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Lodine XL Side Effects

Generic name: etodolac

Medically reviewed by Drugs.com. Last updated on Nov 29, 2021.

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

For the Consumer

Applies to etodolac: oral conventional capsules and tablets, oral extended-release tablets

Warning

    Cardiovascular Risk
  • Increased risk of serious (sometimes fatal) cardiovascular thrombotic events (e.g., MI, stroke).1 500 502 508 Risk may occur early in treatment and may increase with duration of use.500 502 505 506 508 (See Cardiovascular Thrombotic Effects under Cautions.)

  • Contraindicated in the setting of CABG surgery.508

    GI Risk
  • Increased risk of serious (sometimes fatal) GI events (e.g., bleeding, ulceration, perforation of the stomach or intestine).1 Serious GI events can occur at any time and may not be preceded by warning signs and symptoms.1 Geriatric individuals are at greater risk for serious GI events.1 (See GI Effects under Cautions.)

Side effects include:

Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, GI bleeding, GI perforation, nausea, peptic ulcer, vomiting, renal function abnormalities, anemia, dizziness, edema, liver function test abnormalities, headache, prolonged bleeding time, pruritus, rash, tinnitus.

For Healthcare Professionals

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

General

The most frequently reported side effects were gastrointestinal in nature and included dyspepsia, abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric ulcers, duodenal ulcers, and vomiting.[Ref]

Gastrointestinal

Very common (10% or more): Dyspepsia (10%)

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, gastric ulcer, duodenal ulcer, vomiting, abdominal distention, epigastric pain, stools abnormal, gastritis, melena

Very rare (less than 0.01%): Pancreatitis

Frequency not reported: Dry mouth, ulcerative stomatitis, eructation, peptic ulcer, gastrointestinal (GI) bleeding, perforation, esophagitis, esophageal stricture, cardiospasm, colitis, GI discomfort, burning sensation, gastralgia, upper abdominal discomfort, glossitis, hematemesis, rectal bleeding, heartburn, indigestion, ulcerative colitis exacerbated, Crohn's disease exacerbated

Postmarketing reports: Intestinal ulceration[Ref]

Cardiovascular

Frequency not reported: Hypertension, congestive heart failure, flushing, palpitations, arrhythmia, myocardial infarction, tachycardia, cardiac failure

Postmarketing reports: Necrotizing vasculitis[Ref]

Renal

Common (1% to 10%): Renal function abnormal

Frequency not reported: Renal calculus, interstitial nephritis, renal impairment, nephrotoxicity, nephrotic syndrome, renal failure

Postmarketing reports: Renal insufficiency, renal papillary necrosis[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache

Frequency not reported: Syncope, somnolence, cerebrovascular accident, paresthesia, taste perversion, loss of taste, convulsion, coma, tremor, drowsiness, optic neuritis, stroke[Ref]

Dermatologic

Common (1% to 10%): Pruritus, rash

Very rare (less than 0.01%): Stevens-Johnson Syndrome, toxic epidermal necrolysis

Frequency not reported: Ecchymosis, angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, hyperpigmentation, alopecia, maculopapular rash, photosensitivity, skin peeling, purpura, erythema multiforme

Postmarketing reports: Allergic vasculitis, cutaneous vasculitis, leukocytoclastic vasculitis[Ref]

Hepatic

Common (1% to 10%): Liver enzymes increased

Frequency not reported: Bilirubinuria, hepatitis, jaundice

Postmarketing reports: Cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, hepatic failure, liver necrosis, fatal fulminant hepatitis[Ref]

Hematologic

Common (1% to 10%): Anemia, bleeding time increased

Frequency not reported: Thrombocytopenia, lymphadenopathy, neutropenia, agranulocytosis, hemolytic anemia, aplastic anemia, pancytopenia, leukopenia[Ref]

Metabolic

Frequency not reported: Anorexia

Postmarketing reports: Hyperglycemia[Ref]

Psychiatric

Common (1% to 10%): Depression, nervousness

Frequency not reported: Insomnia, confusion, anxiety, dreams abnormal, hallucination, disorientation[Ref]

Genitourinary

Common (1% to 10%): Dysuria, urinary frequency

Frequency not reported: Cystitis, hematuria, leukorrhea, uterine bleeding irregular, oliguria, polyuria, proteinuria[Ref]

Ocular

Common (1% to 10%): Vision blurred

Frequency not reported: Photophobia, transient visual disturbance, conjunctivitis[Ref]

Respiratory

Frequency not reported: Asthma/aggravated asthma, bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis, respiratory depression, pneumonia

Postmarketing reports: Pulmonary infiltration eosinophilic[Ref]

Musculoskeletal

Common (1% to 10%): Arthralgia

Frequency not reported: Muscle pain[Ref]

Other

Common (1% to 10%): Edema, tinnitus, fever, chills, asthenia, malaise, fatigue

Frequency not reported: Serum creatinine increased, infection, weight abnormal, irritability, deafness, meningitis, vertigo, sepsis, death, weakness, aseptic meningitis

Postmarketing reports: Thirst, BUN increased[Ref]

Immunologic

Frequency not reported: Allergic/hypersensitivity reaction, anaphylactic/anaphylactoid reaction[Ref]

References

1. "Product Information. Lodine (etodolac)." Wyeth-Ayerst Laboratories (2001):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. "Product Information. Etodolac ER (etodolac)." Taro Pharmaceuticals U.S.A. Inc (2016):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.