Lodine XL Side Effects

Generic Name: etodolac

Note: This page contains information about the side effects of etodolac. Some of the dosage forms included on this document may not apply to the brand name Lodine XL.

Not all side effects for Lodine XL may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to etodolac: oral capsule, oral tablet, oral tablet extended release

In addition to its needed effects, some unwanted effects may be caused by etodolac (the active ingredient contained in Lodine XL). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking etodolac:

More common
  • Abdominal or stomach bloating, burning, cramping, or pain
  • belching
  • bloody or black, tarry stools
  • blurred vision
  • body aches or pain
  • cloudy urine
  • congestion
  • constipation
  • cough or hoarseness
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • dizziness
  • dryness or soreness of throat
  • feeling of indigestion
  • fever or chills
  • headache
  • increased bleeding time
  • itching skin
  • loss of appetite
  • lower back or side pain
  • nausea and vomiting
  • nervousness
  • pain in the chest below the breastbone
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • rash
  • runny nose
  • severe stomach pain
  • slow or fast heartbeat
  • swelling
  • tender, swollen glands in neck
  • trouble in swallowing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting of blood or material that looks like coffee grounds
  • weight loss
Symptoms of overdose
  • Agitation
  • change in consciousness
  • confusion
  • depression
  • difficult or troubled breathing
  • hives
  • hostility
  • irregular, fast or slow, or shallow breathing
  • irritability
  • loss of consciousness
  • muscle twitching
  • pain or discomfort in chest, upper stomach, or throat
  • pale or blue lips, fingernails, or skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • seizures
  • shortness of breath
  • sleepiness
  • stupor
  • swelling of face, ankles, or hands
  • tightness in chest
  • unusual drowsiness, dullness, or feeling of sluggishness
  • wheezing

Some of the side effects that can occur with etodolac may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Bloated, full feeling
  • continuing ringing or buzzing or other unexplained noise in ears
  • excess air or gas in stomach or intestines
  • hearing loss
  • lack or loss of strength
  • passing gas
  • sneezing
  • stuffy nose

For Healthcare Professionals

Applies to etodolac: oral capsule, oral tablet, oral tablet extended release

Gastrointestinal

Serious GI toxicity, such as inflammation, bleeding, ulceration, and perforation of the stomach, small intestine or large intestine, can occur at any time, with or without warning symptoms, in patients treated chronically with NSAIDs.

In one safety review, the overall incidence of serious GI side effects associated with etodolac (the active ingredient contained in Lodine XL) use ranged from 0.3% to 0.6%. The manufacturer cites a higher incidence, 2% to 4%, of serious GI events in patients treated with NSAIDs for up to one year.

Patients with a history of serious GI events or alcohol abuse are at increased risk for severe GI side effects.[Ref]

Gastrointestinal (GI) side effects have included dyspepsia (1% to 13%) and abdominal pain (3% to 11%). Heartburn, gastric ulcers (gastric/duodenal), GI bleeding/perforation, vomiting, nausea, diarrhea, and flatulence have been reported in 1% to 10% of patients. Melena, constipation, gastritis, abdominal distension, epigastric pain, and abnormal stools have been reported in greater than 1% and less than 3% of patients. Other side effects reported in less than 1% of patients have included GI discomfort, burning sensation, eructation, blood in stools, gastralgia, upper abdominal discomfort, thirst, dry mouth, intestinal ulceration, anorexia, duodenitis, and esophagitis with or without stricture or cardiospasm. More serious side effects reported in less than 1% of patients have included peptic ulcers with or without perforation, pancreatitis, and colitis. Gastritis, ulcerative stomatitis, and colonic strictures have been reported. In addition, glossitis, and hematemesis have also been reported with the use of NSAIDs.[Ref]

Renal

Renal side effects including renal impairment, elevations in serum creatinine and blood urea nitrogen, renal insufficiency, renal failure, renal papillary necrosis, interstitial nephritis, and renal calculi have been reported in less than 1% of patients. Abnormal renal function and proteinuria have been reported. Oliguria/polyuria has also been reported with the use of NSAIDs.[Ref]

Elevations in serum creatinine and blood urea nitrogen are typically minor and transient. However, in one safety review, abnormal renal function tests resulted in study withdrawal in 0.3% of patients treated with etodolac.

