What are the possible side effects of Etopen?
Get emergency medical help if you have signs of an allergic reaction to Etopen: 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 Etopen and call your doctor at once if you have:
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changes in your vision;
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the first sign of any skin rash, no matter how mild;
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shortness of breath (even with mild exertion);
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swelling or rapid weight gain;
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signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
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liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
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kidney problems - little or no urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
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low red blood cells (anemia) - pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
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severe skin reaction - fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.
Common Etopen side effects may include:
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nausea, vomiting, stomach pain, indigestion;
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diarrhea, constipation, gas;
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dizziness, weakness;
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sore throat, runny nose, flu symptoms;
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itching, rash; or
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headache.
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 Etopen in details
A total of 1552 patients were exposed to Etopen 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 Etopen 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 Etopen Extended-Release Tablets, the most frequently reported adverse experiences occurring in approximately 1 to 10% of patients are: gastrointestinal experiences including:
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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 Etopen 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 Etopen?
- Etopen extended-release tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Etopen extended-release tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Serious stomach ulcers or bleeding can occur with the use of Etopen extended-release tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Etopen extended-release tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Etopen extended-release tablets is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID in it too. If it does or if you are not sure, check with your doctor or pharmacist.
- Do not take aspirin while you are using Etopen extended-release tablets unless your doctor tells you to.
- Etopen extended-release tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Etopen extended-release tablets.
- Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
- Use Etopen extended-release tablets with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding and kidney problems.
- Etopen extended-release tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Etopen extended-release tablets may cause harm to the fetus. Do not take it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Etopen extended-release tablets while you are pregnant. It is not known if Etopen extended-release tablets is found in breast milk. Do not breast-feed while taking Etopen extended-release tablets.
Etopen contraindications
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 Etopen. 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 Etopen. 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 Etopen (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 Etopen. Alcohol can increase the risk of stomach bleeding caused by Etopen.
Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Etopen can make your skin more sensitive to sunlight and sunburn may result.
References
- DailyMed. "MEROPENEM: 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).
- 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).
- 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).
Reviews
The results of a survey conducted on ndrugs.com for Etopen are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Etopen. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology