Indocin Side Effects
Generic name: indomethacin
Medically reviewed by Drugs.com. Last updated on Mar 31, 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.
Applies to indomethacin: intravenous powder for solution. Other dosage forms:
Serious side effects of Indocin
Along with its needed effects, indomethacin (the active ingredient contained in Indocin) 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
- 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
- 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.
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
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]
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
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]
Frequently asked questions
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- 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?
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Patient resources
- Indocin drug information
- Indocin (Indomethacin Intravenous) (Advanced Reading)
- Indocin (Indomethacin Oral) (Advanced Reading)
- Indocin (Indomethacin Rectal) (Advanced Reading)
- Indocin (Indomethacin Suppositories)
- Indocin (Indomethacin Suspension)
Other brands
Professional resources
Other brands
Other formulations
Related treatment guides
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.