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Etodolac Side Effects

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
  • 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 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
  • sneezing
  • stuffy nose

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, Philadelphia, PA.

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

3. "Product Information. Etodolac ER (etodolac)." Taro Pharmaceuticals U.S.A. Inc, Hawthorne, NY.

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.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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