Etodolac Side Effects
Some side effects of etodolac 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 etodolac: oral capsule, oral tablet, oral tablet extended release
Along with its needed effects, etodolac 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 etodolac:More common
- Abdominal or stomach bloating, burning, cramping, or pain
- bloody or black, tarry stools
- blurred vision
- body aches or pain
- cloudy urine
- cough or hoarseness
- decrease in urine output or decrease in urine-concentrating ability
- dryness or soreness of throat
- feeling of indigestion
- fever or chills
- increased bleeding time
- itching skin
- loss of appetite
- lower back or side pain
- nausea and vomiting
- pain in the chest below the breastbone
- painful or difficult urination
- pale skin
- pounding in the ears
- runny nose
- severe stomach pain
- slow or fast heartbeat
- 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
- change in consciousness
- difficult or troubled breathing
- irregular, fast or slow, or shallow breathing
- 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
- shortness of breath
- swelling of face, ankles, or hands
- tightness in chest
- unusual drowsiness, dullness, or feeling of sluggishness
Some side effects of etodolac 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
- 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
- stuffy nose
For Healthcare Professionals
Applies to etodolac: oral capsule, oral tablet, oral tablet extended release
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 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
General side effects associated with the use of NSAIDs have included sepsis and death.
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.
Musculoskeletal side effects have included arthralgia (greater than 1% and less than 3%) and muscle pain (less than 1%).
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.
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