Indocine

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Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Indocine

Quick Facts

Property Description
Active Ingredient Indometacin (Indomethacin)
Pharmacological Class Nonsteroidal Anti-Inflammatory Drug (NSAID)
Common Use Relief of pain, inflammation, and fever
Origin Synthetic (Indole Acetic Acid Derivative)

What Type of Medicine is Indocine?

Indocine is a synthetic, prescription-only therapeutic agent whose active compound is Indometacin, also known as Indomethacin. Indometacin is classified as a Nonsteroidal Anti-Inflammatory Drug (NSAID). It belongs to a specific chemical group known as indole derivatives, or more precisely indole acetic acid derivatives. This places it in a distinctive chemical subclass among NSAIDs, a factor that is clinically recognized for contributing to its potent anti-inflammatory properties compared to some other NSAID subclasses.

What Forms Does Indometacin Come In?

Indometacin is manufactured as a single-active-ingredient product (monotherapy) and is distinguished by the breadth of its available dosage forms that allow for diverse routes of administration. These preparations include standard and extended-release capsules for oral use, an oral suspension (liquid), suppositories for rectal administration, and a sterile powder for injection for intravenous delivery. The availability of multiple non-oral forms is a differentiating factor for Indometacin. The medicine requires appropriate vehicles, such as a solid suppository base or a sterile diluent for the injection, alongside the active ingredient Indometacin.

What is Indocine's General Purpose?

The established purpose of Indocine, consistent with its classification, is to provide generalized relief by targeting the body’s inflammatory processes. Its mechanism of effect involves acting as a non-selective Cyclooxygenase inhibitor (COX inhibitor). By inhibiting the synthesis of prostaglandins, which are key chemical messengers for pain and inflammation, Indometacin simultaneously exerts potent anti-inflammatory, analgesic (pain-relieving), and antipyretic (fever-reducing) physiological actions. Indometacin is recognized for its efficacy in managing discomfort, confirming its established role as a powerful anti-inflammatory agent.

Regulatory References

  1. MedlinePlus

What side effects are possible with Indocine?

Possible Side Effects and Safety Information

The official safety profile for Indocine is structured around serious risks and specific adverse reactions documented in regulatory sources.


Serious Safety Warnings and Contraindications

Government health authorities include prominent warnings regarding the risk of serious, potentially fatal, Cardiovascular Thrombotic Events, including heart attack (myocardial infarction) and stroke, which may occur at any time during use and with increasing risk over longer duration. Indocine is contraindicated for treating pain right before or after coronary artery bypass graft (CABG) surgery.

There is also a warning for serious Gastrointestinal Adverse Events, including bleeding, ulceration, and perforation of the stomach or intestines, which can occur without warning symptoms. This risk may also increase with the duration of use.

Adverse Reactions by System and Frequency

Adverse reactions are classified based on incidence rates from clinical trials. The most frequently reported adverse reactions, occurring in 3% or more of patients, include headache, dizziness, upset stomach (dyspepsia), and nausea.

Safety data also documents potential toxicity to specific organ systems:

  • Hepatic Toxicity: Potential for elevated liver enzymes and severe liver injury.
  • Renal Toxicity: Risk of new or worsening kidney dysfunction, especially with prolonged use or in patients with pre-existing conditions.
  • Hematologic Toxicity: Possible blood disorders, including anemia and agranulocytosis.

Population-Specific Concerns

Official safety information cautions that older adults may be more sensitive to serious side effects like gastrointestinal bleeding and kidney problems. Use during the third trimester of pregnancy (starting around 20 weeks gestation) is associated with the risk of fetal kidney problems and premature closure of the fetal ductus arteriosus, leading to specific restrictions on its use during this period.

Overdose and Emergency Response

Overdose Manifestations and Severe Outcomes

Overdose with Indocine (Indometacin) can present with signs of systemic toxicity, primarily affecting the central nervous system (CNS) and gastrointestinal (GI) tract. Documented manifestations include headache, agitation, confusion, delirium, drowsiness, nausea, vomiting, stomach pain, and diarrhea. Physiological signs may include high or low blood pressure, increased heart rate, and diminished urine output, signaling potential renal involvement. Overdosage may rapidly progress to life-threatening outcomes such as seizures, coma, severe internal gastrointestinal bleeding, acute renal failure, or perforation. The elderly population is noted in regulatory documents as being more sensitive to these effects, with an increased risk of severe GI events and CNS complications.

