Indomethacin is an active pharmaceutical ingredient in the Acetic Acid Derivatives and Related Substances group (M01AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
GBOfficial regulatory label· revised June 6, 2025[1]
Indometacin is a non-steroidal anti-inflammatory agent indicated for the active stages of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, degenerative joint disease of the hip, acute musculoskeletal disorders, low back pain and acute gout.
Also indicated in inflammation, pain and oedema following orthopaedic procedures and the treatment of pain and associated symptoms of primary dysmenorrhoea. Since indometacin is not a simple analgesic, its use should be limited to the above conditions.
How to take
CACanada· Health Canada
7 products
Uses
CAOfficial regulatory label· revised March 22, 2025[2]
TEVA-INDOMETHACIN (indomethacin capsules) is indicated for the symptomatic treatment of the following: Rheumatoid Arthritis TEVA-INDOMETHACIN may be used singly or in combination with other agents. However, it should not be used as a drug of first choice because of the adverse reactions that may occur with its use.
Best results (relief of pain, tenderness, swelling and stiffness) have been obtained in the acute episodes of the disease. However, in many patients with chronic rheumatoid arthritis, indomethacin produces a significant lessening of pain and stiffness within 48 hours.
In other patients, treatment must be continued longer before significant subjective relief or objective evidence of decreased joint swelling and tenderness occur. In some cases of chronic rheumat oid arthritis, it may be necessary to continue treatment for at least a month before concluding that it has not produced significant benefit.
Use of TEVA-INDOMETHACIN may enable reduction of steroid dosage in patients receiving corticosteroids. In such instances, the steroid dosage should be reduced slowly. Ankylosing (Rheumatoid) Spondylitis TEVA-INDOMETHACIN frequently produces marked relief of pain and improved motion of the spine within 3 to 10 days.
USUnited States· FDA
5 products
Uses
USOfficial regulatory label· revised May 27, 2026[3]
1 INDICATIONS AND USAGE Indomethacin capsules are indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis Indomethacin capsules are nonsteroidal anti-inflammatory drug indicated for: Moderate to severe rheumatoid arthritis including acute flares of chronic disease Moderate to severe ankylosing spondylitis Moderate to severe osteoarthritis Acute painful shoulder (bursitis and/or tendinitis) Acute gouty arthritis ( 1 )
How to take
Drug interactions
Known interactions involving Indomethacin. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 500. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[2]Health Canada (DPD) · 00337420 · revised March 22, 2025
[3]FDA DailyMed · 009097a5-2c1e-4f… · revised May 27, 2026 [PDF]
[4]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
GBOfficial regulatory label· revised June 6, 2025[1]
The dosage of indometacin should be carefully adjusted to suit the need of the individual patient. In order to reduce the possibility of gastrointestinal disturbances, indometacin capsule should always be taken with food, milk or antacid and in chronic conditions start the therapy with a low dosage, increasing as required and continuing a trail of therapy for an adequate period (in some cases up to one month), will give the best results with a minimum of unwanted reactions.
Adult dosage :
The recommended oral dosage range is 50-200mg daily in divided doses.
Acute rheumatoid arthritis:
Initially 25mg two or three times a day. Chronic rheumatic disorders: 25mg two or three times daily. (If response is inadequate, gradually increase by 25mg. Adequate response is usually achieved with not more than 150mg daily, rarely more than 200mg daily).
Sudden flare up of chronic condition:
Increase if necessary, by 25mg daily until a satisfactory response is obtained, or a dosage of 150-200mg daily is reached. (If this causes any adverse effects, it should be reduced to a tolerable level for two or three days, then carefully increased, as tolerated).
Acute musculoskeletal disorders:
Initially 50mg two or three times daily, according to severity for 10-14 days. Normally 150mg daily, rarely 200mg daily. Lumbago: 50mg two or three times daily, according to severity. Duration of treatment is not normally more than five days, but may be continued for up to 10 days.
Gouty arthiritis:
Acute attack: 50mg three or four times daily until symptoms subside.
Following orthopaedic procedures:
Normally 100-150mg daily in divided doses until symptoms subside.
