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In placebo-controlled studies, 9% of peoples treated with sibutramine and 7% of peoples treated with placebo withdrew for adverse events. In placebo-controlled studies, the most frequent manifestations were anorexia, dry mouth, insomnia, headaches, and constipation. Adverse effects in these researches occurring in less than 1% of sibutramine treated individuals and more commonly than in the placebo group are given below.
Body as a whole: back pain, headache, flu syndrome, asthenia, injury accident, abdominal pain, neck pain, chest pain, and allergic reaction.
Digestive system: Constipation, anorexia, increased appetite, dyspepsia, nausea, vomiting, gastritis, rectal disorder.
Metabolic & Nutritional: Generalized edema, thirst.
Musculoskeletal system: Myalgia, arthralgia, joint disorder, and Arthralgia.
Nervous system: dry mouth, dizziness, insomnia, nervousness, anxiety, depression, drowsiness, depression, CNS stimulation, Somnolence, emotional lability.
Respiratory system: Pharyngitis, rhinitis, sinusitis, laryngitis, and cough incr case.
Appendages and Skin: sweating, rash, acne, and herpes simplex.
Special senses: ear disorder, ear pain, and taste supervision.
System: urinary tract infection, Dysmenorrhea, vaginal monilia, and metrorrhagia.
Other Adverse Events
Convulsions have seemed as an adverse condition in three of 2068 peoples treated by sibutramine and in none of 884 people treated by placebo. Two of the 3 peoples with seizure problems had strongly predisposing factors. The incidence in all subjects who taken sibutramine was less than 0.1%.
Short-term interstitial nephritis was reported in one obese patient taking sibutramine during premarketing studies. After discontinuation of the medicine, dialysis and oral corticosteroids were taken; renal function normalized.
Altered Laboratory Findings
Abnormal liver function tests, such as increases in ALT, AST, LDH, GGT, alkaline phosphate, and bilirubin, were reported as adverse effects in 1.6% of sibutramine-treated obese patients and placebo-controlled trials compared with 0.8% of placebo-treated patients.
The voluntary effects of side effects temporally associated with the use of sibutramine are mentioned below. It is crucial to emphasize that although these conditions occurred during treatment with sibutramine, they may have no causal relationship with the medication. Weight reduction itself may be associated with an increased risk for some of these effects.
Allergic hypersensitivity reactions ranging from mild urticaria and skin eruption to angioedema and anaphylaxis have been reported.
Other postmarketing Events
Cardiovascular system: congestive heart failure, atrial fibrillation, angina pectoris, heart arrest, decreased heart rate, supraventricular tachycardia, myocardial infarction, syncope, vascular headache, ventricular tachycardia, ventricular fibrillation.
Body as a whole: anaphylactoid reaction, chest tightness, chest pressure, anaphylactic shock, limb pain, sudden or unexpected death.
Digestive system: cholelithiasis, cholecystitis, duodenal ulcers, gastrointestinal bleeding, intestinal obstruction, increased salivation, stomach ulcers, mouth ulcers, and tongue edema.
Special senses: blurred vision, abdominal vision, dry eye, increased intraocular pressure, otitis media, otitis external, tinnitus, photosensitivity.
Respiratory system: nasal congestion, epistaxis, respiratory disorder, skin and appendages alopecia, photosensitivity.
Abuse and Physical and Psychological Dependence Medical experts should carefully evaluate individuals for a history of drug abuse and follow them carefully, observing them for signs of damage or misuse.
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