Indocin Side Effects
Generic name: indomethacin
Note: This document contains side effect information about indomethacin. Some of the dosage forms listed on this page may not apply to the brand name Indocin.
Some side effects of Indocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to indomethacin: oral capsule, oral capsule extended release, oral suspension
Get emergency medical help if you have any of these signs of an allergic reaction while taking indomethacin (the active ingredient contained in Indocin) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:
chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
black, bloody, or tarry stools;
coughing up blood or vomit that looks like coffee grounds;
swelling or rapid weight gain;
urinating less than usual or not at all;
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
bruising, severe tingling, numbness, pain, muscle weakness.
Less serious side effects of indomethacin may include:
upset stomach, mild heartburn, diarrhea, constipation;
dizziness, nervousness, headache;
skin rash, itching;
blurred vision; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
For Healthcare Professionals
Applies to indomethacin: compounding powder, intravenous powder for injection, oral capsule, oral capsule extended release, oral suspension, rectal suppository
Gastrointestinal side effects reported frequently include dyspepsia, nausea, abdominal pain, and diarrhea. Constipation, anorexia, flatulence, gastroenteritis, proctitis, and stomatitis have been reported. More serious gastrointestinal effects include esophageal, peptic, and intestinal ulceration; gastrointestinal hemorrhage, with or without perforation; ileal and colonic strictures; and pancreatitis.
Single and multiple ulcerations may occur in the esophagus, stomach, and duodenum, as well as in the small and large intestines, and may be fatal in some patients. In rare cases, intestinal ulceration has been associated with stenosis and obstruction.
Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Indomethacin should be used with caution in these patients.
Indomethacin should be administered with food or antacids to reduce gastric irritation.
Elevations in liver function tests three times normal values occur in less than 1% of patients. Evaluation for possible serious hepatotoxicity in patients who develop significant elevations in liver function tests is recommended. Indomethacin-induced hepatitis has been associated with fatal outcome in some cases.
Hepatic side effects have included reports of elevation in liver function tests in up to 15% of patients. Rare cases of indomethacin induced hepatitis, cholestasis and jaundice have been reported.
Indomethacin may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for indomethacin-induced renal insufficiency are advanced age and concomitant use of diuretics.
A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
Patients with decreased renal function may be at increased risk for renal side effects. Cautious use of indomethacin (the active ingredient contained in Indocin) and close monitoring of renal function and electrolytes is recommended.
Renal insufficiency is reported and frequently manifests as increased serum creatinine and blood urea nitrogen and decreased urine output. Indomethacin has been implicated in cases of acute renal failure, nephrotic syndrome, interstitial nephritis, and renal papillary necrosis. Fatal renal failure has been reported.
Metabolic side effects have included hyponatremia, Syndrome of Inappropriate Antidiuretic Syndrome (SIADH), hyporeninemic hypoaldosteronism, hyperkalemia, hypocalcemia, and hyperglycemia.
Inhibition of intrarenal prostaglandin synthesis is thought to play a role in the pathogenesis of indomethacin-induced hyporeninemic hypoaldosteronism and subsequent hyperkalemia. Risk factors for the development of hyperkalemia include preexisting renal insufficiency, advanced age, diabetes mellitus, and extracellular volume depletion as well as concomitant use of potassium sparing diuretics, potassium supplements, and ACE inhibitors.
Hematologic side effects reported have included anemia, increased bleeding time, leukopenia, aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, and disseminated intravascular coagulation.
Anemia is usually a consequence of obvious or occult gastrointestinal bleeding.
Although hematologic abnormalities may be reversible upon discontinuation of indomethacin, indomethacin has been implicated in at least two cases of fatal aplastic anemia.
Central nervous system side effects such as headache, dizziness, vertigo, and drowsiness are not uncommon. These often respond to dose reduction but may require drug discontinuation. Convulsions, aggravation of epilepsy and parkinsonism, paresthesias, and peripheral neuropathy have been reported.
Psychiatric side effects, including psychosis, mental confusion, anxiety, mania, and depersonalization, are reported in less than 1% of patients. Insomnia has also been reported.
Indomethacin may aggravate preexisting psychiatric illness, including depression, psychoses, and anxiety. Cautious use in patients with a history of mental illness is recommended.
Precipitation of congestive heart failure is primarily due to indomethacin-induced sodium and water retention. Congestive heart failure may occur within two days of starting indomethacin (the active ingredient contained in Indocin) or following several years of therapy.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.
Cardiovascular side effects include peripheral edema, cerebral insufficiency, hyperventilation, and worsening of heart failure. Blood pressure may be elevated by indomethacin which may have clinical relevance in patients with co-morbid illnesses.
Dermatologic side effects reported include rash, pruritus, exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. Psoriasis and dermatitis herpetiformis may be worsened by indomethacin (the active ingredient contained in Indocin) therapy in some patients.
Hypersensitivity reactions include urticaria, angioedema, dyspnea, bronchospasm, hypotension, fever, angiitis, arthropathy, purpura, and anaphylaxis.
Retinal disturbances, including those of the macula and corneal deposits, are typically associated with prolonged indomethacin (the active ingredient contained in Indocin) use. During long-term indomethacin therapy, periodic ophthalmologic examinations are recommended. Any changes in vision noted by the patient should also prompt investigation.
Ocular side effects occur in less than 1% of patients. Corneal deposits, retinopathy, blurred vision, and diplopia have been reported.
Other non-immmune side effects reported include fetal hydrops with the use of indomethacin (the active ingredient contained in Indocin) tocolysis of only 30 hours.
More Indocin resources
- Indocin MedFacts Consumer Leaflet (Wolters Kluwer)
- Indocin Concise Consumer Information (Cerner Multum)
- Indocin Advanced Consumer (Micromedex) - Includes Dosage Information
- Indocin Monograph (AHFS DI)
- Indomethacin Prescribing Information (FDA)
- indomethacin MedFacts Consumer Leaflet (Wolters Kluwer)
- Indomethacin Professional Patient Advice (Wolters Kluwer)
- Indocin SR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
- Indocin SR Prescribing Information (FDA)
Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.