Indomethacin Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 4, 2024.

Applies to indomethacin: intravenous powder for solution.

Other dosage forms:

• oral capsule, oral capsule extended release, oral suspension
• rectal suppository

Serious side effects of indomethacin

Along with its needed effects, indomethacin 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 or nurse immediately if any of the following side effects occur while taking indomethacin:

More common side effects

• abdominal or stomach pain
• ammonia-like breath odor
• bloody or black, tarry stools
• coma
• confusion
• constipation
• convulsions
• decreased urine output
• difficult breathing
• dizziness
• fast or irregular heartbeat
• headache, sudden, severe
• increased thirst
• irregular heartbeat
• loss of appetite
• muscle pain or cramps
• nausea and vomiting
• nervousness
• numbness or tingling in the hands, feet, or lips
• severe stomach pain
• shortness of breath
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• weakness or heaviness of the legs
• weight loss

Less common side effects

• anxiety
• blurred vision
• chills
• cold sweats
• cool, pale skin
• depression
• full or bloated feeling
• heartburn
• increased hunger
• indigestion
• nightmares
• noisy, rattling breathing
• pressure in the stomach
• seizures
• severe abdominal or stomach pain, cramping, or burning
• severe constipation
• severe vomiting
• shakiness
• slurred speech
• swelling of the abdominal or stomach area
• swelling of the fingers, hands, feet, or lower legs
• troubled breathing at rest
• unusual bruising or bleeding
• vomiting of material that looks like coffee grounds, severe and continuing
• weight gain

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.

For Patent Ductus Arteriosus in Pediatric Patients:

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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

• 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

For Patent Ductus Arteriosus in Pediatric Patients:

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

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

Indomethacin 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.

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