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Indocin Oral Suspension

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Indocin Oral Suspension

Indocin Oral Suspension 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 Oral Suspension 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 Oral Suspension (Indomethacin Oral Suspension) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Indocin Oral Suspension FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The adverse reactions for Capsules INDOCIN 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 Capsules INDOCIN may also occur with use of the suspension.

Incidence greater than 1% Incidence less than 1%  
GASTROINTESTINAL
nausea * with or without vomiting dyspepsia* (including indigestion, heartburn and epigastric pain) diarrhea anorexia bloating (includes distension) flatulence peptic ulcer gastroenteritis rectal bleeding proctitis gastrointestinal bleeding without obvious ulcer formation and perforation of pre-existing sigmoid lesions (diverticulum, carcinoma, etc.) development of ulcerative colitis and regional ileitis
abdominal distress or pain constipation 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 ulcerative stomatitis toxic hepatitis and jaundice (some fatal cases have been reported) intestinal strictures (diaphragms)
CENTRAL NERVOUS SYSTEM
headache (11.7%) 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 INDOCIN 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 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:

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 non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS, General).

Read the entire FDA prescribing information for Indocin Oral Suspension (Indomethacin Oral Suspension) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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