Additional considerations:
In conditions where patients require a dosage of 150- 200mg a day, it is often possible to reduce this gradually to a maintenance level of 75-100mg a day. In patients with persistent night pain and/or morning stiffness, a dose of up to 100mg at bed time may be helpful in affording relief.
It is rarely necessary to exceed a dosage of 200mg a day. Dosage in dysmenorrhoea : up to 75mg a day, starting with the onset of cramps or bleeding, and continuing for as the symptoms last.
Children :
Paediatric dosage is not established.
Elderly :
The elderly are at increased risk of the serious consequences of adverse reactions. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.
4) Method of Administration; For oral administration. To be taken preferably with or after food.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised June 6, 2025[1]
Blood and lymphatic disorders:
Infrequently, blood dyscrasias may occur including leucopenia, neutropenia, petechiae or ecchymosis, purpura, apalastic or haemolytic anaemia, agranulocytosis, bone-marrow depression, disseminated intra-vascular coagulation, and particularly thrombocytopenia.
Because some patients may develop anaemia secondary to obvious or occult gastro-intestinal bleeding, appropriate blood determinations are recommended. Epistaxis has been reported rarely.
Hypersensitivity :
Hypersensitivity reactions have been reported following treatment with NSAIDs. These may consists of (a) non specific allergic reaction and anaphylaxis (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or (c) assorted skin disorders including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Metabolism and nutrition disorders:
Hyperglycaemia, glycosuria, hyperkalaemia, sweating has been reported rarely.
Nervous system disorders :
Visual disturbances, headaches, paraesthesia, dizziness and lightheadedness are common side effects. Starting therapy with a low dose and increasing gradually minimises the incidence of headache. These symptoms frequently disappear on continued therapy or reducing the dosage, but if headache persists despite dosage reduction, indometacin should be withdrawn.
4), depression, confusion, vertigo, malaise, fatigue, dysarthria, syncope, coma, cerebral oedema, nervousness, mental confusion, anxiety and other psychiatric disturbances, muscle weakness, involuntary muscle movements, depersonalisation, hallucinations, drowsiness, convulsions and aggravation of epilepsy and parkinsonism, peripheral neuropathy, involuntary movements and insomnia.
These effects are often transient and abate or disappear frequently on reduced or stopping treatment. However, the severity of these may, on occasion, require cessation of therapy.
Eye disorders :
Infrequently blurred vision, diplopia, optic neuritis and orbital and peri-orbital pain. Corneal deposits and retinal or macular disturbances have been reported in patients with rheumatoid arthritis on prolonged therapy; but similar changes may be expected in such patients who have not received indometacin.
Ophthalmic examinations are desirable in patients given prolonged treatment.
Ear and labyrinth disorders :
Tinnitus, hearing disturbance (rarely deafness).
Cardiac disorders:
Oedema has been reported in association with NSAID treatment. Other adverse events reported less commonly include increased blood pressure, tachycardia, chest pain, arrhythmia, palpitation, hypotension, congestive heart failure (all infrequent).
Vascular disorders :
Flushing has been reported rarely Respiratory, thoracic and mediastinal disorders : Pulmonary eosinophilia. Bronchospasm may be precipitated in patient suffering from or with a history of bronchial asthma or allergic disease.
Gastrointestinal disorders:
The most commonly-observed adverse events are gastrointestinal in nature. Anorexia, epigastric discomfort,ulceration at any point in the gastro-intestinal tract (even with resultant stenosis and obstruction), bleeding (even without obvious ulceration or from a diverticulum) and perforation of preexisting sigmoid lesions (such as diverticulum or carcinoma), increased abdominal pain or exacerbation of the condition in patients with ulcerative colitis or Crohns disease (or the development of this condition), intestinal strictures and regional ileitis have been rarely reported.
Occasionally severe reactions stopping therapy, ulceration of the oesophagus, stomach or duodenum, sometimes with haemorrhage and perforation; gastro-intestinal tract bleeding. Rarely intestinal ulceration followed by stensis and obstruction has been reported.
4 Special warnings and precautions for use). If gastro- intestinal bleeding does occur treatment with indometacin should be discontinued. Gastro-intestinal disorders which occur can be reduced by giving indometacin with food, milk or antacids.
4) have been reported following administration. Less frequently, gastric has been observed. Pancreatitis has been reported very rarely.
