Tolectin Side Effects

Generic Name: tolmetin

Note: This page contains side effects data for the generic drug tolmetin. It is possible that some of the dosage forms included below may not apply to the brand name Tolectin.

It is possible that some side effects of Tolectin may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to tolmetin: oral capsule, oral tablet

As well as its needed effects, tolmetin (the active ingredient contained in Tolectin) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking tolmetin, check with your doctor immediately:

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 tolmetin side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned 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

Ulceration may occur with tolmetin (the active ingredient contained in Tolectin) 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.[Ref]

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.[Ref]

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) therapy is recommended in patients with liver disease.[Ref]

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.[Ref]

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.[Ref]

Hematologic

Hematologic side effects have included anemia and slight decreases in hemoglobin and hematocrit. Hemolytic anemia, agranulocytosis, thrombocytopenia, and granulocytopenia have been reported rarely.[Ref]

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.[Ref]

Renal

Proteinuria has been reported in a number of cases. However, tolmetin (the active ingredient contained in Tolectin) 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.[Ref]

Renal side effects have included elevated blood urea nitrogen, hematuria, and dysuria, nephrotic syndrome, and acute renal failure due to interstitial nephritis.[Ref]

Hypersensitivity

Numerous cases of anaphylactoid and anaphylactic reactions with tolmetin (the active ingredient contained in Tolectin) have been reported. In almost all of these cases, the reaction occurred after reinstitution of tolmetin therapy following an interruption in chronic administration.[Ref]

Hypersensitivity side effects have included rash, urticaria, drug fever, anaphylactoid reactions, and anaphylaxis. Tolmetin is contraindicated in patients with known hypersensitivity to zomepirac (Zomax).[Ref]

Dermatologic

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

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.[Ref]

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.[Ref]

References

1. "Product Information. Tolectin (tolmetin)." McNeil Pharmaceutical, Raritan, NJ.

2. Lanza FL, Nelson RS, Royer GL "Effects of ibuprofen, tolmetin and placebo on the gastric mucosa of aspirin-sensitive volunteers." Am J Gastroenterol 72 (1979): 528-34

3. Singh G, Ramey DR, Morfeld D, Fries JF "Comparative toxicity of non-steroidal anti-inflammatory agents." Pharmacol Ther 62 (1994): 175-91

4. Aylward M, Maddock J, Parker RJ, et al "Evaluation of tolmetin in the treatment of active chronic rheumatoid arthritis: open and controlled double-blind studies." Curr Med Res Opin 4 (1976): 158-69

5. Maibach E "European experiences with tolmetin in the treatment of rheumatic diseases." Curr Ther Res Clin Exp 19 (1976): 350-62

6. Cordrey LJ "Tolmetin sodium, a new arthritis drug: double-blind and long-term studies." J Am Geriatr Soc 24 (1976): 440-6

7. O'Brien WM "Long-term efficacy and safety of tolmetin sodium in treatment of geriatric patients with rheumatoid arthritis and osteoarthritis: a retrospective study." J Clin Pharmacol 23 (1983): 309-23

8. Sotsky SM, Tossell JW "Tolmetin induction of mania." Psychosomatics 25 (1984): 626-8

9. Ruppert GB, Barth WF "Tolmetin-induced aseptic meningitis." JAMA 245 (1981): 67-8

10. Sakai J, Joseph MW "Tolmetin and agranulocytosis." N Engl J Med 298 (1978): 1203

11. van Dijk BA, Rico PB, Hoitsma A, Kunst VA "Immune hemolytic anemia associated with tolmetin and suprofen." Transfusion 29 (1989): 638-41

12. Squires JE, Mintz PD, Clark S "Tolmetin-induced hemolysis." Transfusion 25 (1985): 410-3

13. Radford RG, Holley KE, Grande JP, Larson TS, Wagoner RD, Donadio JV, Mccarthy JT "Reversible membranous nephropathy associated with the use of nonsteroidal anti-inflammatory drugs." JAMA 276 (1996): 466-9

14. Tietjen DP "Recurrence and specificity of nephrotic syndrome due to tolmetin." Am J Med 87 (1989): 354-5

15. Feinfeld DA, Olesnicky L, Pirani CL, Appel GB "Nephrotic syndrome associated with use of the nonsteroidal anti-inflammatory drugs: case report and review of the literature." Nephron 37 (1984): 174-9

16. Pascoe MD, Gordon GD, Temple-Camp CR "Tolmetin-induced acute renal failure." S Afr Med J 70 (1986): 232-3

17. Perneger TV, Whelton PK, Klag MJ "Risk of kidney failure associated with the use of acetaminophen, aspirin, and nonsteroidal antiinflammatory drugs." N Engl J Med 331 (1994): 1675-9

18. Wellborne FR, Claypool RG, Copley JB "Nephrotic range pseudoproteinuria in a tolmetin-treated patient." Clin Nephrol 19 (1983): 211-2

19. Miller JL "Tolmetin sodium." Arthritis Rheum 20 (1977): 1033

20. Chatterjee GP "Nephrotic syndrome induced by tolmetin." JAMA 246 (1981): 1589

21. Katz SM, Capaldo R, Everts EA, DiGregorio JG "Tolmetin: association with reversible renal failure and acute interstitial nephritis." JAMA 246 (1981): 243-5

22. McCall CY, Cooper JW "Tolmetin anaphylactoid reaction." JAMA 243 (1980): 1263

23. Moore ME, Goldsmith DP "Nonsteroidal anti-inflammatory intolerance: an anaphylactic reaction to tolmetin." Arch Intern Med 140 (1980): 1105-6

24. Rake GW, Jacobs RL "Anaphylactoid reactions to tolmetin and zomepirac." Ann Allergy 50 (1983): 323-5

25. Restivo C, Paulus HE "Anaphylaxis from tolmetin." JAMA 240 (1978): 246

26. Brown JR, Weir AB Jr "Drug fever from tolmetin administration." JAMA 239 (1978): 24

27. Bretza JA, Novey HS "Anaphylactoid reactions to tolmetin after interrupted dosage." West J Med 143 (1985): 55-9

28. Ahmad S "Anaphylaxis from tolmetin." N Engl J Med 303 (1980): 1417

29. Gurwitz JH, Avron J, Bohn RL, Glynn RJ, Monane M, Mogun H "Initiation of antihypertensive treatment during nonsteroidal anti-inflammatory drug therapy." JAMA 272 (1994): 781-6

30. Johnson AG, Nguyen TV, Day RO "Do nonsteroidal anti-inflammatory drugs affect blood pressure? A meta-analysis." Ann Intern Med 121 (1994): 289-300

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