"(Reuters) - Sanofi SA and Regeneron Pharmaceuticals Inc on Friday said U.S. regulators had declined to approve their experimental treatment for rheumatoid arthritis because of manufacturing deficiencies.
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Lodine Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Lodine (etodolac) is a nonsteroidal anti-inflammatory drug (NSAID) used to treat osteoarthritis, rheumatoid arthritis, and acute pain. The brand name Lodine is no longer available in the U.S. Lodine is available as a generic. Common side effects of Lodine (etodolac) include:
- upset stomach,
- stomach pain,
- sore throat,
- stuffy nose,
- skin itching,
- blurred vision, and
- ringing in the ears.
Serious side effects of Lodine include:
- heart attack,
- skin changes;
- weight gain,
- shortness of breath,
- unusual bleeding (including GI bleeding),
- stomach pain, and
- pain with urination,
- bloody urine,
- blurry vision, and
- back pain.
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. 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 may interact with ACE inhibitors, aspirin or other NSAIDs, cyclosporine, digoxin, methotrexate, diuretics (water pills), lithium, phenylbutazone, antidepressants, steroids, and blood thinners. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Lodine; taking Lodine during the last 3 months of pregnancy may harm the fetus. Do not take Lodine during pregnancy unless your doctor has told you to. It is unknown if Lodine passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding. 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 etodolac or other NSAIDs, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are:
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 That or Equal to 1% - Probably Causally Related
Body as a whole - Chills and fever.
Skin and appendages - Pruritus, rash.
Special senses - Blurred vision, tinnitus.
Urogenital system - Dysuria, urinary frequency.
Drug-related patient complaints occurring in fewer than 3%, but more than 1%, are unmarked. 5*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).
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.
Nervous system - Insomnia, somnolence.
Respiratory system - Asthma, pulmonary infiltration with eosinophilia.
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 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.
Cardiovascular system - Tachycardia.
Hemic and lymphatic system - Lymphadenopathy.
Respiratory system - Respiratory depression, pneumonia.
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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