Indomethacin Side Effects

Brand Names: Indocin, Indocin SR

Please note - some side effects for Indomethacin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Indomethacin - for the Consumer

Indomethacin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indomethacin:

Redness, pain, or oozing at the injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in vomit, stool, or urine; dark, tarry stools; decreased urination; slow heartbeat; unusual bruising or bleeding; unusual weight gain.

Indomethacin Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indomethacin Capsules:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Indomethacin Suppositories

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indomethacin Suppositories:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; rectal irritation; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to urinate or pass a stool even though you have the urge; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Indomethacin Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indomethacin Suspension:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Indomethacin Sustained-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indomethacin Sustained-Release Capsules:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Indomethacin Side Effects - for the Professional

Indomethacin

In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving Capsules Indomethacin than in the group taking suppositories Indomethacin or placebo.

In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with suppositories or Indomethacin capsules was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group. The adverse reactions for Indomethacin capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between Indomethacin and these adverse reactions, some of which have been reported only rarely.

Causal Relationship Unknown

Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:

Cardiovascular:

Thrombophlebitis

Hematologic:

Although there have been several reports of leukemia, the supporting information is weak.

Genitourinary:

Urinary frequency

A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group A β hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including Indomethacin, sometimes with fatal outcome.

Side Effects by Body System

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

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

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.

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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