Tivorbex Side Effects

Generic name: indomethacin

Medically reviewed by Drugs.com. Last updated on Jul 15, 2024.

Note: This document provides detailed information about Tivorbex Side Effects associated with indomethacin. Some dosage forms listed on this page may not apply specifically to the brand name Tivorbex.

Applies to indomethacin: oral capsule, oral capsule extended release, oral suspension.

Other dosage forms:

• intravenous powder for solution
• rectal suppository

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Your doctor may recommend monitoring your blood pressure while using this medicine. .

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Check with your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing or speaking, headache, nausea, unusual sweating, or faintness.

This medicine may cause bleeding in your stomach or intestines. These problems can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (eg, steroid medicine or a blood thinner).

Check with your doctor right away if you have any symptoms of liver problems including dark-colored urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.

Serious skin reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms while taking this medicine: blistering, peeling, loosening of the skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin lesions, sore throat, sores, ulcers, white spots in the mouth or on the lips, or unusual tiredness or weakness.

Possible warning signs of some serious side effects that can occur during treatment with this medicine may include black, tarry stools, decreased urination, severe stomach pain, skin rash, swelling of the face, fingers, feet, or lower legs, unusual bleeding or bruising, unusual weight gain, vomiting of blood or material that looks like coffee ground, or yellow skin or eyes. Also, signs of serious heart problems could occur such as chest pain, tightness in the chest, fast or irregular heartbeat, unusual flushing or warmth of the skin, weakness, or slurring of speech. Check with your doctor immediately if you notice any of these warning signs.

This medicine may also cause a serious type of allergic reaction called anaphylaxis. Although this is rare, it may occur more often in patients who are allergic to aspirin or to any of the nonsteroidal anti-inflammatory drugs (NSAIDs). Anaphylaxis can be life-threatening and requires immediate medical attention. The most serious signs of this reaction are very fast or irregular breathing, gasping for breath, or fainting. Other signs may include changes in color of the skin of the face, very fast but irregular heartbeat or pulse, hive-like swellings on the skin, and puffiness or swellings of the eyelids or around the eyes. If these effects occur, get emergency help at once.

Using this medicine during the later part of a pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.

Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may cause some people to become dizzy, lightheaded, drowsy, or less alert than they are normally. Even if taken at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Before having any kind of surgery or medical tests, tell your doctor that you are taking this medicine. It may be necessary for you to stop treatment for a while, or to change to a different nonsteroidal anti-inflammatory drug before your procedure.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Common 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:

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:

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

For healthcare professionals

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

General adverse events

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]

Hepatic

• Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/AST
• Frequency not reported: Cholestasis, abnormal liver function^[Ref]

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]

Renal

• 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]

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]

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

• 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]

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]

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]

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]

Genitourinary

• 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]

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]

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]

See also:

Frequently asked questions

• What is Ardosons called in the U.S?
• Why is my poop green? What does this mean?
• Can I take Tylenol while taking indomethacin and can these drugs be alternated every 3 hours?

Further information

Tivorbex side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer