Indomethacin Side Effects

Not all side effects for indomethacin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to indomethacin: oral capsule, oral capsule extended release, oral suspension

In addition to its needed effects, some unwanted effects may be caused by indomethacin. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking indomethacin:

Less common
  • Acid or sour stomach
  • belching
  • diarrhea
  • heartburn
  • indigestion
  • nausea
  • stomach discomfort, upset, or pain
  • vomiting
Rare
  • Abdominal or stomach cramping, burning, or tenderness
  • back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloody or black, tarry stools
  • blue lips and fingernails
  • blurred vision
  • breast enlargement and tenderness
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning upper abdominal pain
  • canker sores
  • change in consciousness
  • change in hearing
  • chest pain, discomfort, or burning
  • clay colored stools
  • cloudy or bloody urine
  • confusion
  • continuing diarrhea
  • cough or hoarseness
  • coughing that sometimes produces a pink frothy sputum
  • cracks in the skin
  • dark urine
  • decreased appetite
  • decreased vision or any change in vision
  • depression
  • difficult or labored breathing
  • difficulty with swallowing
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • double vision
  • dry mouth
  • extreme fatigue
  • false sense of well-being
  • feeling of unreality
  • feeling of warmth
  • fever with or without chills
  • flushed, dry skin
  • fruit-like breath odor
  • general body swelling
  • greatly decreased frequency of urination or amount of urine
  • hair loss
  • headache
  • heavier menstrual periods
  • increased hunger
  • increased sweating
  • increased thirst
  • increased urination
  • irregular breathing
  • irritation and swelling of the eye
  • jerky movements of the head, face, mouth, and neck
  • joint pain
  • large, flat, blue or purplish patches in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • loss of balance control
  • loss of bladder control
  • loss of consciousness
  • loss of hearing
  • loss of heat from the body
  • lower back or side pain
  • mask-like face
  • mental confusion
  • mood swings
  • muscle aches, pains, or weakness
  • muscle spasm or jerking of all extremities
  • nervousness
  • noisy, rattling breathing
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pain in the ankles or knees
  • pain or discomfort in the upper stomach, or throat
  • pain with swallowing
  • painful or difficult urination
  • painful, red lumps under the skin, mostly on the legs
  • pale skin
  • persistent bleeding or oozing from puncture sites, mouth, or nose
  • personality changes
  • pinpoint red or purple spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • red, swollen skin
  • redness of the face, neck, arms and occasionally, upper chest
  • scaly skin
  • seeing double
  • seeing, hearing, or feeling things that are not there
  • seizures
  • sense of detachment from self or body
  • severe constipation
  • severe mental changes
  • severe or continuing stomach pain
  • shuffling walk
  • skin rash, hives or welts, itching
  • slow, fast, irregular, pounding, or racing heartbeat or pulse
  • slowed movements
  • slurred speech
  • small red or purple spots on the skin
  • sore throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • stiffness of the arms and legs
  • sudden loss of consciousness
  • sugar in the urine
  • swelling in the legs and ankles
  • swelling of the face, fingers, feet, or lower legs
  • swelling of the breasts or breast soreness in both females and males
  • swollen or painful glands
  • tightness in the chest
  • trembling and shaking of the fingers and hands
  • troubled breathing at rest
  • troubled breathing with exertion
  • unexplained weight loss
  • unpleasant breath odor
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vaginal bleeding
  • vomiting of blood or material that looks like coffee grounds
  • weakness in the arms, hands, legs, or feet
  • weight gain
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking indomethacin, get emergency help immediately:

Symptoms of overdose
  • Confusion about identity, place, and time
  • severe headache
  • unusual drowsiness, dullness, or feeling of sluggishness

Some of the side effects that can occur with indomethacin may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Mild headache
Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty having a bowel movement (stool)
  • discouragement
  • feeling sad or empty
  • general feeling of discomfort or illness
  • hearing loss
  • irritability
  • loss of interest or pleasure
  • sleepiness
  • trouble with concentrating
Rare
  • Anxiety
  • bloated or full feeling
  • changes in patterns and rhythms of speech
  • excess air or gas in the stomach or intestines
  • feeling of constant movement of self or surroundings
  • involuntary muscle movements
  • lightheadedness
  • passing gas
  • sensation of spinning
  • tiredness
  • trouble with speaking
  • trouble sleeping

For Healthcare Professionals

Applies to indomethacin: compounding powder, intravenous powder for injection, oral capsule, oral capsule extended release, oral suspension, rectal suppository

Gastrointestinal

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.

Hepatic

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.

Renal

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 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

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.

Metabolic side effects have included hyponatremia, Syndrome of Inappropriate Antidiuretic Syndrome (SIADH), hyporeninemic hypoaldosteronism, hyperkalemia, hypocalcemia, and hyperglycemia.

Hematologic

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.

Hematologic side effects reported have included anemia, increased bleeding time, leukopenia, aplastic anemia, thrombocytopenia, agranulocytosis, hemolytic anemia, and disseminated intravascular coagulation.

Nervous system

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

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.

Cardiovascular

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 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

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 therapy in some patients.

Hypersensitivity

Hypersensitivity reactions include urticaria, angioedema, dyspnea, bronchospasm, hypotension, fever, angiitis, arthropathy, purpura, and anaphylaxis.

Ocular

Retinal disturbances, including those of the macula and corneal deposits, are typically associated with prolonged indomethacin 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

Other non-immmune side effects reported include fetal hydrops with the use of indomethacin tocolysis of only 30 hours.

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