneumothorax, pulmonary hypertension, apnea, exacerbation of preexisting pulmonary infection^[Ref]