Etodolac may impair the ability of the kidney to cope with low renal blood flow states due to 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 etodolac-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.[Ref]

Hepatic

Hepatic side effects have included elevations in serum transaminases in up to 15% of patients. Hepatic failure, jaundice, cholestatic jaundice, elevated liver enzymes, hepatitis, and cholestatic hepatitis have been reported in less than 1% of patients.[Ref]

Elevations in serum transaminases three times normal values are reported in less than 1% of patients treated with etodolac. In one safety review, etodolac was discontinued in 0.9% of patients due to elevations in liver function tests.[Ref]

Hematologic

Hematologic side effects including anemia, thrombocytopenia, increased bleeding time, leukopenia, neutropenia, agranulocytosis, hemolytic anemia, pancytopenia, aplastic anemia, and ecchymosis have been reported in less than 1% of patients. Lymphadenopathy has also been reported with the use of NSAIDs.[Ref]

Dermatologic

Dermatologic side effects including pruritus and rash have been reported in greater than 1% and less than 3% of patients. Exfoliative dermatitis, leukocytoclastic vasculitis, sweating, alopecia, photosensitivity, skin peeling, hyperpigmentation, vesiculobullous rash, and maculopapular rash have been reported in less than 1% of patients.[Ref]

Hypersensitivity

Hypersensitivity side effects including urticaria, angioedema, cutaneous vasculitis with purpura, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, allergic reactions, anaphylactic/anaphylactoid reactions (including shock) have been reported in less in than 1% of patients. At least one case of hypersensitivity vasculitis mimicking temporal arteritis has also been reported.[Ref]

Metabolic

Metabolic side effects have been reported rarely. Hyperglycemia has been reported in previously in controlled diabetic patients (less than 1%), although causality is unknown. Change in weight has also been reported in less than 1% of patients.[Ref]

Nervous system

Nervous system side effects have included asthenia (2% to 9%), malaise (3% to 9%), headache (5%), and dizziness (3% to 9%). Fatigue and nervousness have been reported in greater than 1% and less than 3% of patients. Insomnia, somnolence, confusion, paresthesias, and irritability have been reported in less than 1% of patients. In addition, convulsions, coma, meningitis, tremors, vertigo, anxiety, dream abnormalities, and hallucinations have also been reported with the use of NSAIDs.[Ref]

Psychiatric

Psychiatric side effects have included depression (greater than 1% and less than 3%), insomnia, and somnolence. In addition, anxiety, dream abnormalities, and hallucinations have also been reported with the use of NSAIDs.[Ref]

Cardiovascular

Cardiovascular side effects have included worsening of heart failure and elevated blood pressure. Hypertension, edema, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic), arrhythmias, myocardial infarction, and cerebrovascular accident have been reported in less than 1% of patients. Tachycardia has also been reported with the use of NSAIDs.[Ref]

Genitourinary

Genitourinary side effects including dysuria and urinary frequency have been reported in greater than 1% and less than 3% of patients. Cystitis, hematuria, leukorrhea, and bleeding irregularities have been reported in less than 1% of patients. Intrauterine bleeding has also been reported.[Ref]

Ocular

Ocular side effects including blurred vision have been reported in greater than 1% and less than 3% of patients. Photophobia, transient visual disturbances, and conjunctivitis have been reported in less than 1% of patients.[Ref]

General

General side effects associated with the use of NSAIDs have included sepsis and death.[Ref]

Respiratory

Respiratory side effects have included pulmonary infiltration. Bronchitis, dyspnea, asthma, pharyngitis, eosinophilia, rhinitis, bronchospasm, and sinusitis have been reported in less than 1% of patients. Respiratory depression and pneumonia have also been reported with the use of NSAIDs.[Ref]

Musculoskeletal

Musculoskeletal side effects have included arthralgia (greater than 1% and less than 3%) and muscle pain (less than 1%).