Hepatobiliary disorders :
Cholestasis, borderline elevations of one or more liver tests may occur, and significant elevations of ALT (SGPT) or AST (SGOT) have been seen in less than 1% of patients receiving therapy with NSAIDs in controlled clinical trials.
If abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations such as rash or eosinophilia occur, indometacin should be stopped. Abnormal liver function, hepatitis and jaundice are infrequent.
Skin and subcutaneous tissue disorders :
Pruritus, urticaria, angioneurotic oedema angitis, erythema nod sum, skin rash, photosensitivity, exfoliative dermatitis. Bullous reactions including Steven Johnson syndrome, erythema multiform, toxic epidermal necrolysis, loss of hair, rapid fall in blood pressure resembling a shock like state, acute respiratory distress including sudden dyspnoea, asthma and pulmonary oedema (all infrequent).
Musculoskeletal and connective tissue disorders :
Muscle weakness and acceleration of cartilage degeneration.
GBOfficial regulatory label· Warnings and precautions· revised June 6, 2025[1]
2, and GI and cardiovascular risks below). 5) Cardiovascular and cerebrovascular effects Clinical trail and epidemiological data suggest that use of some NSAIDs (particularly at high doses and in long term treatment) may be associated with a small increased risk of arterial thrombotic events ( for example myocardial infarction or stroke).
There are insufficient data to exclude such a risk for Indometacin. Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and / or cerebrovascular disease should only be treated with Indometacin after careful consideration.
g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Indometacin should be used with caution in patients with psychiatric disorders, epilepsy, or Parkinsonism, as it may tend to aggravate these disorders. Gastro-intestinal disorders may be minimised by giving indometacin with food, milk or with an antacid.
If gastro-intestinal bleeding occurs, indometacin should be immediately discontinued. Indometacin may mask the signs and symptoms of infection, so antibiotic therapy should be initiated promptly if an infection occurs during therapy with indometacin.
It should be used cautiously in patients with existing but controlled infection. Caution is advised with concomitant use of live vaccines. In patients with rheumatoid arthiris, eye changes may occur which may be related to the underlying disease or to the therapy.
Therefore, in chronic rheumatoid disease, opthalmological examination at periodic intervals are recommended. Therapy should be discontinued if eye changes are observed for any unwanted effects on peripheral blood (anaemia), liver function or gastro-intestinal tract.
Cardiovascular, Renal and Hepatic Impairment:
The administration of NSAIDs may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at great risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics, the elderly, diabetes mellitus, extracellular volume depletion, congestive heart failure, sepsis, or concomitant use of any nephrotoxic drug.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised June 6, 2025[1]
• Active peptic ulcer; a recurrent history of gastro-intestinal lesions; in patients who have nasal polyps associated with angioneurotic oedema. • Safety for use in children has not been established. 1). g. asthma, rhinitis, angioedema or urticaria) in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs.
4-special warnings and precautions for use). 6-Pregnancy and lactation) • Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding). • History of upper gastrointestinal bleeding or perforation, related to previous NSAIDs therapy.
• Use with concomitant NSAIDs including cyclo oxygenase 2 specific inhibitors (See section
This is not medical advice. Consult a qualified healthcare professional.
Osteoarthritis TEVA-INDOMETHACIN should be used in those cases of severe osteoarthritis which do not respond to treatment with such other drugs as the salicylates. In many cases prompt relief of pain is obtained. Degenerative Joint Disease (Osteoarthritis) of the Hip TEVA-INDOMETHACIN has provided relief of pain and increased range of motion in patients with degenerative joint disease of the hip.
Gout In acute attacks of gout the response to TEVA-INDOMETHACIN is usually rapid and often dramatic. Marked reduction of pain may be obtained within 2 to 4 hours. Tenderness and heat subside within 24 to 36 hours, and swelling decreases over a 3 to 5 day period.
For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first. (See
How to take
CAOfficial regulatory label· revised March 22, 2025[2]
2 CONTRAINDICATIONS Indomethacin capsules are contraindicated in: the peri-operative setting of coronary artery bypass graft surgery (CABG). Although indomethacin has NOT been studied in this patient population, a selective COX-2 inhibitor NSAID studied in such a setting has led to an increased incidence of cardiovascular /thr om boe m bolic events, deep surgical infections and sternal wound complications.
during the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants severe uncontrolled heart failure known hypersensitivity to Indomethacin capsules or to any of the components/excipients.
