Belcetra Adverse Reactions

Hypersensitivity: In the occurrence of hypersensitivity such as shock, therapy should be discontinued.
Body as a whole: Anergia, fatigue, flushing, occasional chest pain, spasticity, syncope, withdrawal symptom.
Circulatory: Occasional hypertension, exacerbation of hypertension, hypotension, arrhythmia, palpitation, and tachycardia.
CNS and peripheral nervous system: Dizziness, headaches, tremor, occasional hyperkinesis, convulsion, hypertension, migraine, exacerbation of migraine, contraction of involuntary muscle, sensory anomaly, stupor, and vertigo may occur.
GI system: Bellyache, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting and occasional dysphagia, melena and tongue edema may occur.
Psychiatric disorder: Anorexia, anxiety, confusion, insomnia, nervousness, drowsiness, amnesia, depersonalization, depression, drug abuse and dependence, mood change, hallucinations, impotence, nightmares and abnormal thoughts may occur.
Blood: Occasional anemia may occur.
Respiratory: Occasional respiratory distress syndrome may occur.
Urinary: Proteinuria, dysuria, oliguria and urine retention may occur.
Skin: Pruritus, rash, sweating and urticaria may occur.
Others: Hepatic dysfunction, weight loss, tinnitus, abnormal vision and chilling may occur. Although not observed during clinical trials of tramadol/paracetamol, the occurrence of the following undesirable effects has been reported in the clinical trial and post marketing study related to the administration of tramadol or paracetamol.
Tramadol Hydrochloride: Vasodilation, orthostatic hypotension, bradycardia, collapse, myocardial ischemia, pulmonary edema, respiratory symptoms (Dyspnea, bronchospasm, wheeze, angioneurotic edema), allergic reactions (including anaphylaxis and urticaria, Steven-Johnsons syndrome/TENS), change in appetite, motor weakness, respiratory depression, cognitive function disorder, difficulty concentrating, depression, suicidal tendency, hepatitis, liver failure, GI bleeding and various Psychotic side-effects including change in mood, change in activity, and changes in cognitive and sensorial capacity can be individualized. Reported laboratory abnormalities included elevated creatinine and liver function tests. Post-marketing surveillance of tramadol has revealed rare alterations of warfarin effect, including elevation of prothrombin times. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures, coma, tachycardia, confusion, kinesioneurosis, muscle cramp, diarrhea) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs.
Worsening of asthma has been reported though a casual relationship has not been established. Symptoms of withdrawal reactions, similar to those occurring during opiate withdrawal may occur.
Paracetamol: Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to paracetamol are rare generally controlled by discontinuation of the drug and, when necessary, symptoms treatment. There have been reports of blood dyscrasias including thrombocytopenia and agranulocytosis, but there were not necessarily casually related to paracetamol. There have been several reports that suggest that paracetamol may produce hypoprothrombinemia when administered with warfarin-like compounds. In other studies, prothrombin time did not change.
Inform the doctor of pharmacist if any side effects occur.