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Indocin IV Side Effects

Generic name: indomethacin

Medically reviewed by Drugs.com. Last updated on Feb 25, 2024.

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

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

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.

Serious side effects of Indocin IV

Along with its needed effects, indomethacin (the active ingredient contained in Indocin IV) 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

Rare

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

Symptoms of overdose

Other side effects of Indocin IV

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

Less common

Rare

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]

Frequently asked questions

References

1. Product Information. Indocin (indomethacin). Merck & Co., Inc. 2002;PROD.

2. Cerner Multum, Inc. UK Summary of Product Characteristics.

3. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.