Lotram Plus Adverse Reactions

The most frequently reported events were in the central nervous system and gastrointestinal system.
The most common report events were nausea, dizziness and somnolence.
In addition, the following effects have been frequently observed, through the frequency is generally 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.
Uncommon reported clinically significant adverse experiences with at least a possible causal link to tramadol + paracetamol 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, involuntarily muscle contractions, paresthesia, stupor, vertigo.
Gastrointestinal System: Dysphagia, melena, tongue edema.
Hearing and Vestibular Disorders: Tinnitus.
Heart Rate and Rhythm Disorders: Arrythmia, palpitation, tachycardia.
Liver and Biliary System: Liver test abnormalities.
Metabolic and Nutritional Disorders: Decreased weight.
Psychiatric Disorder: Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, bad dreams, abnormal thinking.
Red Blood Cell Disorders: Anemia.
Respiratory System: Dyspnea.
Urinary System: Albuminuria, micturition disorder, oliguria, urinary retention.
Vision Disorders: Abnormal vision.
Other Clinically Significant Adverse Experiences Previously Reported in Clinical Trials or Post-Marketing Reports With Tramadol HCl: Other events which have been reported with the use of tramadol products include: Orthostatic hypotension, hypotension, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, suicidal tendency and hepatitis.
Reported laboratory abnormalities include elevated creatinine. Serotonin syndrome (whose symptoms may include fever, excitation, shivering and agitation) has been reported with tramadol when used concomitantly with other serotonergic agents, SSRIs and MAO inhibitors. Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times.
Other Clinically Significant Adverse Experiences Previously Reported in Clinical Trials or Post-Marketing Reports with Paracetamol: Allergic reactions (primarily skin rash) or report of hypersensitivity secondary to paracetamol are rare and generally controlled by discontinuation.