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Indocin Side Effects

Generic Name: indomethacin

Note: This page contains information about the side effects of indomethacin. Some of the dosage forms included on this document may not apply to the brand name Indocin.

In Summary

Common side effects of Indocin include: headache. Other side effects include: dizziness, dyspepsia, hyponatremia, and nausea. See below for a comprehensive list of adverse effects.

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 (the active ingredient contained in Indocin). In the event that any of these side effects do occur, they may require medical attention.

Severity: Major

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

Severity: Minor

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

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
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

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]

Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/AST
Frequency not reported: Cholestasis, abnormal liver function[Ref]

Renal

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]

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]

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]

References

1. Cerner Multum, Inc. "Australian Product Information." O 0

2. "Product Information. Indocin (indomethacin)." Merck & Co, Inc, West Point, PA.

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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

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