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Posted by Bob P ( on July 20, 2000 at 16:54:37:

In Reply to: Okay guys - help on Indocin posted by Trudy on July 20, 2000 at 13:15:07:

Looks like kidney damage, GI bleeding, hypertension are the main ones. You'll have to look up the big words. I don't know what half this stuff means.
Bob P

Adverse Reactions

Intraventricular hemorrhage has occurred in neonates receiving indomethacin. Although indomethacin does transiently inhibit
platelet aggregation, intraventricular hemorrhage also occurs in neonates not receiving indomethacin.

Renal dysfunction can occur during therapy with NSAIDs including indomethacin. Most commonly, azotemia occurs, although
other renal syndromes such as renal papillary necrosis, nephrotic syndrome, hematuria, proteinuria, and interstitial nephritis are
possible. Onset is usually within several days after beginning therapy and is frequently reversible. Patients at risk include the
elderly, patients with congestive heart failure, patients receiving loop diuretics or triamterene, and those with moderate to severe
preexisting renal impairment. Hyperkalemia and hyperuricemia can also be a manifestation of renal insufficiency.

Gastritis, GI bleeding, and ulceration are all possible complications of therapy with indomethacin and can be serious.
Preexisting gastric or intestinal lesions can be reactivated by indomethacin, which can result in hemorrhage. Patients should be
advised of the signs and symptoms, although there is a poor correlation between symptoms and degree of GI injury. While
misoprostil has been approved for use in the prevention of NSAID-induced gastritis, it is not universally effective. Patients at
risk for serious adverse GI effects include the elderly, patients receiving corticosteroids concomitantly, and those with a previous
history of gastrointestinal events. Relatively minor adverse reactions, such as nausea/vomiting, abdominal pain, diarrhea, or
constipation can be lessened by administration of the oral dose with or immediately after food, or with antacids.

Adverse hematologic effects occur in fewer than 1% of patients receiving indomethacin, but because of their potential severity,
blood counts should be monitored periodically. Possible manifestations include hemolysis with anemia, aplastic anemia,
pancytopenia, agranulocytosis, and thrombocytopenia.

Various nervous system adverse effects, mainly headache, somnolence, and dizziness, are attributed to indomethacin. Headache
is more common in the morning and can be severe. Adverse nervous system effects may be dose-related, but if severe reactions
persist, indomethacin should be discontinued.

Spontaneous hypertension can occur with indomethacin therapy. In addition, indomethacin can interfere with the mechanism
and/or actions of some antihypertensive agents including captopril, thiazide diuretics, and beta-adrenergic blocking agents (see
Drug Interactions).

Retinopathy of prematurity (retrolental fibroplasia) has occurred in neonates receiving indomethacin. This condition also occurs
in neonates not receiving indomethacin. Other ophthalmic toxicity, including blurred vision, intraepithelial corneal deposits, and
corneal and retinal disturbance, has been reported in fewer than 1% of patients. Other adverse reactions of the special senses
include tinnitus.

Maculopapular rash and urticaria have been reported in 13% of patients taking NSAIDs. Other dermatologic reactions occur
less frequently, including bullous rash, toxic epidermal necrolysis, and vasculitis

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