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ATIVAN (lorazepam) Adverse Reactions

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Adverse Reactions

The adverse reaction most frequently reported was drowsiness.

Reported adverse reactions (by system) are:

Body as a Whole
angioedema, asthenia, muscle weakness, anaphylactic reactions, change in weight, hypersensitivity reactions, hyponatremia, hypothermia, SIADH;

Cardiovascular
hypotension, lowering in blood pressure;

Digestive
nausea, constipation, change in appetite, increase in bilirubin, jaundice, increase in liver transaminases, increase in alkaline phosphatase;

Hematological/Lymphatic
agranulocytosis, pancytopenia, thrombocytopenia;

Nervous System and Special Senses (benzodiazepine effects on the CNS are dose dependent, with more severe CNS depression with higher doses)
anterograde amnesia, drowsiness, fatigue, sedation, ataxia, confusion, depression, unmasking of depression, dizziness, change in libido, impotence, decreased orgasm, extrapyramidal symptoms, tremor, vertigo, visual disturbances (including diplopia, and blurred vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, disinhibition, euphoria, coma, suicidal ideation/attempt, impaired attention/concentration, balance disorder, paradoxical reactions (including anxiety, agitation, excitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, hallucinations), psychomotor agitation;

Respiratory
respiratory depression, apnea, worsening of sleep apnea (the extent of respiratory depression with benzodiazepines is dose dependent - more severe depression at higher doses), worsening of obstructive pulmonary disease, and ear, nose and throat disturbances;

Skin
allergic skin reactions, alopecia.

There is evidence that tolerance develops to the sedative effects of benzodiazepines.

Release of hostility and other paradoxical effects such as irritability and excitability, are known to occur with the use of benzodiazepines. Paradoxical reactions may be more likely to occur in children or the elderly. Should paradoxical reactions occur, use of the drug should be discontinued. In addition, hypotension, mental confusion, slurred speech, over sedation and abnormal liver and kidney function tests and hematocrit values have been reported with these drugs.

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