Medical Editor: John P. Cunha, DO, FACOEP
Indocin (indomethacin) and Indocin IV (indomethacin) for Injection is a nonsteroidal anti-inflammatory drug (NSAID) used to treat severe rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gouty arthritis, bursitis, and tendinitis. The brand name Indocin is no longer available in the U.S. but may be available as a generic termed indomethacin. Common side effects of Indocin (indomethacin) and Indocin IV (indomethacin) for Injection include:
- upset stomach,
- a feeling of bowel fullness,
- rectal irritation,
- skin rash,
- itching, or
- blurred vision.
Indocin is available in capsules in strengths of 25 and 50 mg, in suspension strength of 25 mg per 5 ml and as a suppository in strength of 50 mg per suppository. Initial doses usually start at 25 mg three times daily. Indocin IV (indomethacin) for Injection Sterile Vial contains 1 mg Indocin and is used by specialists in infants to close a patent ductus arteriosus in the heart and is not commonly prescribed. Indocin (indomethacin) ordinarily should not be prescribed for pediatric patients under 15 years old. In late pregnancy, Indocin (indomethacin and other NSAIDs) should be avoided because it may cause premature closure of the ductus arteriosus. Serious side effects of Indocin may include heart attack, stroke, skin changes (paleness, blisters, rash, and hives), weight gain, swelling, shortness of breath, tachycardia, unusual bleeding (including GI bleeding), jaundice, stomach pain, and pain with urination, bloody urine, blurry vision, and back pain. Patients with asthma that are aspirin-sensitive should avoid use of this drug. Indocin may reduce the effectiveness of ACE inhibitors and increase lithium (Eskalith, Lithobid) levels; use with aspirin or similar agents is not recommended. Caution is advised as Indocin may react with a number of other drugs so the prescribing physician will need a list of current medications. Indocin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and infant; it is not recommended for use in breastfeeding women.
Our Indocin and Indocin, IV (indomethacin) for Injection Sterile Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- urinating less than usual or not at all;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
- bruising, severe tingling, numbness, pain, muscle weakness.
Less serious side effects may include:
- upset stomach, mild heartburn, diarrhea, constipation;
- bloating, gas;
- dizziness, nervousness, headache;
- skin rash, itching;
- blurred vision; or
- ringing in your ears.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Indocin (Indomethacin)
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
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 INDOCIN Capsules than in the group taking INDOCIN 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 INDOCIN Suppositories or Capsules was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
The adverse reactions for INDOCIN 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 INDOCIN and these adverse reactions, some of which have been reported only rarely.
The adverse reactions reported with INDOCIN Capsules may also occur with use of the suspension.
Table 1 : Summary of Adverse Reactions for INDOCIN
|Incidence greater than 1 %||Incidence less than 1%|
|nausea* with or without vomiting
dyspepsia* (including indigestion, heartburn and epigastric pain)
abdominal distress or pain
bloating (includes distension)
single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small and large intestines
intestinal ulceration associated with stenosis and obstruction
|gastrointestinal bleeding without obvious ulcer formation and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.)
development of ulcerative colitis and regional ileitis
toxic hepatitis and jaundice (some fatal cases have been reported) intestinal strictures (diaphragms)
|CENTRAL NERVOUS SYSTEM|
depression and fatigue (including malaise and listlessness)
|anxiety (includes nervousness)
involuntary muscle movements
psychic disturbances including psychotic episodes
mental confusion drowsiness
aggravation of epilepsy and parkinsonism
|tinnitus||ocular — corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with INDOCIN||blurred vision
|congestive heart failure
flushing or sweating
|none||pruritus rash; urticaria petechiae or ecchymosis||exfoliative dermatitis
loss of hair
toxic epidermal necrolysis
|None||leukopenia bone marrow depression anemia secondary to obvious or occult gastrointestinal bleeding||aplastic anemia
disseminated intravascular coagulation
acute respiratory distress
rapid fall in blood pressure resembling a shock-like state
|BUN elevation renal insufficiency, including renal failure|
|None||epistaxis breast changes, including enlargement and tenderness, or gynecomastia|
|*Reactions occurring in 3% to 9% of patients treated with INDOCIN. (Those reactions occurring in less than 3% of the patients are unmarked.)|
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:
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
Read the entire FDA prescribing information for Indocin (Indomethacin)
© Indocin Patient Information is supplied by Cerner Multum, Inc. and Indocin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.