Side Effects of Tolectin (tolmetin)

Tolectin (tolmetin) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, as well as pain and inflammation that results from rheumatoid arthritis, juvenile arthritis, or osteoarthritis. NSAIDs are non-narcotic relievers of mild to moderate pain, reducing levels of prostaglandins responsible for pain, fever, and inflammation.

Tolectin blocks the enzyme that makes prostaglandins, resulting in lower concentrations. This reduces inflammation, pain, and fever. The brand name Tolectin is discontinued.

Common side effects of Tolectin include:

• gastrointestinal ulcerations,
• abdominal pain,
• cramping,
• nausea,
• gastritis,
• serious gastrointestinal bleeding,
• liver toxicity,
• stomach ulceration,
• black tarry stools, and
• weakness.

Serious side effects of Tolectin include:

• heart attacks,
• strokes,
• accumulation of fluid,
• increased chance of heart failure, and
• it may cause or worsen high blood pressure and kidney failure.

Drug interactions of Tolectin include blood thinning medications (anticoagulants) because of an increased risk of bleeding. It may also inhibit the elimination of lithium or methotrexate from the body, resulting in toxic blood levels. Side effects from cyclosporine may be increased by Tolectin. Tolmetin may reduce the effectiveness of antihypertensives. Combining Tolectin with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme (ACE) inhibitors in elderly, volume-depleted patients may cause reduced kidney function, including kidney failure. Consuming more than three alcoholic beverages per day while using Tolectin increases the risk of developing stomach ulcers.

Tolectin is generally avoided during pregnancy and should be used with caution by nursing mothers.

What are the important side effects of Tolectin (tolmetin)?

Most patients benefit from tolmetin and other NSAIDs with few side effects. However, serious side effects can occur, and generally tend to be dose-related. Therefore, it is advisable to use the lowest effective dose. The most common side effects of tolmetin involve the gastrointestinal system, and these include:

• ulcerations,
• abdominal pain,
• cramping,
• nausea,
• gastritis,
• serious gastrointestinal bleeding,
• liver toxicity,
• stomach ulceration,
• black tarry stools, and
• weakness.

Tolmetin should be avoided by patients with a history of asthma, hives, or other allergic reactions to aspirin or other NSAIDs. Rare but severe allergic reactions have been reported. It also should be avoided by patients with peptic ulcer disease or poor kidney function, as this medication can worsen both conditions.

Other important side effects include:

• heart attacks,
• strokes,
• accumulation of fluid, and
• increased chance of heart failure.

Tolmetin may cause or worsen high blood pressure and kidney failure.

Tolectin (tolmetin) side effects list for healthcare professionals

The adverse reactions observed in clinical trials with Tolectin (tolmetin sodium) include gastrointestinal complaints, most frequently. About 10% of patients dropped out because of adverse reactions, mainly gastrointestinal in nature.

Incidence Greater Than 1%

The following adverse reactions occurred more frequently than 1 in 100 in controlled clinical trials.

Gastrointestinal: Nausea (11%), dyspepsia,* gastrointestinal distress,* abdominal pain,* diarrhea,* flatulence,* vomiting,* constipation, gastritis, and peptic ulcer.

Body as a Whole: Headache, * asthenia, * chest pain

Central Nervous System: Dizziness, * drowsiness, depression

Dermatologic: Skin irritation

Special Senses: Tinnitus, visual disturbance

Hematologic: Small and transient decreases in hemoglobin and hematocrit not associated with gastrointestinal bleeding have occurred.

*Reactions occurring in 3% to 9% of patients treated with Tolectin (tolmetin sodium).

Incidence Less Than 1%

(Causal Relationship Probable)

The following adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing. The probability exists that there is a causal relationship between Tolectin (tolmetin sodium) and these adverse reactions.

Gastrointestinal: Gastrointestinal bleeding with or without evidence of peptic ulcer, perforation, glossitis, stomatitis, hepatitis, liver function abnormalities.

Body as a Whole: Anaphylactoid reactions, fever, lymphadenopathy, serum sickness

Hematologic: Hemolytic anemia, thrombocytopenia, granulocytopenia, agranulocytosis

Cardiovascular: Congestive heart failure in patients with marginal cardiac function.

Dermatologic: Urticaria, purpura, erythema multiforme, toxic epidermal necrolysis

Incidence Less Than 1%

(Causal Relationship Unknown)

Other adverse reactions were reported less frequently than 1 in 100 in controlled clinical trials or were reported since marketing, but a causal relationship between Tolectin (tolmetin sodium) and the reaction could not be determined. These rarely reported reactions are being listed as alerting information for the physician since the possibility of a causal relationship cannot be excluded.

Body as a Whole: Epistaxis

Special Senses: Optic neuropathy, retinal and macular changes

What drugs interact with Tolectin (tolmetin)?

ACE-inhibitors

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE-inhibitors, requiring consideration in patients taking both.

Aspirin

Concomitant administration of tolmetin sodium and aspirin is generally not recommended due to the potential increased adverse effects.

Diuretics

NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients, potentially leading to renal failure.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. Caution should be used when administering NSAIDs and lithium concomitantly.

Methotrexate

NSAIDs have been reported to competitively inhibit methotrexate accumulation in kidney slices. Caution should be used when administering NSAIDs and methotrexate concomitantly.

Warfarin

The effects of warfarin and NSAIDs on GI bleeding are synergistic, with a higher risk of bleeding for users of both drugs.

Tolmetin does not affect the binding of warfarin to human plasma proteins, but caution should be exercised when administering Tolmetin to patients on anticoagulants.

Hypoglycemic Agents

No change in the clinical effects of either Tolectin or hypoglycemic agents has been observed in adult diabetic patients under treatment with both medications.

Drug/Laboratory Test Interactions

The metabolites of tolmetin sodium in urine have been found to give positive tests for proteinuria using tests which rely on acid precipitation. No interference is seen in tests for proteinuria using dye-impregnated commercially available reagent strips.

Drug-Food Interactions

Administration of Tolectin with milk decreased total tolmetin bioavailability. When taken immediately after a meal, peak plasma tolmetin concentrations and total bioavailability were reduced.

Summary

Tolectin (tolmetin) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat fever, as well as pain and inflammation that results from rheumatoid arthritis, juvenile arthritis, or osteoarthritis. Common side effects of Tolectin include gastrointestinal ulcerations, abdominal pain, cramping, nausea, gastritis, serious gastrointestinal bleeding, liver toxicity, stomach ulceration, black tarry stools, and weakness. Tolectin is generally avoided during pregnancy. Tolectin is excreted in breast milk. Nursing mothers should decide whether to stop breastfeeding or stop Tolectin to avoid adverse effects in infants.