"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.
Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...
(Generic versions may still be available.)
Indocin Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Indocin (indomethacin) and Indocin, IV (indomethacin) for Injection Sterile is a nonsteroidal anti-inflammatory drug (NSAID) used to treat severe rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gouty arthritis, bursitis, and tendinitis. Indocin is available as a generic termed indomethacin. Common side effects of Indocin include GI symptoms (vomiting, diarrhea, and feeling of bowel fullness, constipation and rectal irritation), headache, and ringing in ears.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Indocin in Detail - Patient Information: Side Effects
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) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Indocin Overview - Patient Information: Side Effects
Upset stomach, heartburn, headache, drowsiness, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: swelling of the hands or feet (edema), sudden or unexplained weight gain, hearing changes (such as ringing in the ears), mental/mood changes, difficult/painful swallowing, unusual tiredness.
Get medical help right away if any of these rare but very serious side effects occur: change in the amount of urine, unexplained stiff neck.
This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including: dark urine, persistent nausea/vomiting/loss of appetite, severe stomach/abdominal pain, yellowing eyes or skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Indocin (Indomethacin)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Indocin FDA Prescribing Information: Side Effects
In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving Capsules INDOCIN (indomethacin) than in the group taking Suppositories INDOCIN (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 Capsules INDOCIN (indomethacin) was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
The adverse reactions for Capsules INDOCIN (indomethacin) 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 (indomethacin) and these adverse reactions, some of which have been reported only rarely.
The adverse reactions reported with Capsules INDOCIN (indomethacin) may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the suppositories.
The adverse reactions reported with Capsules INDOCIN (indomethacin) may also occur with use of the suspension.
|Incidence greater than 1%||Incidence less than 1%|
| nausea** with or without vomiting
dyspepsia** (including indigestion, heartburn and epigastric pain) diarrhea
abdominal distress or pain
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 pre-existing 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|
| headache (11.7%)
depression and fatigue
(including malaise and listlessness)
| anxiety (includes nervousness)
involuntary muscle movements
psychic disturbances including psychoticepisodes
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
hearing disturbances, deafness
|congestive heart failure
flushing or sweating
rash; urticaria petechiae or ecchymosis
| exfoliative dermatitis
loss of hair
toxic epidermal necrolysis
bone marrow depression
anemia secondary to obvious or occult gastrointestinal bleeding
disseminated intravascular coagulation
|none|| acute anaphylaxis
acute respiratory distress
rapid fall in blood pressure resembling a shock-like state
renal insufficiency, including renal failure
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 A β hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS, General).
Read the entire FDA prescribing information for Indocin (Indomethacin) »
Additional Indocin Information
Indocin - User Reviews
Indocin User Reviews
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Report Problems to the Food and Drug Administration
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