The most frequently reported incidents are those originating from the central nervous system and the digestive system. The most common reported symptoms are nausea, dizziness, and drowsiness.
In addition, the following effects have been frequently observed, although in general the frequency is lower: Body as a whole: asthenia, fatigue, hot flushes.
Central and peripheral nervous system: headache, tremor.
Gastrointestinal system: abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, vomiting.
Psychiatric disorders: anorexia, anxiety, confusion, euphoria, insomnia, nervousness.
Skin and appendages: pruritus, rash, increased sweating.
Clinically significant but infrequently reported adverse experiences and at least possible cause-and-effect relationships with Ulcetra include: Body as a whole: chest pain, rigors, syncope, withdrawal syndrome.
Cardiovascular disorders: hypertension, aggravated hypertension, hypotension.
Central and peripheral nervous system: ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor coma, vertigo.
Gastrointestinal system: dysphagia, melena, tongue edema.
Hearing and vestibular disorders: tinnitus.
Heart rate and rhythm disorders: arrhythmia, palpitation, tachycardia.
Liver and biliary system: abnormal hepatic function.
Metabolic and nutritional disorders: weight decrease.
Psychiatric disorders: amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking.
Red blood cell disorders: anemia.
Respiratory system: dyspnea.
Urinary system: albuminuria, micturition disorder, oliguria, urinary retention.
Vision disorder: abnormal vision.
Other clinically significant adverse events or events previously reported in clinical trials or post marketing reports with Tramadol hydrochloride: Other events which have been reported with the use of Tramadol products include: Orthostatic hypotension, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, suicidal tendency, and hepatitis.
Reported laboratory abnormalities included elevated creatinine. Serotonin syndrome (whose symptoms may include fever, excitation, chills, and agitation) has been reported with Tramadol when used concomitantly with other serotoninergic agents such as SSRIs and MAO inhibitors.
Post-marketing experiences with the use of products containing Tramadol include the rarely reported delirium, miosis, midriasis, and speech disorders, and very rare movement disorders. Post-marketing surveillance of Tramadol has shown a rare change in the effects of warfarin, including elevated prothrombin time. Hypoglycemic cases have been reported but are very rare in patients taking Tramadol. Most reports occurred in patients with predisposing risk factors, including diabetes or renal insufficiency, or in elderly patients. Hyponatremia and/or SIADH cases have been reported very rarely in patients taking Tramadol, usually in patients with predisposing risk factors, such as the elderly or used concomitantly with drugs that may cause hyponatremia.
Other clinically significant adverse experiences previously reported in clinical trials or post-marketing reports with Paracetamol: Allergic reactions (primarily skin rash) or reports of secondary hypersensitivity to Paracetamol are rare and generally managed by discontinuation of the drug, and when necessary, symptomatic treatment.
There have been several reports showing that Paracetamol can lead to hypoprothrombinemia when administered along with compounds such as warfarin. In other studies, prothrombin time did not change.
Other Services
Country
Account