|Adverse events, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication or decreased dosage.The following undesirable effects have been observed and reported during treatment with alprazolam with the following frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).|
|MedDRA System Organ Class||Frequency||Undesirable Effects|
|Metabolism and nutrition disorders||Common||Decreased appetite|
|Psychiatric disorders||Common||Confusional state, depression, disorientation, libido decreased
|Uncommon||Anxiety, insomnia, nervousness, hypomania, mania (see section 4.4 Special warnings and precautions for use
), hallucination, anger, aggression, hostility, agitation, libido disorder, thinking abnormal, psychomotor hyperactivity
|Nervous system disorders||Very common||Sedation, somnolence
|Common||Ataxia, balance disorder, coordination abnormal, memory impairment, dysarthria, disturbance in attention, hypersomnia, lethargy, dizziness, headache
|Uncommon||Amnesia, tremor, dystonia
|Not Known||Autonomic nervous system imbalance
|Eye disorders||Common||Vision blurred|
|Gastrointestinal disorders||Common||Constipation, dry mouth, nausea
|Hepatobiliary disorders||Uncommon||Hepatitis, hepatic function abnormal, jaundice
|Skin and subcutaneous tissue disorders||Uncommon||Dermatitis|
|Musculoskeletal and connective tissue disorders||Uncommon||Muscular weakness|
|Renal and urinary disorders ||Uncommon ||Incontinence, urinary retention
|Reproductive system and breast disorders||Uncommon||Sexual dysfunction, menstruation irregular
|General disorders and administration site conditions||Common||Fatigue, irritability|
|Not Known||Peripheral oedema|
|Investigations||Uncommon||Change in weight, intraocular pressure increased
Withdrawal symptomsWithdrawal symptoms have occurred following rapid decrease or abrupt discontinuance of benzodiazepines including alprazolam. These can range from mild dysphoria and insomnia to a major syndrome, which may include abdominal and muscle cramps, vomiting, sweating, tremor and convulsions. In addition, withdrawal seizures have occurred upon rapid decrease or abrupt discontinuation of therapy with alprazolam.
Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. (See Section 4.4 Special warnings and precautions for use).
Depression Pre-existing depression may be unmasked during benzodiazepine use.
Psychiatric and 'paradoxical' reactions Reactions like restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepine or benzodiazepine-like agents. They may be quite severe with this product. They are more likely to occur in children and the elderly.
Dependence Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see Section 4.4 Special warnings and precautions for use). Psychic dependence may occur. Abuse of benzodiazepines has been reported.