"Nov. 6, 2012 -- The FDA has approved Pfizer's Xeljanz (tofacitinib), a first-of-its-kind treatment for rheumatoid arthritis.
Xeljanz is approved for use by patients not helped by methotrexate, the usual first treatment for RA. It's a "...
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Lodine Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Lodine (etodolac) is a nonsteroidal ant-inflammatory drug (NSAID) used to treat osteoarthritis, rheumatoid arthritis, and acute pain. Lodine is available as a generic named etodolac. Common side effects of Lodine include GI symptoms (vomiting, diarrhea, or constipation), headache, dizziness, sore throat, and ringing in the ears.
Lodine is available in capsules at strengths of 200 and 300 mg, and as tablets at strengths of 400 and 500 mg. Usual dosage is 200-400 mg every 6 to 8 hours, not to exceed 1000 mg. Serious side effects of Lodine may include heart attack, stroke, coma, skin changes (paleness, blisters, rash, and hives), weight gain, swelling, shortness of breath, tachycardia, unusual bleeding (including GI bleeding), jaundice, stomach pain, and pain with urination, bloody urine, blurry vision, and back pain. Patients with asthma that are aspirin-sensitive should avoid use of this Lodine. Lodine may reduce the effectiveness of ACE inhibitors and increase lithium (Eskalith, Lithobid) levels; use with aspirin or similar agents is not recommended. Caution is advised as Lodine may react with a number of other drugs so the prescribing physician will need a list of current medications. Lodine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Lodine is excreted in human milk. Safety and effectiveness in pediatric patients below the age of 18 years have not been established for Lodine.
Our Lodine Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lodine in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking etodolac and seek medical attention or call your doctor at once if you have any of these serious side effects:
- chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
- black, bloody, or tarry stools;
- coughing up blood or vomit that looks like coffee grounds;
- swelling or rapid weight gain;
- urinating less than usual or not at all;
- nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- bruising, severe tingling, numbness, pain, muscle weakness; or
- fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).
Less serious side effects may include:
- upset stomach, mild heartburn or stomach pain, diarrhea, constipation;
- bloating, gas;
- dizziness, headache, nervousness;
- skin itching or rash;
- sore throat, stuffy nose;
- blurred vision; or
- ringing in your ears.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Lodine (Etodolac) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lodine FDA Prescribing Information: Side Effects
In patients taking Lodine (etodolac) or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1-10% of patients are:
Adverse-reaction information for Lodine (etodolac) was derived from 2,629 arthritic patients treated with Lodine (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 Lodine (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 Lodine (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.
Nervous system—Asthenia/malaise*, dizziness*, depression, nervousness.
Special senses—Blurred vision, tinnitus.
*Drug-related patient complaints occurring in 3 to 9% of patients treated with Lodine (etodolac) . Drug-related patient-complaints occurring in fewer than 3%, but more than 1%, are unmarked.
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.)
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.
Metabolic and nutritional—Edema, serum creatinine increase, hyperglycemia in previously controlled diabetic patients.
Skin and appendages—Angioedema, sweating, urticaria, vesiculobullous rash, cutaneous vasculitis with purpura, Stevens-Johnson Syndrome, toxic epidermal necrolysis, 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 Lodine (etodolac) is uncertain. These reactions are listed as alerting information for physicians.)
Body as a whole—Infection, headache.
Metabolic and nutritional—Change in weight.
Nervous system—Paresthesia, confusion.
Additional Adverse Reactions Reported with NSAIDS
Body as a whole—Sepsis, death
Hemic and lymphatic system—Lymphadenopathy
Respiratory system—Respiratory depression, pneumonia
Urogenital system—Oliguria/polyuria, proteinuria
Read the entire FDA prescribing information for Lodine (Etodolac) »
Additional Lodine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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