Etodolac Side Effects

Please note - some side effects for Etodolac may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Etodolac - for the Consumer

Etodolac

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Etodolac:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; stuffy nose; weakness.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Etodolac Extended-Release Tablets

All medicines can cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Etodolac Extended-Release Tablets:

Constipation; diarrhea; dizziness; gas; headache; heartburn; nausea; stomach upset; stuffy nose; weakness.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

Etodolac Side Effects - for the Professional

Etodolac

In patients taking Etodolac capsules and tablets, USP or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:

Gastrointestinal experiences including: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, gross bleeding/perforation, heartburn, nausea, GI ulcers (gastric/duodenal), vomiting.

Other events including: abnormal renal function, anemia, dizziness, edema, elevated liver enzymes, headaches, increased bleeding time, pruritis, rashes, tinnitus.

Adverse-reaction information for Etodolac was derived from 2,629 arthritic patients treated with Etodolac capsules and tablets in double-blind and open-label clinical trials of 4 to 320 weeks in duration and worldwide postmarketing surveillance studies. In clinical trials, most adverse reactions were mild and transient. The discontinuation rate in controlled clinical trials, because of adverse events, was up to 10% for patients treated with Etodolac.

New patient complaints (with an incidence greater than or equal to 1%) are listed below by body system. The incidences were determined from clinical trials involving 465 patients with osteoarthritis treated with 300 to 500 mg of Etodolac b.i.d. (i.e., 600 to 1000 mg/day).

Incidence Greater Than Or Equal To 1% - Probably Causally Related

Body as a whole - Chills and fever.
Digestive system - Dyspepsia (10%), abdominal pain1, diarrhea1, flatulence1, nausea1, abdominal distension, epigastric pain, abnormal stools, constipation, gastritis, melena, vomiting.
Nervous system - Asthenia/malaise1, dizziness1, depression, nervousness, fatigue.
Skin and appendages - Pruritus, rash.
Special senses - Blurred vision, tinnitus.
Urogenital system - Dysuria, urinary frequency.
Musculoskeletal—Arthralgia.

Drug-related patient complaints occurring in fewer than 3%, but more than 1%, are unmarked.

1

Drug-related patient complaints occurring in 3 to 9% of patients treated with Etodolac.

Incidence Less Than 1% - Probably Causally Related

(Adverse reactions reported only in worldwide postmarketing experience, not seen in clinical trials, are considered rarer and are italicized.)

Body as a whole - Allergic reaction, anaphylactic/anaphylactoid reactions (including shock).
Cardiovascular system - Hypertension, congestive heart failure, flushing, palpitations, syncope, vasculitis (including necrotizing and allergic).
Digestive system - Thirst, dry mouth, ulcerative stomatitis, anorexia, eructation, elevated liver enzymes, cholestatic hepatitis, hepatitis, cholestatic jaundice, duodenitis, jaundice, hepatic failure, liver necrosis, peptic ulcer with or without bleeding and/or perforation, intestinal ulceration, pancreatitis.
Hemic and lymphatic system - Ecchymosis, anemia, thrombocytopenia, bleeding time increased, agranulocytosis, hemolytic anemia, aplastic anemia, leukopenia, neutropenia, pancytopenia.
Metabolic and nutritional - Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.
Nervous system - Insomnia, somnolence.
Respiratory system - Asthma, pulmonary infiltration with eosinophilia.
Skin and appendages - Angioedema, sweating, urticaria, exfoliative dermatitis, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, leukocytoclastic vasculitis, hyperpigmentation, erythema multiforme.
Special senses - Photophobia, transient visual disturbances.
Urogenital system - Elevated BUN, renal failure, renal insufficiency, renal papillary necrosis.

Incidence Less Than 1% - Causal Relationship Unknown

(Medical events occurring under circumstances where causal relationship to Etodolac is uncertain. These reactions are listed as alerting information for physicians.)

