Etodolac Kobayashi Kako Side effects

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What are the possible side effects of Etodolac Kobayashi Kako?

Get emergency medical help if you have signs of an allergic reaction to Etodolac Kobayashi Kako: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

Stop using Etodolac Kobayashi Kako and call your doctor at once if you have:

Common Etodolac Kobayashi Kako side effects may include:

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.

Side effects of Etodolac Kobayashi Kako in details

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A total of 1552 patients were exposed to Etodolac Kobayashi Kako 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 Kobayashi Kako 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 Kobayashi Kako Extended-Release Tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: gastrointestinal experiences including:

*
Adverse events that were observed in < 1% of patients in the first 30 days of treatment with Etodolac Kobayashi Kako Extended-Release Tablets in clinical trials.
abdominal pain constipation diarrhea
dyspepsia flatulence GI ulcers (gastric/duodenal)*
gross bleeding/perforation* nausea vomiting
other events including:
abnormal renal function* anemia* asthenia
dizziness edema* elevated liver enzymes*
headaches hypertension increased bleeding time*
infection pharyngitis pruritus
rashes rhinitis tinnitus*

Additional NSAID Adverse Experiences Reported Occasionally with NSAIDs or Etodolac Kobayashi Kako 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

What is the most important information I should know about Etodolac Kobayashi Kako?

Etodolac Kobayashi Kako contraindications

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This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Etodolac Kobayashi Kako. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Etodolac Kobayashi Kako. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Etodolac Kobayashi Kako (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen.

Do not drink alcohol while taking Etodolac Kobayashi Kako. Alcohol can increase the risk of stomach bleeding caused by Etodolac Kobayashi Kako.

Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Etodolac Kobayashi Kako can make your skin more sensitive to sunlight and sunburn may result.


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References

  1. DailyMed. "ETODOLAC: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
  2. DTP/NCI. "Etodolic acid: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
  3. European Chemicals Agency - ECHA. "(RS)-2-(1,8-Diethyl-4,9-dihydro-3H-pyrano[3,4-b]indol-1-yl)acetic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology

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