Emergency Actions Required

Due to the absence of a specific pharmacological antidote, immediate action is mandated by regulatory authorities. Anyone suspected of having taken an overdose must seek medical help right away by contacting emergency services or a Poison Control Center. Urgent medical attention is required if the individual is exhibiting life-threatening symptoms or a decreased level of consciousness. Management is strictly symptomatic and supportive, and may involve procedures such as gastric lavage, administration of activated charcoal, intravenous fluids, and comprehensive hospital monitoring of vital signs, ECG, and renal status.

Therapeutic Uses of Indocine

What Indocine Treats: Main Uses and Benefits

Indocine (Indometacin) is a nonsteroidal anti-inflammatory drug (NSAID) applied in specific clinical contexts to address conditions marked by significant discomfort and functional strain. It is considered relevant for providing supportive relief across several therapeutic domains.

The medication is commonly used to help manage symptoms associated with chronic conditions like Rheumatoid Arthritis, Osteoarthritis, and Ankylosing Spondylitis, and is also relevant for acute episodes such as gouty arthritis, tendinitis, or bursitis. In these situations, it is used for managing symptom clusters of joint pain, stiffness, and swelling that create noticeable interference with daily stability. Beyond musculoskeletal applications, Indocine plays a role in managing symptoms related to systemic imbalance, such as fever associated with inflammatory conditions. It is also applied in a specialized capacity within neonatology to address Patent Ductus Arteriosus (PDA) in premature infants. The medication may provide support that helps ease the overall symptom burden, assisting with maintaining functional stability during symptomatic phases.


Therapeutic Summary: Symptomatic Domains

Domain Conditions Commonly Addressed
Chronic Rheumatoid Arthritis, Ankylosing Spondylitis
Acute Acute Gouty Arthritis, Bursitis, Tendinitis
Specialized Patent Ductus Arteriosus (PDA) in neonates

Eligibility and Restrictions for Use

Who can and cannot use Indocine?

Eligibility for Indocine (Indometacin) is strictly defined by regulatory guidelines to minimize serious health risks. Official labeling specifies which patient groups are permitted, restricted, or absolutely excluded from using this medicine.

Classification Population or Condition Regulatory Status
Contraindicated History of aspirin or NSAID-sensitive asthma Must not use
Contraindicated Pain management during CABG surgery Must not use
Contraindicated Third trimester of pregnancy (starting at 30 weeks) Must not use
Restricted Advanced renal disease or severe heart failure Avoid use; use only if benefits outweigh risks
Restricted Prior history of GI ulceration/bleeding Use with extreme caution
Not Established Children younger than 14 years (oral/rectal forms) Safety and efficacy not established

For adults, oral and rectal forms are generally indicated for treatment of labeled inflammatory conditions. The intravenous form is reserved for the specialized use of Patent Ductus Arteriosus in premature infants. Caution is also advised in older adults and patients with certain neurological conditions like epilepsy or Parkinson's disease, as the medicine may exacerbate these issues.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Indocine (Indometacin) is defined by officially documented patterns involving both pharmacokinetic and pharmacodynamic effects, as outlined in government regulatory information.

Official Interaction Statements

Co-administration with Diflunisal is not recommended as it is documented to increase the plasma concentration of Indometacin and decrease its renal clearance. Combining Indocine with analgesic doses of Aspirin or other NSAIDs is generally restricted due to the documented, increased risk of serious gastrointestinal adverse events, including bleeding and ulceration.

Pharmacokinetic Interactions officially include Indometacin reducing the elimination of co-administered drugs. This can lead to increased serum concentrations of substances like Lithium, Digoxin, and Methotrexate. For Methotrexate, this effect is documented as decreasing its tubular secretion, thereby potentiating toxicity. Probenecid is also documented to increase Indometacin's own plasma levels.

Pharmacodynamic Interactions involve Indocine reducing the therapeutic effectiveness of certain cardiovascular medications. It may diminish the antihypertensive effect of ACE Inhibitors, ARBs, and Beta-Blockers, and also reduce the natriuretic effect of Diuretics. Furthermore, the co-administration of Indocine with Anticoagulants (e.g., Warfarin) or antiplatelet agents (e.g., SSRIs) has an officially documented additive risk of bleeding and gastrointestinal adverse events.

Interaction severity involving ACE Inhibitors and ARBs is specifically noted in regulatory documents to potentially worsen renal function in the elderly, volume depleted, or those with renal impairment.

Mechanism of Action

Influence on the Eicosanoid Biosynthesis Pathway

The core mechanism involves the nonselective competitive inhibition of the Cyclooxygenase (COX) enzyme system, blocking both the COX-1 and COX-2 isoforms. This prevents the COX enzymes from converting their substrate, arachidonic acid, into prostaglandins and thromboxane. Indocine also functions as an inhibitor of Phospholipase A2 (PLA2), limiting the precursor needed for prostaglandin synthesis. The reduction of these mediators causes a decrease in localized vasodilation and vascular permeability.