For a complete listing, see
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]
1 Adverse Drug Reaction Overview The most common adverse reactions encountered with NSAIDs are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe. Fatalities have occurred on occasion, particularly in the elderly.
2 Clinical Trial Adverse Drug Reactions 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, TEVA-INDOMETHACIN Page 23 of 44 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.
) TEVA-INDOMETHACIN Page 25 of 44 Incidence >1% Incidence < 1% SPECIAL SENSES Tinnitus Ocular -corneal deposits and retinal disturbances including those of the macula, have been reported in some patients on prolong therapy with indomethacin.
Blurred vision, diplopia Hearing disturbances, deafness HEMATOLOGIC None Leukopenia Bone marrow depression Anemia secondary to obvious or occult gastrointestinal bleeding GENITOURINARY None Hematuria Vaginal bleeding Proteinuria Nephrotic syndrome Interstitial nephritis Aplastic anemia Hemolytic anemia Agranulocytosis Thrombocytopenic purpura Disseminated intravascular coagulation BUN elevation Renal insufficiency, including renal failure HYPERSENSITIVITY None Acute anaphylaxis Acute respiratory distress Rapid fall in blood pressure resembling a shock-like state Angioedema Dyspnea Asthma Purpura Angiitis Pulmonary edema METABOLIC None Edema Weight gain Fluid retention Flushing or sweating Hyperglycemia Glycosuria Hyperkalemia MISCELLANEOUS None Epistaxis Breast changes including enlargement and tenderness.
5 Post-Market Adverse Reactions Additional reports of serious adverse events temporally associated with TEVA -INDOMETHACIN during worldwide post-marketing experience are included below. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or clearly establish a causal relationship to TEVA -INDOMETHACIN exposure.
Cardiovascular Thrombophlebitis Hematologic TEVA-INDOMETHACIN Page 26 of 44 Leukemia TEVA-INDOMETHACIN Page 27 of 44 Genitourinary Urinary frequency Skin and Subcutaneous Tissue Disorders Photosensitivity reactions
CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]
1 Special Populations 02/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...............................................................
9 5 OVERDOSAGE........................................................................................................... 36 TEVA-INDOMETHACIN Page 4 of 44 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-INDOMETHACIN (indomethacin capsules) is indicated for the symptomatic treatment of the following: Rheumatoid Arthritis TEVA-INDOMETHACIN may be used singly or in combination with other agents.
However, it should not be used as a drug of first choice because of the adverse reactions that may occur with its use. Best results (relief of pain, tenderness, swelling and stiffness) have been obtained in the acute episodes of the disease.
However, in many patients with chronic rheumatoid arthritis, indomethacin produces a significant lessening of pain and stiffness within 48 hours. In other patients, treatment must be continued longer before significant subjective relief or objective evidence of decreased joint swelling and tenderness occur.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised March 22, 2025[2]
and 7 WARNINGS AND PRECAUTIONS) TEVA-INDOMETHACIN Page 5 of 44 Use of TEVA-INDOMETHACIN should be limited to the lowest effective dose for the shortest possible duration of treatment in order to minimize the potential risk for cardiovascular or gastrointestinal adverse events.
(See 2 CONTRAINDICATIONS and 7 WARNINGS AND PRECAUTIONS) TEVA-INDOMETHACIN, as a NSAID, does NOT treat clinical disease or prevent its progression. TEVA-INDOMETHACIN, as a NSAID, only relieves symptoms and decreases inflammation for as long as the patient continues to take it.
1 Pediatrics Pediatrics (< 18 years of age): Safety and efficacy have not been established in the pediatric population. In a few cases of severe juvenile rheumatoid arthritis, where TEVA-INDOMETHACIN was given along with other drugs, severe reactions, including fatalities, were reported.