Other

Other side effects including chills, fever, and tinnitus have been reported in greater than 1% and less than 3% of patients. Loss of taste, infection, and taste perversion have been reported in less than 1% of patients. Dysgeusia (altered taste) has also been reported.[Ref]

References

1. Schattenkirchner M "An updated safety profile of etodolac in several thousand patients." Eur J Rheumatol Inflamm 10 (1990): 56-65

2. Taha AS, McLaughlin S, Holland PJ, Kelly RW, Sturrock RD, Russell RI "Effect on gastric and duodenal mucosal prostaglandins of repeated intake of therapeutic doses of naproxen and etodolac in rheumatoid arthritis." Ann Rheum Dis 49 (1990): 354-8

3. van Eeden A, Schotborgh RH, Tytgat GN "An endoscopic evaluation of the effects of etodolac and diclofenac on the gastric and duodenal mucosa." Clin Ther 12 (1990): 496-502

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

5. Eis MJ, Watkins BM, Philip A, Welling RE "Nonsteroidal-induced benign strictures of the colon: a case report and review of the literature." Am J Gastroenterol 93 (1998): 120-1

6. Salom IL, Jacob G, Jallad N, Perdomo CA, Mullane JF, Weidler D "Gastrointestinal microbleeding associated with the use of etodolac, ibuprofen, indomethacin, and naproxen in normal males." J Clin Pharmacol 24 (1984): 240-6

7. Bianchi Porro G, Caruso I, Petrillo M, Montrone F, Ardizzone S "A double-blind gastroscopic evaluation of the effects of etodolac and naproxen on the gastrointestinal mucosa of rheumatic patients." J Intern Med 229 (1991): 5-8

8. Lanza F, Rack MF, Lynn M, Wolf J, Sanda M "An endoscopic comparison of the effects of etodolac, indomethacin, ibuprofen, naproxen, and placebo on the gastrointestinal mucosa." J Rheumatol 14 (1987): 338-41

9. Weideman RA, Kelly KC, Kazi S, et al. "Risks of clinically significant upper gastrointestinal events with etodolac and naproxen: A historical cohort analysis." Gastroenterology 127 (2004): 1322-8

10. "Product Information. Lodine (etodolac)." Wyeth-Ayerst Laboratories, Philadelphia, PA.

11. Wilcox GM, Porensky RS "Acute colitis associated with etodolac." J Clin Gastroenterol 25 (1997): 367-8

12. Shand DG, Epstein C, Kinberg-Calhoun J, et al "The effect of etodolac administration on renal function in patients with arthritis." J Clin Pharmacol 26 (1986): 269-74

13. Brater DC, Brown-Cartwright D, Anderson SA, Uaamnuichai M "Effect of high-dose etodolac on renal function." Clin Pharmacol Ther 42 (1987): 283-9

14. 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

15. Brater DC, Anderson SA, Brown-Cartwright D, Toto RD, Chen A, Jacob GB "Effect of etodolac in patients with moderate renal impairment compared with normal subjects." Clin Pharmacol Ther 38 (1985): 674-9

16. Mabee CL, Mabee SW, Baker PB, Kirkpatrick RB, Levine EJ "Fulminant hepatic failure associated with etodolac use." Am J Gastroenterol 90 (1995): 659-61

17. Cramer RL, Aboko-Cole VC, Gualtieri RJ "Agranulocytosis associated with etodolac." Ann Pharmacother 28 (1994): 458-60

18. Romano A, Pietrantonio F, Difonso M, Garcovich A, Chiarelli C, Venuti A, Barone C "Positivity of patch tests in cutaneous reaction to diclofenac - two case reports." Allergy 49 (1994): 57-9

19. Lie JT, Dixit RK "Nonsteroidal antiinflammatory drug induced hypersensitivity vasculitis clinically mimicking temporal arteritis." J Rheumatol 23 (1996): 183-5

20. 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

21. 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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