Central and Peripheral Pathway Modulation

The mechanism influences the eicosanoid signaling pathway at multiple points. Peripherally, the reduction of Prostaglandin E2 (PGE2) decreases the sensitization of peripheral afferent nerve endings. Centrally, the inhibition of PGE2 synthesis occurs within the hypothalamus. This alters signaling within the hypothalamus, which influences the thermoregulatory set-point. Indocine further induces intracranial precapillary vasoconstriction, which causes a reduction in cerebral blood flow.

Dosage and Administration Information

Indocine (Indometacin) is available for oral, rectal, and intravenous administration, reflecting the drug's range of dosage forms including standard and extended-release capsules, suppositories, and a powder for injection. The fundamental principle of use for all forms is to utilize the lowest effective dosage for the shortest duration necessary for the condition being managed.

For oral use in adults, the immediate-release form is typically initiated at 25 mg two or three times daily. Dosage for chronic management of conditions like arthritis is adjusted incrementally, not exceeding a total daily dose of 150 mg to 200 mg in the immediate-release form. Extended-release capsules, available as a 75 mg strength, follow a simpler regimen, typically administered once or twice daily. Oral formulations are typically taken with food or milk to aid in gastrointestinal tolerability.

The duration of use is constrained by the nature of the condition; for acute episodes like painful shoulder (bursitis or tendinitis), treatment is typically discontinued after 7 to 14 days once symptoms are controlled. For nocturnal discomfort, a portion of the daily dose may be administered via a rectal suppository at bedtime. Specific handling is required for certain forms: for example, extended-release capsules must be swallowed whole and must not be chewed or crushed. Dosage for older adults is subject to additional caution, requiring the use of the lowest frequency and dose.

Recent Clinical Evidence

Evidence for Musculoskeletal and Acute Pain Conditions

The research base for Indocine in conditions characterized by chronic and acute inflammation involves established Randomized Controlled Trials (RCTs) and various clinical investigations. Studies were used in research exploring how symptoms change over time in adults with conditions like Rheumatoid Arthritis and Gouty Arthritis. The research focused on outcomes related to physical discomfort and functional imbalance, such as joint pain and morning stiffness. Research reports patterns observed in these studies during short time intervals. There is limited information for long-term outcomes regarding whether Indocine may influence disease progression; the evidence mainly contributes to understanding short-term symptom patterns.


Evidence for Specialized Neonatal Use (Patent Ductus Arteriosus)

The evidence supporting the specialized use of Indocine in evaluating Patent Ductus Arteriosus (PDA) in premature infants is derived from a distinct set of RCTs and authoritative systematic reviews. Researchers primarily monitored outcomes linked to the physiological process, with the key outcome measured being the rate of change in ductal physiology within a short period, and whether the infant subsequently was observed in need of surgical intervention. While research describes patterns related to the short-term physiological response, certainty remains low for long-term health markers.


Gaps and Uncertainties in the Research Record

A consistent theme in the research landscape is that long-term effects are not fully established for all uses. For chronic musculoskeletal use, the research does not determine whether an individual will respond similarly concerning disease progression. For the specialized neonatal use, certainty remains low for long-term developmental outcomes, an area where research is ongoing. Data for specific adult subgroups, such as older adults with comorbid conditions, are often derived from general surveillance, meaning the certainty level is variable for these groups.

Frequently Asked Questions (FAQ)

Common questions about Indocine (FAQ)

Q: Is Indocine considered a long-term or short-term treatment?

A: Regulatory guidance instructs that any use should involve the lowest effective dosage for the shortest duration necessary to manage the condition. For acute, temporary issues, treatment is typically short-term. For chronic conditions like arthritis, use is managed over time, with emphasis on continuous medical oversight.

Q: What are the most commonly reported side effects of Indocine?

A: According to official product information, the most frequently reported side effects, observed in 3% to 9% of patients, include headache, dizziness, upset stomach (dyspepsia), and nausea. Less common reactions that have also been reported include diarrhea and heartburn.

Q: Can Indocine be used by older adults (e.g., people over 65)?

A: Indocine is used in older adults. However, official warnings note that this population may be more sensitive to serious side effects. These include the potential for increased risks of gastrointestinal bleeding, kidney problems, and central nervous system effects like confusion.

Q: Can Indocine cause liver or kidney problems?

