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

Along with its needed effects, tolmetin (the active ingredient contained in Tolectin 600) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking tolmetin:

More common
  • Abdominal or stomach pain
  • diarrhea
  • dizziness
  • headache
  • nausea
  • numbness or tingling in the arms or legs
  • swelling
  • trouble thinking, speaking, or walking
  • vomiting
  • weakness
  • weight gain
Less common
  • Black, tarry stools
  • bladder pain
  • blood in the vomit
  • bloody or cloudy urine
  • blurred or loss of vision
  • burning feeling in the chest or stomach
  • burning, itching, redness, or stinging of the skin
  • chest pain
  • difficult, burning, or painful urination
  • disturbed color perception
  • double vision
  • frequent urge to urinate
  • halos around lights
  • indigestion
  • lower back or side pain
  • night blindness
  • overbright appearance of lights
  • severe or continuing stomach pain
  • stomach upset
  • tenderness in the stomach area
  • tunnel vision
Rare
  • Back or leg pains
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • chills
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • difficulty with breathing
  • difficulty with swallowing
  • dilated neck veins
  • extreme fatigue
  • fast, irregular heartbeat
  • feeling of discomfort
  • fever
  • general body swelling
  • heartburn
  • hives or welts
  • increased thirst
  • inflammation of the joints
  • irregular breathing
  • joint or muscle pain
  • light-colored stools
  • loss of appetite
  • muscle aches
  • nosebleeds
  • pale skin
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • severe and continuing nausea
  • shortness of breath
  • skin rash
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, feet, or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • trouble with breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • upper right abdominal pain
  • wheezing
  • yellow eyes and skin

Some side effects of tolmetin may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Acid or sour stomach
  • belching
  • bloated full feeling
  • excess air or gas in the stomach or intestines
  • lack or loss of strength
  • passing gas
  • stomach discomfort
  • weight loss
Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • discouragement
  • feeling sad or empty
  • hearing loss
  • irritability
  • loss of interest or pleasure
  • sleepiness
  • tiredness
  • trouble with concentrating
  • trouble with sleeping
Rare
  • Redness, swelling, or soreness of the tongue
  • swelling or inflammation of the mouth

For Healthcare Professionals

Applies to tolmetin: oral capsule, oral tablet

Gastrointestinal

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.

Hepatic

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

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.

Hematologic

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.

Renal

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.

Hypersensitivity

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

Dermatologic side effects have been reported rarely. These have included rash, purpura, erythema multiforme, and toxic epidermal necrolysis.

Cardiovascular

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

Hide
(web5)