2 Geriatrics Geriatrics (> 65 years of age): Evidence from clinical studies and postmarket experience suggests that use in the geriatric population is associated with differences in safety. 4 WARNINGS AND PRECAUTIONS, Geriatrics and
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised May 27, 2026[3]
2 DOSAGE AND ADMINISTRATION Use the lowest effective dosage for shortest duration consistent with individual patient treatment goals. 1 ) The dosage for moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis is indomethacin capsules 25 mg two or three times a day.
2 ) The dosage for acute painful shoulder (bursitis and/or tendinitis) is 75 to 150 mg daily in 3 or 4 divided doses. 3 ) The dosage for acute gouty arthritis is indomethacin capsules 50 mg three times a day. 1 General Dosing Instructions Carefully consider the potential benefits and risks of indomethacin capsules and other treatment options before deciding to use indomethacin capsules.
Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [ see Warnings and Precautions (5) ]. After observing the response to initial therapy with indomethacin, the dose and frequency should be adjusted to suit an individual patient’s needs.
Adverse reactions generally appear to correlate with the dose of indomethacin. Therefore, every effort should be made to determine the lowest effective dosage for the individual patient. 2 Moderate to severe rheumatoid arthritis including acute flares of chronic disease; moderate to severe ankylosing spondylitis; and moderate to severe osteoarthritis Indomethacin capsules 25 mg twice a day or three times a day.
If this is well tolerated, increase the daily dosage by 25 mg or by 50 mg, if required by continuing symptoms, at weekly intervals until a satisfactory response is obtained or until a total daily dose of 150 to 200 mg is reached. Doses above this amount generally do not increase the effectiveness of the drug.
In patients who have persistent night pain and/or morning stiffness, the giving of a large portion, up to a maximum of 100 mg, of the total daily dose at bedtime may be helpful in affording relief. The total daily dose should not exceed 200 mg.
In acute flares of chronic rheumatoid arthritis, it may be necessary to increase the dosage by 25 mg or, if required, by 50 mg daily. If minor adverse effects develop as the dosage is increased, reduce the dosage rapidly to a tolerated dose and observe the patient closely.
If severe adverse reactions occur, stop the drug. After the acute phase of the disease is under control, an attempt to reduce the daily dose should be made repeatedly until the patient is receiving the smallest effective dose or the drug is discontinued.
Careful instructions to, and observations of, the individual patient are essential to the prevention of serious, irreversible, including fatal, adverse reactions. 5) ]. 3 Acute painful shoulder (bursitis and/or tendinitis) Indomethacin capsules 75 to 150 mg daily in 3 or 4 divided doses.
The drug should be discontinued after the signs and symptoms of inflammation have been controlled for several days. The usual course of therapy is 7 to 14 days. 4 Acute Gouty Arthritis Indomethacin capsules 50 mg three times a day until pain is tolerable.
The dose should then be rapidly reduced to complete cessation of the drug. Definite relief of pain has been reported within 2 to 4 hours. Tenderness and heat usually subside in 24 to 36 hours, and swelling gradually disappears in 3 to 5 days.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 505 reports total. [4]
Off Label Use 140
Headache 102
Drug Intolerance 87
Drug Ineffective 86
Hypersensitivity 84
Angioedema 70
Drug Ineffective For Unapproved Indication 70
Swelling Face 69
Dysphonia 68
Swollen Tongue 66
Fatigue 48
Diarrhoea 46
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised May 27, 2026[3]
12 )] Most common adverse reactions (incidence ≥ 3%) are headache, dizziness, dyspepsia and nausea. gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving indomethacin capsules than in the group taking indomethacin suppositories or placebo. In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with indomethacin capsules or suppositories 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 capsules and these adverse reactions, some of which have been reported only rarely. The adverse reactions reported with indomethacin capsules may occur with use of the suppositories.
