What are the possible side effects of Nomadol?
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Itching, redness, tearing, or other sign of eye irritation not present before use of Nomadol or becoming worse during use
- redness of the clear part of the eye
- sensitivity to light
- swelling of the eye
- tearing
- throbbing pain
- Blurred vision or other change in vision
- eye irritation or redness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Stinging or burning of the eye when medicine is applied
- Dry eyes
- headache
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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Side effects of Nomadol in details
Adverse reaction rates increase with higher doses of Nomadol Tromethamine. Practitioners should be alert for the severe complications of treatment with Nomadol Tromethamine, such as G.I. ulceration, bleeding and perforation, postoperative bleeding, acute renal failure, anaphylactic and anaphylactoid reactions and liver failure. These NSAID-related complications can be serious in certain patients for whom Nomadol Tromethamine is indicated, especially when the drug is used inappropriately.
In patients taking Nomadol Tromethamine or other NSAIDs in clinical trials, the most frequently reported adverse experiences in approximately 1% to 10% of patients are:
Additional adverse experiences reported occasionally (<1% in patients taking Nomadol Tromethamine or other NSAIDs in clinical trials) include:
Body as a Whole: fever, infections, sepsis
Cardiovascular: congestive heart failure, palpitation, pallor, tachycardia, syncope
Dermatologic: alopecia, photosensitivity, urticaria
Gastrointestinal: anorexia, dry mouth, eructation, esophagitis, excessive thirst, gastritis, glossitis, hematemesis, hepatitis, increased appetite, jaundice, melena, rectal bleeding
Hemic and Lymphatic: ecchymosis, eosinophilia, epistaxis, leukopenia, thrombocytopenia
Metabolic and Nutritional: weight change
Nervous System: abnormal dreams, abnormal thinking, anxiety, asthenia, confusion, depression, euphoria, extrapyramidal symptoms, hallucinations, hyperkinesis, inability to concentrate, insomnia, nervousness, paresthesia, somnolence, stupor, tremors, vertigo, malaise
Reproductive, female: infertility
Respiratory: asthma, cough, dyspnea, pulmonary edema, rhinitis
Special Senses: abnormal taste, abnormal vision, blurred vision, hearing loss
Urogenital: cystitis, dysuria, hematuria, increased urinary frequency, interstitial nephritis, oliguria/polyuria, proteinuria, renal failure, urinary retention
Other rarely observed reactions (reported from postmarketing experience in patients taking Nomadol Tromethamine or other NSAIDs) are:
Body as a Whole: angioedema, death, hypersensitivity reactions such as anaphylaxis, anaphylactoid reaction, laryngeal edema, tongue edema, myalgia
Cardiovascular: arrhythmia, bradycardia, chest pain, flushing, hypotension, myocardial infarction, vasculitis
Dermatologic: exfoliative dermatitis, erythema multiforme, Lyell's syndrome, bullous reactions including Stevens-
Johnson syndrome and toxic epidermal necrolysis
Gastrointestinal: acute pancreatitis, liver failure, ulcerative stomatitis, exacerbation of inflammatory bowel disease
(ulcerative colitis, Crohn's disease)
Hemic and Lymphatic: agranulocytosis, aplastic anemia, hemolytic anemia, lymphadenopathy, pancytopenia, post operative wound hemorrhage (rarely requiring blood transfusion - see,, and )
Metabolic and Nutritional: hyperglycemia, hyperkalemia, hyponatremia
Nervous System: aseptic meningitis, convulsions, coma, psychosis
Respiratory: bronchospasm, respiratory depression, pneumonia
Special Senses: conjunctivitis
Urogenital: flank pain with or without hematuria and/or azotemia, hemolytic uremic syndrome
Postmarketing Surveillance Study
A large postmarketing observational, nonrandomized study, involving approximately 10,000 patients receiving Nomadol Tromethamine, demonstrated that the risk of clinically serious gastrointestinal (GI) bleeding was dose-dependent. This was particularly true in elderly patients who received an average daily dose greater than 60 mg/day of Nomadol Tromethamine.
What is the most important information I should know about Nomadol?
- Nomadol tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Nomadol 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 Nomadol tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Nomadol 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.
- Nomadol tablets 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 Nomadol tablets unless your doctor tells you to.
- Check with your doctor or pharmacist before you take acetaminophen while you are taking Nomadol tablets. The risk of liver problems may be increased.
- Lab tests, including kidney function, liver function, blood electrolyte levels, complete blood cell counts, and blood pressure, may be performed while you use Nomadol tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
- Use Nomadol tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
- Nomadol tablets should not be used in CHILDREN younger than 17 years old; safety and effectiveness in these children have not been confirmed.
- PREGNANCY and BREAST-FEEDING: Nomadol tablets 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 Nomadol tablets while you are pregnant. Nomadol tablets is found in breast milk. Do not breast-feed while taking Nomadol tablets.
Nomadol contraindications
Nomadol Tromethamine is contraindicated in patients with previously demonstrated hypersensitivity to Nomadol Tromethamine.
Nomadol Tromethamine is contraindicated in patients with active peptic ulcer disease, in patients with recent gastrointestinal bleeding or perforation and in patients with a history of peptic ulcer disease or gastrointestinal bleeding.
Nomadol Tromethamine 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-like reactions to NSAIDs have been reported in such patients.
Nomadol Tromethamine is contraindicated as prophylactic analgesic before any major surgery.
Nomadol Tromethamine is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery.
Nomadol Tromethamine is contraindicated in patients with advanced renal impairment or in patients at risk for renal failure due to volume depletion.
Nomadol Tromethamine is contraindicated in labor and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.
Nomadol Tromethamine inhibits platelet function and is, therefore, contraindicated in patients with suspected or confirmed cerebrovascular bleeding, hemorrhagic diathesis, incomplete hemostasis and those at high risk of bleeding.
Nomadol Tromethamine is contraindicated in patients currently receiving aspirin or NSAIDs because of the cumulative risks of inducing serious NSAID-related adverse events.
The concomitant use of Nomadol Tromethamine and probenecid is contraindicated.
The concomitant use of Nomadol Tromethamine and pentoxifylline is contraindicated.
Nomadol Tromethamine injection is contraindicated for neuraxial (epidural or intrathecal) administration due to its alcohol content.
References
- European Chemicals Agency - ECHA. "5-benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic 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).
- NIST. "1H-Pyrrolizine-1-carboxylic acid, 2,3-dihydro-5-benzoyl-, (.+/-.)-". http://www.nist.gov/srd/nist1a.cfm (accessed September 17, 2018).
- KEGG. "Target-based classification of drugs". http://www.genome.jp/kegg-bin/get_ht... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Nomadol 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 Nomadol. 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
