Alprazolam (Xanax) Adverse Reactions
- agitation
- akathisia
- amnesia
- anorexia
- appetite stimulation
- ataxia
- confusion
- constipation
- depression
- dizziness
- drowsiness
- dysuria
- elevated hepatic enzymes
- emotional lability
- fatigue
- flushing
- galactorrhea
- gynecomastia
- hepatic failure
- hepatitis
- hyperprolactinemia
- hypersalivation
- hyperventilation
- hypoesthesia
- hypotension
- impaired cognition
- irritability
- libido decrease
- libido increase
- menstrual irregularity
- physiological dependence
- psychological dependence
- Stevens-Johnson syndrome
- teratogenesis
- tolerance
- tremor
- weight gain
- weight loss
- withdrawal
- xerostomia
Alprazolam (Xanax) Adverse Reactions
The most frequent adverse effects of alprazolam are likely to be extensions of the drug’s CNS-depressant effects, e.g., drowsiness or lightheadedness. The incidence and severity of these effects will vary with the dose used and condition being treated. Tolerance to these adverse effects may develop over time. Additionally, tolerance may develop to the sedative or anti-anxiety effects of benzodiazepines. In general, the adverse effects that occur with alprazolam extended-release formulation are similar to those that occur with the immediate-release dosage form.
In some cases paradoxical stimulation can occur secondary to alprazolam. This is of particular significance in psychiatric patients who may be receiving other CNS-depressants, and have underlying behavioral problems. Alprazolam should be withdrawn if there is any evidence of agitation, rage, irritability, aggressive or hostile behavior.
According to the manufacturer’s literature, more than 1% of patients treated with alprazolam for anxiety or panic disorder experienced the following adverse events at incidence rates 5% or greater than placebo: drowsiness; fatigue; ataxia; memory impairment or amnesia; impaired cognition; dysarthria (slurred speech); libido increase or libido decrease (sexual dysfunction); akathisia; emotional lability such as agitation, irritability, disinhibition, talkativeness, derealization, dream abnormalities, or fear; feeling warm; constipation; upper respiratory infection; rash; appetite stimulation or appetite loss (anorexia); weight gain or weight loss; dysuria; menstrual irregularity; incontinence; xerostomia; hypersalivation and hypotension. In controlled clinical trials evaluating alprazolam extended-release for panic disorder, sedation and somnolence were the most common reason for discontinuation of treatment (discontinuation rate of 11% in the active group vs. 1% in placebo). Roughly 68% of patients treated with alprazolam extended-release experienced treatment-emergent drowsiness (i.e., somnolence and sedation) vs. 29% on placebo.
Adverse events occurring in more than 1% of patients on alprazolam therapy, with incidence rates between 1 and 5% and greater than placebo: confusion, blurred vision, muscle cramps, lightheadedness and dizziness.
Adverse events occurring in more than 1% of patients on alprazolam therapy, with incidence rates less than 1% but greater than placebo: muscular twitching or muscle tone disorder, anxiety, headache, insomnia, weakness, syncope, paresthesias, vasomotor disturbance, decreased salivation, nausea/vomiting, diarrhea, abdominal distress, nasal congestion, tachycardia, chest pain, hyperventilation, tinnitus, muscle stiffness, sweating, edema, and infection.
Less common adverse events, occurring in less than 1% of patients on alprazolam therapy include: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.
Even after short-term use of alprazolam, there is evidence of physiological dependence, psychological dependence and subsequent adverse withdrawal symptoms. These symptoms may range from mild dysphoria and insomnia to a major withdrawal syndrome including abdominal and muscle cramps, vomiting, sweating, tremors and seizures. Higher doses and prolonged use are more likely to cause dependence. Withdrawal may lead to rebound of symptoms of panic disorder more severe than before treatment. The following symptoms have been identified as those associated with alprazolam withdrawal: heightened sensory perception, impaired concentration, dysosmia, clouded sensorium, paresthesias, muscle cramps, muscle twitch, diarrhea, blurred vision, appetite decrease and weight loss. Anxiety and insomnia were also common, but may be associated with the underlying disease state and not a consequence of alprazolam withdrawal. If discontinuation of therapy is indicated, the dose of alprazolam should be reduced slowly and cautiously. According to data involving 641 patients receiving alprazolam for the treatment of panic disorder, adverse events emerging upon discontinuation of therapy occurred in the following percentage of patients: insomnia 29.5%, lightheadedness 19.3%, abnormal involuntary movement 17.3%, headache 17%, muscular twitching 6.9%, impaired coordination 6.6%, muscle-tone disorders 5.9%, weakness 5.8%, anxiety 19.2%, fatigue or tiredness 18.4%, irritability 10.5%, cognitive disorder 10.3%, memory impairment 5.5%, depression 5.1%, confusion 5%, nausea/vomiting 16.5%, diarrhea 13.6%, decreased salivation 10.6%, weight loss 13.3%, decreased appetite 12.8%, sweating 14.4%, tachycardia, 12.2% and blurred vision 10%. Discontinuation-emergent symptoms were similar for patients receiving extended-release alprazolam for panic disorder, with the addition of tremor (28% vs. 10% placebo), hypoesthesia and paraesthesia (both roughly 7% vs. 3% placebo), nervousness (22% vs. 9 % placebo), hyperventilation (8.5% vs. 2.7% placebo), appetite loss (9.5% vs. 3.8% placebo) and flushing (5.9% vs. 2.7% placebo).
Some hematological changes have been observed in patients receiving alprazolam. Few changes were considered to be of physiological significance. Patients receiving alprazolam over prolonged periods should have periodic blood counts.
Spontaneous (post-marketing) ADR reports associated with alprazolam include: elevated hepatic enzymes, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia and galactorrhea. A causal relationship with alprazolam has not been established.
Alprazolam is classified as FDA pregnancy risk category D. Many benzodiazepines have been associated with teratogenesis. Use of benzodiazepines during pregnancy, particularly in the first trimester, generally increases the risk of congenital malformations and decreases viability.
[ Last revised: 3/26/2003 1:19:00 PM ]
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