In addition, rectal irritation and tenesmus have been reported in patients who have received the capsules. 7%) dizziness* vertigo somnolence depression and fatigue (including malaise and listlessness) anxiety (includes nervousness) muscle weakness involuntary muscle movements insomnia muzziness psychic disturbances including psychotic episodes mental confusion drowsiness light-headedness syncope paresthesia aggravation of epilepsy and parkinsonism depersonalization coma peripheral neuropathy convulsion dysarthria SPECIAL SENSES tinnitus ocular-corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with indomethacin blurred vision diplopia hearing disturbances, deafness CARDIOVASCULAR None hypertension hypotension tachycardia chest pain congestive heart failure arrhythmia; palpitations METABOLIC None edema weight gain fluid retention flushing or sweating hyperglycemia glycosuria hyperkalemia INTEGUMENTARY none pruritus rash; urticaria petechiae or ecchymosis exfoliative dermatitis erythema nodosum loss of hair Stevens-Johnson syndrome erythema multiforme toxic epidermal necrolysis HEMATOLOGIC None leukopenia bone marrow depression anemia secondary to obvious or occult gastrointestinal bleeding aplastic anemia hemolytic anemia agranulocytosis thrombocytopenic purpura disseminated intravascular coagulation HYPERSENSITIVITY None acute anaphylaxis acute respiratory distress rapid fall in blood pressure resembling a shock-like state angioedema dyspnea asthma purpura angiitis pulmonary edema fever GENITOURINARY None hematuria vaginal bleeding proteinuria nephrotic syndrome interstitial nephritis BUN elevation renal insufficiency, including renal failure MISCELLANEOUS None epistaxis breast changes, including enlargement and tenderness, or gynecomastia * Reactions occurring in 3% to 9% of patients treated with indomethacin capsules.
) 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 Aβ hemolytic streptococcus , has been described in persons treated with nonsteroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome.
2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of indomethacin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Skin and Appendages:
Exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and fixed drug eruption (FDE).
USOfficial regulatory label· Warnings and precautions· revised May 27, 2026[3]
5 WARNINGS AND PRECAUTIONS Hepatotoxicity : Inform patients of warning signs and symptoms of hepatotoxicity. Discontinue if abnormal liver tests persist or worsen or if clinical signs and symptoms of liver disease develop. 3 ) Hypertension : Patients taking some antihypertensive medications may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure. 4 , 7 ) Heart Failure and Edema : Avoid use of indomethacin capsules in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure. 5 ) Renal Toxicity : Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of indomethacin capsules in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal function. 6 ) Anaphylactic Reactions : Seek emergency help if an anaphylactic reaction occurs.
7 ) Exacerbation of Asthma Related to Aspirin Sensitivity : Indomethacin capsules are contraindicated in patients with aspirin-sensitive asthma. Monitor patients with preexisting asthma (without aspirin sensitivity). 8 ) Serious Skin Reactions : Discontinue indomethacin capsules at first appearance of skin rash or other signs of hypersensitivity.
10 ) Fetal Toxicity : Limit use of NSAIDs, including indomethacin capsules, between about 20 to 30 weeks in pregnancy due to the risk of oligohydramnios/fetal renal dysfunction. 1 ) Hematologic Toxicity : Monitor hemoglobin or hematocrit in patients with any signs or symptoms of anemia.
1 Cardiovascular Thrombotic Events Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal.
Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease.
However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised May 27, 2026[3]
9) ] . History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. 8) ] . 1 )]. Known hypersensitivity to indomethacin or any components of the drug product. ( 4 ) History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
( 4 ) In the setting of CABG surgery. ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
3-Contraindication) Caution in patient with a history of hypertension and/or heart failure as fluid retention and oedema have been reported in association with NSAID therapy. Acute interstitial nephritis with haematuria, and occasionally nephritic syndrome has been reported in patients receiving long term administration of indometacin.
In patients, with a reduced renal blood flow where renal prostaglandins play a major role in maintaining renal perfusion, administration of a NSAID may precipitate overt renal decompensation. Indometacin should be given with caution and renal function should be monitored in any patient who may have reduced renal reserve, a lower daily dosage should be used to avoid excessive drug accumulation.
Discontinuation of indometacin is usually followed by recovery to the pre-treatment state. Increase in plasma potassium concentration, including hyperkalaemia, have been reported, even in some patients without renal impairment (attributed to hyporenin- anaemic hypo aldosteronism state).
2- Posology and administration) Respiratory disorders : Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients.
Caution is advised in patients with pre-existing sigmoid lesions (such as diverticulum or carcinoma) (or the development of these conditions) as indometacin can aggravate these conditions.
Gastrointestinal bleeding, ulceration and perforation:
GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events. When GI bleeding or ulceration occurs in patients receiving Indometacin, the treatment should be withdrawn.
