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Indomethacin is a nonsteroidal anti-inflammatory drug (NSAID).
Indomethacin is used to treat moderate to severe osteoarthritis, rheumatoid arthritis, gouty arthritis, or ankylosing spondylitis. Indomethacin is also used to treat shoulder pain caused by bursitis or tendinitis.
Extended-release indomethacin (Indocin SR) should not be used to treat gouty arthritis.
Indomethacin may also be used for purposes not listed in this medication guide.
Indomethacin can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use indomethacin just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using indomethacin, especially in older adults.
Indomethacin can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).
Indomethacin may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using indomethacin, especially in older adults.
You should not use indomethacin if you are allergic to it, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.
Tell your doctor if you have ever had:
heart disease, high blood pressure;
a heart attack, stroke, or blood clot;
fluid retention;
bleeding problems;
stomach ulcers or bleeding;
asthma;
liver or kidney disease; or
if you smoke.
Taking indomethacin during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
This medicine may temporarily affect fertility (ability to have children) in women.
It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.
Indomethacin is not approved for use by anyone younger than 14 years old.
Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.
Swallow the extended-release capsule whole and do not crush, chew, break, or open it.
Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).
Your dose needs may change if you switch to a different brand, strength, or form of indomethacin. Avoid medication errors by using only the form and strength your doctor prescribes.
If you use this medicine long-term, you may need frequent medical tests.
If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.
Store at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe drowsiness, stomach pain, or vomiting.
Avoid alcohol. Heavy drinking can increase your risk of stomach bleeding.
Avoid taking aspirin unless your doctor tells you to.
Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to indomethacin (such as aspirin, ibuprofen, ketoprofen, or naproxen).
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using indomethacin and call your doctor at once if you have:
a skin rash, no matter how mild;
changes in your vision;
heart problems--swelling, rapid weight gain, feeling short of breath;
signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, diarrhea, unusual tiredness, itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
indigestion, nausea;
headache; or
dizziness.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ask your doctor before using indomethacin if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.
Ask a doctor or pharmacist before using indomethacin with any other medications, especially:
cyclosporine;
lithium;
methotrexate;
probenecid;
heart or blood pressure medication, including a diuretic or "water pill";
a blood thinner--warfarin, Coumadin, Jantoven; or
other NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, meloxicam, and others.
This list is not complete. Other drugs may affect indomethacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Further informationRemember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Indomethacin (www.drugs.com/mtm/indomethacin.html).
Commonly reported side effects of indomethacin include: headache. Other side effects include: dizziness, dyspepsia, hyponatremia, and nausea. See below for a comprehensive list of adverse effects.
For the ConsumerApplies to indomethacin: oral capsule, oral capsule extended release, oral suspension
Other dosage forms:
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.
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 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
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
GastrointestinalVery 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
HepaticBorderline 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.
Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/AST
Frequency not reported: Cholestasis, abnormal liver function
RenalIn 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.
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
MetabolicCommon (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
HematologicUncommon (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
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.
Nervous systemVery 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
PsychiatricCommon (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
CardiovascularCommon (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
DermatologicCommon (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
HypersensitivityUncommon (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
OcularUncommon (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
OtherVery 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
GeneralThe 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.
GenitourinaryUncommon (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
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.
LocalPatent Ductus Arteriosus:
Frequency not reported: Bleeding/oozing from skin following needle puncture
MusculoskeletalUncommon (0.1% to 1%): Muscle weakness, involuntary muscle movements
Frequency not reported: Hypercreatininemia, acceleration of cartilage degeneration
RespiratoryUncommon (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
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/27/2021.
Source: Drugs.com Indomethacin (www.drugs.com/mtm/indomethacin.html).
August 31, 2020
August 17, 2020
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March 31, 2021
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