A: Yes, regulatory warnings highlight the potential for Indocine to affect both the liver and kidneys. The medication carries a risk of new or worsening kidney dysfunction (renal toxicity) and severe liver injury (hepatic toxicity). Individuals with pre-existing conditions or who are elderly may face the greatest risk, and periodic monitoring is often advised in regulatory guidance.

Q: What is the pregnancy safety classification for Indocine?

A: Official health agency information previously classified the drug as Pregnancy Category C during the first and second trimesters. Its use is strictly prohibited (contraindicated) starting at 30 weeks of pregnancy due to known risks of harm to the unborn baby's cardiovascular system.

Q: What is the typical duration of treatment with Indocine?

A: For acute, temporary inflammatory issues like bursitis, official documents typically recommend a treatment course of 7 to 14 days. For chronic conditions such as arthritis, the goal is always to limit use to the lowest effective dose for the shortest period of time needed to control symptoms.

Q: What happens if I miss a dose of Indocine?

A: Official patient information generally advises taking a missed dose as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Taking extra or double doses to make up for a missed one is not recommended.

Q: Does Indocine cause weight gain or weight loss?

A: Official adverse reaction data lists fluid retention (edema) and weight gain as reported side effects that occur in less than 1% of patients. Unusual weight gain, particularly if associated with swelling, is listed as a potential indicator of a serious side effect that should be reported.

Q: Is it normal to feel tired when first starting Indocine?

A: Regulatory documents list fatigue, which includes feelings of malaise or listlessness, and somnolence (drowsiness) as reported side effects. These effects are noted to be observed in some patients.

Q: Is Indocine known to interact with common over-the-counter pain relievers?

A: Regulatory documents restrict the use of Indocine with other NSAIDs or aspirin due to an increased risk of serious gastrointestinal events. While no formal drug interaction with acetaminophen (a common non-NSAID reliever) is documented, patients are advised to consult a healthcare provider before combining any pain products.

Q: Are there any mental health side effects associated with Indocine?

A: Yes. Less common, but reported, central nervous system side effects include mental confusion, anxiety, depression, and psychic disturbances, including psychotic episodes. Official warnings also note that Indocine may potentially worsen existing neurological conditions like epilepsy.

Q: Can Indocine affect blood pressure or heart rate?

A: Official warnings state that Indocine may cause the onset of new high blood pressure (hypertension) or worsen existing high blood pressure. Official guidance indicates that blood pressure should be monitored during treatment. Fluid retention is also a reported side effect.

Q: Is Indocine safe to take before surgery?

A: Indocine is strictly prohibited (contraindicated) immediately before or after coronary artery bypass graft (CABG) surgery due to heart risks. For all other types of surgery, a doctor must evaluate the risks of bleeding and cardiovascular events, as the drug can inhibit platelet aggregation.

Q: Does Indocine require regular blood tests or monitoring?

A: Official guidance indicates that if Indocine is used for an extended period, blood pressure should be monitored. Due to the potential for organ toxicity, periodic monitoring of kidney function, liver function, and blood cell counts may also be necessary.

Q: How quickly does Indocine leave the system once stopped?

A: Pharmacokinetic data from regulatory sources indicates that the mean elimination half-life of the medication in adults is approximately 4.5 hours. This figure represents the time it takes for half of the drug to be eliminated from the body.

Q: Why is Indocine sometimes prescribed for conditions other than its main use?

A: The official documentation strictly defines Indocine's labeled uses as specific forms of arthritis, acute gout, acute painful shoulder, and a specialized neonatal use for Patent Ductus Arteriosus. Any use outside of these specific, officially reviewed conditions is not described in official regulatory labeling.

Q: Does Indocine interact with alcohol?

A: Regulatory advisories note that consuming alcohol while taking Indocine is not advised. Alcohol consumption can significantly increase the risk of serious gastrointestinal adverse events, including bleeding and ulceration, associated with the medication.

Q: Can I take vitamins or supplements while using Indocine?

A: Official drug documents list interactions with specific prescription medicines, but they generally do not provide details on common vitamins or herbal supplements. Patients are advised to inform a healthcare provider about all products, including vitamins and supplements, being used before starting Indocine.

Q: What does the official patient information say about stopping Indocine suddenly?

A: Official patient guidance emphasizes that Indocine should never be stopped suddenly or without consulting a physician. Official guidance states that any change in the treatment regimen should be medically supervised and the medication should be taken exactly as prescribed.

Q: Can Indocine be taken by people who have a history of stomach problems?

A: Regulatory warnings indicate that patients with a prior history of gastrointestinal ulceration or bleeding have a significantly increased risk of developing a serious GI bleed while using Indocine. Regulatory warnings indicate that use requires extreme caution, and the medication may be avoided, in these cases.