3), and in the elderly. These patients should commence treatment on the lowest dose available. g. 5). Patients with a history of GI toxicity, particular when elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment.
5). 8 – Undersirable effects) Indometacin can inhibit platelet aggregation. The […]
In some cases of chronic rheumat oid arthritis, it may be necessary to continue treatment for at least a month before concluding that it has not produced significant benefit. Use of TEVA-INDOMETHACIN may enable reduction of […]
The increase in CV thrombotic risk has been observed most consistently at higher doses. To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible.
Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.
There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. 2) ]. Status Post Coronary Artery Bypass Graft (CABG) Surgery Two large, controlled clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10 to 14 days following CABG surgery found an increased incidence of myocardial infarction and stroke.
NSAIDs are contraindicated in the setting of CABG [ see Contraindications (4) ]. Post-MI Patients Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment.
In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.
Avoid the use of indomethacin capsules in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If indomethacin capsules are used in patients with a recent MI, monitor patients for signs of cardiac ischemia.
2 Gastrointestinal Bleeding, Ulceration, and Perforation NSAIDs, including indomethacin, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal.
These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients who develop a serious upper GI adverse event on NSAID therapy is symptomatic. Upper GI ulcers, gross bleeding, or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3 to 6 months, and in about 2% to 4% of patients treated for one year.
However, even short-term NSAID therapy is not without risk. Risk Factors for GI Bleeding, Ulceration, and Perforation Patients with a prior history of peptic ulcer disease and/or GI bleeding who used NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors.
Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy; concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking; use of alcohol; older age; and poor general health status.
Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.
Strategies to Minimize the GI Risks in NSAID-treated patients:
Use the lowest effective dosage for the shortest possible duration. Avoid administration of more than one NSAID at a time. Avoid use in patients at higher risk unless benefits are expected to outweigh the increased risk of bleeding. For such patients, as well as those with active GI bleeding, consider alternate therapies other than NSAIDs.
Remain alert for signs and symptoms of GI ulceration and bleeding during NSAID therapy. If a serious GI adverse event is suspected, promptly initiate evaluation and treatment, and discontinue indomethacin capsules until a serious GI adverse event is ruled out.
In the setting of concomitant use of low-dose aspirin for cardiac prophylaxis, monitor patients more closely for evidence of GI bleeding [ see Drug Interactions ( 7 ) ]. 3 Hepatotoxicity Elevations of ALT or AST (three or more times the upper limit of normal [ULN]) have been reported in approximately 1% of NSAID-treated patients in clinical trials.
In addition, rare, sometimes fatal, cases of severe hepatic injury, including fulminant hepatitis, liver necrosis, and hepatic failure have been reported. Elevations of ALT or AST (less than three times ULN) may occur in up to 15% of patients treated with NSAIDs including indomethacin.
, nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). ), discontinue indomethacin capsules immediately, and perform a clinical evaluation of the patient. 4 Hypertension NSAIDs, including indomethacin capsules, can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events.
Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazide diuretics, or loop diuretics may have impaired response to these therapies when taking NSAIDs [ see Drug Interactions (7) ]. Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.
5 Heart Failure and Edema The Coxib and traditional NSAID Trialists’ Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalizations for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients.
In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death. Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs.
, diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]) [ see Drug Interactions (7) ]. Avoid the use of indomethacin capsules in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure.
If indomethacin capsules are used in patients with severe heart failure, monitor patients for signs of worsening heart failure. 6 Renal Toxicity and Hyperkalemia Renal Toxicity Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.
Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation.
Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
No information is available from controlled clinical studies regarding the use of indomethacin capsules in patients with advanced renal disease. The renal effects of indomethacin capsules may hasten the progression of renal dysfunction in patients with preexisting renal disease.
Correct volume status in dehydrated or hypovolemic patients prior to initiating indomethacin capsules. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of indomethacin capsules [ see Drug Interactions (7) ] .
Avoid the use of indomethacin capsules in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If indomethacin capsules are used in patients with advanced renal disease, monitor patients for signs of worsening renal function.
It has been reported that the addition of the potassium-sparing diuretic, triamterene, to a maintenance schedule of indomethacin resulted in reversible acute renal failure in two of four healthy volunteers. Indomethacin and triamterene should not be administered together.
Hyperkalemia Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.
Both Indomethacin and potassium-sparing diuretics may be associated with increased serum potassium levels. The potential effects of indomethacin and potassium-sparing diuretics on potassium levels and renal function should be considered when these agents are administered concurrently.
8) ]. Seek emergency help if an anaphylactic reaction occurs. 8 Exacerbation of Asthma Related to Aspirin Sensitivity A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs.
Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, indomethacin capsules are contraindicated in patients with this form of aspirin sensitivity [ see Contraindications (4) ].
When indomethacin capsules are used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma. 9 Serious Skin Reactions NSAIDs, including indomethacin, can cause serious skin adverse reactions such as exfoliative dermatitis, Stevens - Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
NSAIDs can also cause fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions, and to discontinue the use of indomethacin capsules at the first appearance of skin rash or any other sign of hypersensitivity.
Indomethacin capsules are contraindicated in patients with previous serious skin reactions to NSAIDs [ see Contraindications (4) ]. 10 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported in patients taking NSAIDs such as indomethacin.
Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, lymphadenopathy, and/or facial swelling. Other clinical manifestations may include hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis.
Sometimes symptoms of DRESS may resemble an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its presentation, other organ systems not noted here may be involved. It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
If such signs or symptoms are present, discontinue indomethacin capsules and evaluate the patient immediately. 11 Fetal Toxicity Premature Closure of Fetal Ductus Arteriosus: Avoid use of NSAIDs, including indomethacin capsules, in pregnant women at about 30 weeks gestation and later.
NSAIDs, including indomethacin capsules, increase the risk of premature closure of the fetal ductus arteriosus at approximately this gestational age.
Oligohydramnios/Neonatal Renal Impairment:
Use of NSAIDs, including indomethacin capsules, at about 20 weeks gestation or later in pregnancy may cause fetal renal dysfunction leading to oligohydramnios and, in some cases, neonatal renal impairment. These adverse outcomes are seen, on average, after days to weeks of treatment, although oligohydramnios has been infrequently reported as soon as 48 hours after NSAID initiation.
Oligohydramnios is often, but not always, reversible with treatment discontinuation. Complications of prolonged oligohydramnios may, for example, include limb contractures and delayed lung maturation. In some postmarketing cases of impaired neonatal renal function, invasive procedures such as exchange transfusion or dialysis were required.
If NSAID treatment is necessary between about 20 weeks and 30 weeks gestation, limit indomethacin capsules use to the lowest effective dose and shortest duration possible. Consider ultrasound monitoring of amniotic fluid if indomethacin capsules treatment extends beyond 48 hours.
1 ) ]. 12 Hematologic Toxicity Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect on erythropoiesis. If a patient treated with indomethacin capsules has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.
NSAIDs, including indomethacin capsules, may increase the risk of bleeding events. , aspirin), serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding [ see Drug Interactions (7) ].
13 Masking of Inflammation and Fever The pharmacological activity of indomethacin capsules in reducing inflammation, and possibly fever, may diminish the utility of diagnostic signs in detecting infections. 6) ]. 15 Central Nervous System Effects Indomethacin capsules may aggravate depression or other psychiatric disturbances, epilepsy, and parkinsonism, and should be used with considerable caution in patients with these conditions.
Discontinue indomethacin capsules if severe CNS adverse reactions develop. Indomethacin capsules may cause drowsiness; therefore, caution patients about engaging in activities requiring mental alertness and motor coordination, such as driving a car.
Indomethacin may also cause headache. Headache which persists despite dosage reduction requires cessation of therapy with indomethacin capsules. 16 Ocular Effects Corneal deposits and retinal disturbances, including those of the macula, have been observed in some patients who had received prolonged therapy with indomethacin capsules.
Be alert to the possible association between the changes noted and indomethacin capsules. It is advisable to discontinue therapy if such changes are observed. Blurred vision may be a significant symptom and warrants a thorough ophthalmological examination.
Since these changes may be asymptomatic, ophthalmologic examination at periodic intervals is desirable in patients receiving prolonged therapy. Indomethacin capsules are not indicated for long-term treatment.