Tolectin 600 Side Effects
Generic name: tolmetin
Note: This document contains side effect information about tolmetin. Some of the dosage forms listed on this page may not apply to the brand name Tolectin 600.
Some side effects of Tolectin 600 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to tolmetin: oral capsule, oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking tolmetin (the active ingredient contained in Tolectin 600) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using tolmetin and 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;
bruising, severe tingling, numbness, pain, muscle weakness; or
fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects of tolmetin may include:
upset stomach, mild heartburn, diarrhea, constipation;
dizziness, headache, nervousness;
skin itching or rash;
blurred vision; or
ringing in your ears.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to tolmetin: oral capsule, oral tablet
Gastrointestinal side effects have been reported the most frequently. These have included nausea (11%), abdominal pain (3% to 9%), indigestion (3% to 9%), diarrhea (3% to 9%), constipation, and gastritis. More serious gastrointestinal side effects have included peptic ulceration (>1%), gastrointestinal perforation, and gastrointestinal hemorrhage.
Ulceration may occur with tolmetin therapy after as few as 7 days of therapy.
Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Tolmetin should be used with caution in these patients.
Gastrointestinal upset may be minimized by administering tolmetin with food or antacids.
Elevations in liver function tests three times normal values occur in less than 1% of patients.
Frequent monitoring of liver function tests during tolmetin (the active ingredient contained in Tolectin 600) therapy is recommended in patients with liver disease.
Hepatic side effects have included elevations in liver function tests, which may occur in up to 15% of patients. While such elevations are typically mild and transient, severe, sometimes fatal, hepatotoxicity has been reported.
Nervous system side effects have included headache, dizziness and depression. These side effects have been severe enough, in some cases, to warrant drug discontinuation. In addition, aseptic meningitis as well as mania have been reported.
Decreases in hemoglobin and hematocrit are generally mild and stabilize after the initial drop. These changes are thought to be due to sodium and water retention resulting in a dilutional effect and do not necessitate drug withdrawal.
Hematologic side effects have included anemia and slight decreases in hemoglobin and hematocrit. Hemolytic anemia, agranulocytosis, thrombocytopenia, and granulocytopenia have been reported rarely.
Proteinuria has been reported in a number of cases. However, tolmetin (the active ingredient contained in Tolectin 600) may produce a false positive test result (pseudoproteinuria) with the trichloroacetic acid (TCA) and sulfosalicylic acid (SSA) precipitation methods for determining urine protein. Patients who show protein in the urine should be tested using dye-impregnated urine reagent strips to verify results.
Development of renal failure is cause to discontinue tolmetin. In most cases the renal failure is reversible, although several cases have required management with either hemodialysis or peritoneal dialysis prior to resolution.
Tolmetin may impair the ability of the kidney to cope with low renal blood flow states due to its inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for tolmetin-induced renal insufficiency are advanced age and concomitant use of diuretics.
A case-control study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.
Patients with decreased renal function may be at increased risk for renal side effects.
Renal side effects have included elevated blood urea nitrogen, hematuria, and dysuria, nephrotic syndrome, and acute renal failure due to interstitial nephritis.
Numerous cases of anaphylactoid and anaphylactic reactions with tolmetin (the active ingredient contained in Tolectin 600) have been reported. In almost all of these cases, the reaction occurred after reinstitution of tolmetin therapy following an interruption in chronic administration.
Hypersensitivity side effects have included rash, urticaria, drug fever, anaphylactoid reactions, and anaphylaxis. Tolmetin is contraindicated in patients with known hypersensitivity to zomepirac (Zomax).
Dermatologic side effects have been reported rarely. These have included rash, purpura, erythema multiforme, and toxic epidermal necrolysis.
Cardiovascular side effects reported with other NSAIDs have included elevation of blood pressure, which may have clinical relevance in patients with other comorbid illnesses.
Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood-pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.
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