Body as a whole - Infection, headache.
Cardiovascular system - Arrhythmias, myocardial infarction, cerebrovascular accident.
Digestive system - Esophagitis with or without stricture or cardiospasm, colitis, GI discomfort, burning sensation, blood in stools, gastralgia, upper abdominal discomfort.
Metabolic and nutritional - Change in weight.
Nervous system - Paresthesia, confusion, irritability.
Respiratory system - Bronchitis, bronchospasm, dyspnea, pharyngitis, rhinitis, sinusitis.
Skin and appendages - Alopecia, maculopapular rash, photosensitivity, skin peeling.
Special senses - Conjunctivitis, deafness, taste perversion, loss of taste.
Urogenital system - Cystitis, hematuria, leukorrhea, renal calculus, interstitial nephritis, uterine bleeding irregularities, renal impairment.
Musculoskeletal—Muscle pain.

Additional Adverse Reactions Reported with NSAIDs

Body as a whole - Sepsis, death
Cardiovascular system - Tachycardia
Digestive system - Gastric ulcers, gastritis, gastrointestinal bleeding, glossitis, hematemesis
Hemic and lymphatic system - Lymphadenopathy
Nervous system - Anxiety, dream abnormalities, convulsions, coma, hallucinations, meningitis, tremors, vertigo
Respiratory system - Respiratory depression, pneumonia
Urogenital system - Oliguria/polyuria, proteinuria

Etodolac Extended-Release Tablets

A total of 1552 patients were exposed to Etodolac extended-release tablets in controlled clinical studies of at least 4 weeks in length and using daily doses in the range of 400 to 1200 mg. In the tabulations below, adverse event rates are generally categorized based on the incidence of events in the first 30 days of treatment with Etodolac extended-release tablets. As with other NSAIDs, the cumulative adverse event rates may increase significantly over time with extended therapy.

In patients taking NSAIDs, including Etodolac extended-release tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are:

gastrointestinal experiences including:

other events including:

Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Etodolac Extended-Release Tablets Include

Body as a whole - allergic reaction, anaphylactic/anaphylactoid reactions (including shock), chills, fever, sepsis

Cardiovascular system - congestive heart failure, flushing, palpitations, tachycardia, syncope, vasculitis (including necrotizing and allergic)

Digestive system - anorexia, cholestatic hepatitis, cholestatic jaundice, dry mouth, duodenitis, eructation, esophagitis, gastritis, gastric/peptic ulcers, glossitis, hepatic failure, hepatitis, hematemesis, intestinal ulceration, jaundice, liver necrosis, melena, pancreatitis, rectal bleeding, stomatitis

Hemic and lymphatic system - agranulocytosis, ecchymosis, eosinophilia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, purpura, thrombocytopenia

Metabolic and nutritional - hyperglycemia in previously controlled diabetic patients

Nervous system - anxiety, confusion, depression, dream abnormalities, insomnia, nervousness, paresthesia, somnolence, tremors, vertigo

Respiratory system - asthma, dyspnea, pulmonary infiltration with eosinophilia

Skin and appendages - angioedema, cutaneous vasculitis with purpura, erythema multiforme, hyperpigmentation, sweating, urticaria, vesiculobullous rash

Special senses - blurred vision, photophobia, transient visual disturbances

Urogenital system - dysuria, elevated BUN, oliguria/polyuria, proteinuria, renal failure, renal insufficiency, renal papillary necrosis, serum creatinine increase, urinary frequency

Other NSAID Adverse Reactions, Which Occur Rarely Are

Body as a whole - anaphylactic reactions, appetite changes, death

Cardiovascular system - arrhythmia, cerebrovascular accident, hypotension, myocardial infarction

Digestive system - colitis, esophagitis with or without stricture or cardiospasm, thirst, ulcerative stomatitis

Hemic and lymphatic system - aplastic anemia, lymphadenopathy

Metabolic and nutritional - change in weight

Nervous system - coma, convulsions, hallucinations, meningitis

Respiratory - bronchitis, pneumonia, respiratory depression, sinusitis

Skin and appendages - alopecia, exfoliative dermatitis, maculopapular rash, photosensitivity, skin peeling, Stevens-Johnson syndrome, toxic epidermal necrosis

Special senses - conjunctivitis, deafness, hearing impairment, taste perversion

Urogenital system - cystitis, hematuria, interstitial nephritis, leukorrhea, renal calculus, uterine bleeding irregularities

Side Effects by Body System

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 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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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.

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