Lexotan Adverse Reactions

Post Marketing: Description of selected adverse drug reactions from postmarketing experience Bromazepam (Lexotan) is well tolerated in therapeutic doses. The following undesirable effects may occur: Psychiatric Disorders: Confusional state, disorientation, emotional and mood disturbances.
These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration. Changes in libido have been reported occasionally.
Depression: Pre-existing depression may be unmasked during benzodiazepine use.
Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, anger, nightmares, hallucinations, psychoses, inappropriate behavior, nervousness, anxiety, abnormal dreams, hyperactivity and other adverse behavioral effects are known to occur.
They are more likely to occur in children and elderly patients than in other patients.
Dependence: Chronic use (even at therapeutic doses) may lead to the development of physical and psychological drug dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see General and Drug Abuse and Dependence under Precautions).
Abuse of benzodiazepines is more common in poly-drug abusers.
Nervous System Disorder: Drowsiness, headache, dizziness, decreased alertness, ataxia.
These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
Anterograde amnesia may occur at therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behavior.
Eye Disorders: Diplopia, this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration.
Gastrointestinal Disorders: Gastrointestinal disorders have been reported occasionally.
Skin and Subcutaneous Tissue Disorders: Skin reactions have been reported occasionally.
Musculoskeletal and Connective Tissue Disorders: Muscle weakness, this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration.
General Disorders and Administration Site Conditions: Fatigue, this phenomenon occurs predominantly at the start of therapy and usually disappears with repeated administration.
Injury, Poisoning and Procedural Complications: There have been reports of falls and fractures in benzodiazepine users. The risk is increased in those taking concomitant sedatives (including alcoholic beverages) and in the elderly.
Respiratory Disorders: Respiratory depression.
Cardiac Disorders: Cardiac failure including cardiac arrest.