Orofen Retard Side effects

• Side effects of Orofen Retard in details
• Orofen Retard contraindications
• Orofen Retard reviews

What are the possible side effects of Orofen Retard?

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 Orofen Retard 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;
• confusion, tremors or shaking;
• 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.

Less serious side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation; bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• dry mouth;
• increased sweating, runny nose;
• blurred vision; or
• ringing in your ears.

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 Orofen Retard in details

The incidence of common adverse reactions (above 1%) was obtained from a population of 835 Orofen Retard (Orofen Retard) -treated patients in double-blind trials lasting from 4 to 54 weeks and in 622 Oruvail-treated (200 mg/day) patients in trials lasting from 4 to 16 weeks.

Minor gastrointestinal side effects predominated; upper gastrointestinal symptoms were more common than lower gastrointestinal symptoms. In crossover trials in 321 patients with rheumatoid arthritis or osteoarthritis, there was no difference in either upper or lower gastrointestinal symptoms between patients treated with 200 mg of Oruvail (Orofen Retard) once a day or 75 mg of Orofen Retard (Orofen Retard) TID (225 mg/day). Peptic ulcer or GI bleeding occurred in controlled clinical trials in less than 1% of 1,076 patients; however, in open label continuation studies in 1,292 patients the rate was greater than 2%.

The incidence of peptic ulceration in patients on NSAIDs is dependent on many risk factors including age, sex, smoking, alcohol use, diet, stress, concomitant drugs such as aspirin and corticosteroids, as well as the dose and duration of treatment with NSAIDs.

Gastrointestinal reactions were followed in frequency by central nervous system side effects, such as headache, dizziness, or drowsiness. The incidence of some adverse reactions appears to be dose-related. Rare adverse reactions (incidence less than 1%) were collected from one or more of the following sources: foreign reports to manufacturers and regulatory agencies, publications, U.S. clinical trials, and/or U.S. postmarketing spontaneous reports.

Reactions are listed below under body system, then by incidence or number of cases in decreasing incidence.

Incidence Greater than 1% (Probable Causal Relationship)

Digestive: Dyspepsia (11%), nausea*, abdominal pain*, diarrhea*, constipation*, flatulence*, anorexia, vomiting, stomatitis.

Nervous System: Headache*, dizziness, CNS inhibition (i.e., pooled reports of somnolence, malaise, depression, etc.) or excitation (i.e., insomnia, nervousness, dreams, etc.)*.

Special Senses: Tinnitus, visual disturbance.

Skin and Appendages: Rash.

Urogenital: Impairment of renal function (edema, increased BUN)*, signs or symptoms of urinary-tract irritation.

* Adverse events occurring in 3 to 9% of patients.

Incidence Less than 1% (Probable Causal Relationship)

Body as a Whole: Chills, facial edema, infection, pain, allergic reaction, anaphylaxis.

Cardiovascular: Hypertension, palpitation, tachycardia, congestive heart failure, peripheral vascular disease, vasodilation.

Digestive: Appetite increased, dry mouth, eructation, gastritis, rectal hemorrhage, melena, fecal occult blood, salivation, peptic ulcer, gastrointestinal perforation, hematemesis, intestinal ulceration, hepatic dysfunction, hepatitis, cholestatic hepatitis, jaundice.

Hemic: Hypocoagulability, agranulocytosis, anemia, hemolysis, purpura, thrombocytopenia.

Metabolic and Nutritional: Thirst, weight gain, weight loss, hyponatremia.

Musculoskeletal: Myalgia.

Nervous System: Amnesia, confusion, impotence, migraine, paresthesia, vertigo.

Respiratory: Dyspnea, hemoptysis, epistaxis, pharyngitis, rhinitis, bronchospasm, laryngeal edema.

Skin and Appendages: Alopecia, eczema, pruritus, purpuric rash, sweating, urticaria, bullous rash, exfoliative dermatitis, photosensitivity, skin discoloration, onycholysis, toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome.

Special Senses: Conjunctivitis, conjunctivitis sicca, eye pain, hearing impairment, retinal hemorrhage and pigmentation change, taste perversion.

Urogenital: Menometrorrhagia, hematuria, renal failure, interstitial nephritis, nephrotic syndrome.

Incidence Less than 1% (Causal Relationship Unknown)

The following rare adverse reactions, whose causal relationship to Orofen Retard is uncertain, are being listed to serve as alerting information to the physician.

Body as a Whole: Septicemia, shock.

Cardiovascular: Arrhythmias, myocardial infarction.

Digestive: Buccal necrosis, ulcerative colitis, microvesicular steatosis, pancreatitis.

Endocrine: Diabetes mellitus (aggravated).

Nervous System: Dysphoria, hallucination, libido disturbance, nightmares, personality disorder, aseptic meningitis.

Urogenital: Acute tubulopathy, gynecomastia.

What is the most important information I should know about Orofen Retard?

• Orofen Retard extended-release capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Orofen Retard extended-release capsules 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 Orofen Retard extended-release capsules. Taking it in high doses, for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Orofen Retard extended-release capsules with food will NOT reduce the risk of these effects. If you have severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling, contact your doctor or emergency room right away.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Orofen Retard extended-release capsules is an NSAID. Before you start any new medicine, check the label to see if it has an NSAID (eg, ibuprofen) 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 Orofen Retard extended-release capsules unless your doctor tells you to.
• Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Orofen Retard extended-release capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Orofen Retard extended-release capsules with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
• Orofen Retard extended-release capsules should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Orofen Retard extended-release capsules may cause harm to the fetus. Do not use 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 using Orofen Retard extended-release capsules while you are pregnant. It is not known if Orofen Retard extended-release capsules is found in breast milk. Do not breast-feed while taking Orofen Retard extended-release capsules.

Orofen Retard contraindications

Orofen Retard (Orofen Retard) and Oruvail are contraindicated in patients who have shown hypersensitivity to Orofen Retard.

Orofen Retard (Orofen Retard) and Oruvail should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic reactions to Orofen Retard have been reported in such patients.

Orofen Retard (Orofen Retard) and Oruvail are contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

References

1. DailyMed. "KETOPROFEN: 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. "ketoprofen: 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. "Ketoprofen: 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).

Reviews

The results of a survey conducted on ndrugs.com for Orofen Retard 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 Orofen Retard. 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.

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Information checked by Dr. Sachin Kumar, MD Pharmacology