Q: Is Indocine generally considered more potent than other drugs in its class?

A: Regulatory and scientific descriptions classify Indocine as a potent non-selective inhibitor of prostaglandin synthesis. This mechanism is responsible for its strong anti-inflammatory, fever-reducing, and pain-relieving effects.

Q: Does Indocine affect fertility or reproductive health?

A: For the class of medications that Indocine belongs to (NSAIDs), official warnings note that use may temporarily delay or prevent ovulation in some women. This effect is generally considered reversible after the medication is discontinued.

Q: Is Indocine known to cause dry mouth or changes in taste?

A: Dry mouth (xerostomia) and changes in taste are not listed among the most commonly reported side effects. However, dry mouth is included among the less common adverse reactions that regulatory documents note occur in less than 1% of patients.

Q: Does Indocine interact with birth control pills?

A: The official regulatory documents detailing drug interactions do not list a specific, formal interaction between Indocine and oral contraceptive pills (birth control pills). Patients should always inform their doctor about all hormonal medications they are using.

Q: What should be done if a severe allergic reaction to Indocine occurs?

A: Signs of a severe allergic reaction, such as a rash, difficulty breathing, or swelling of the face, require immediate emergency medical attention. Indocine should be stopped immediately if a severe reaction is suspected.

Q: What is the difference between Indocine and a similar generic version?

A: Indocine is the brand name (or trade name) for the medication. The generic version is Indometacin (or Indomethacin), which contains the exact same active ingredient and meets the same quality and effectiveness standards as the brand-name product.

Q: What is the specific age range for children or adolescents who can be prescribed Indocine?

A: For the oral and rectal forms, regulatory safety and efficacy have not been established for children younger than 14 years of age. Therefore, the use of these forms is not recommended for individuals under this age.

Q: How is the safety profile of Indocine generally described by regulators?

A: The safety profile is described as complex due to prominent warnings issued by health authorities regarding serious, potentially life-threatening side effects. These include the risk of cardiovascular events (like heart attack or stroke) and serious gastrointestinal adverse events (like bleeding or perforation).

Q: Does Indocine make you sensitive to the sun?

A: Official regulatory documents list various skin reactions, such as rash, as potential side effects. However, a specific warning for photosensitivity (increased sensitivity to the sun) is not listed in the key regulatory documents, though caution with sun exposure is generally advised for all NSAIDs.

Q: Are there any known long-term side effects after stopping Indocine?

A: The existing clinical research primarily focuses on the effects and safety of Indocine during the period of use. Long-term effects or side effects specifically occurring after the medication is completely discontinued are not well-established in the general patient population.

Q: Is it required to have a specific test before starting Indocine?

A: While regulatory labeling does not mandate testing for every patient, individuals with certain risk factors—such as pre-existing heart, liver, or kidney problems—may require testing before or during treatment to assess baseline organ function, which can be affected by the medication.

Q: Can Indocine affect sleep patterns?

A: Yes. Official reports indicate that central nervous system adverse reactions can include both insomnia (trouble sleeping) and somnolence (drowsiness). Patients should be aware of these potential effects on sleep patterns.

Q: How is the research on Indocine's effectiveness typically measured?

A: Effectiveness in conditions like arthritis is primarily measured by changes in clinical signs related to physical discomfort and functional imbalance. These signs include the intensity of joint pain, the degree of swelling, and the duration of morning stiffness over short time intervals.

Q: Can someone who is lactose intolerant take Indocine?

A: The official excipient list for the oral capsules indicates that they contain lactose monohydrate as an inactive ingredient. Individuals with known lactose intolerance are advised to consult with a doctor or pharmacist regarding this formulation detail.

Q: Are there any restrictions on driving or operating machinery while taking Indocine?

A: Since Indocine can cause central nervous system side effects such as dizziness, drowsiness, and confusion, patients are advised to avoid driving or operating hazardous machinery until they are aware of how the medication affects them.

How should Indocine be stored and disposed of?

Storage and Disposal Requirements

The required storage conditions for indomethacin (Indocin) are dependent upon its dosage form. It is a mandatory regulatory instruction that all forms must be stored out of the sight and reach of children.

Dosage Form Mandatory Temperature Condition
Oral Capsules Controlled Room Temperature (20 C to 25 C)
Oral Suspension Below 30 C, Do not freeze
Suppositories Refrigerated Conditions (2 C to 8 C)

All oral forms must be kept in a tightly closed container and stored away from excess heat, moisture, and direct light. Unused or expired medication must not be kept. Individuals should consult a healthcare professional or pharmacist for specific instructions on how to properly dispose of the product, following local regulations.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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