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XANAX®, CIV (alprazolam) Adverse Reactions

ADVERSE REACTIONS

Side effects to XANAX Tablets, if they occur, are generally observed at the beginning of therapy and usually disappear upon continued medication. In the usual patient, the most frequent side effects are likely to be an extension of the pharmacological activity of alprazolam, eg, drowsiness or light-headedness.

The data cited in the two tables below are estimates of untoward clinical event incidence among patients who participated under the following clinical conditions: relatively short duration (ie, four weeks) placebo-controlled clinical studies with dosages up to 4 mg/day of XANAX (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg/day of XANAX in patients with panic disorder, with or without agoraphobia.

These data cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics, and other factors often differ from those in clinical trials. These figures cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials are conducted under a different set of conditions.

Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the untoward event incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce it [an untoward event] in others.)

Additionally, for anxiety disorders the cited figures can provide the prescriber with an indication as to the frequency with which physician intervention (eg, increased surveillance, decreased dosage or discontinuation of drug therapy) may be necessary because of the untoward clinical event.

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Anxiety Disorders

ANXIETY DISORDERS
Treatment-Emergent Symptom Incidence* Incidence of Intervention Because of Symptom
XANAX PLACEBO XANAX
*
Events reported by 1% or more of XANAX patients are included.
None reported
Number of Patients 565 505 565
% of Patients Reporting:
Central Nervous System
  Drowsiness 41.0 21.6 15.1
  Light-headedness 20.8 19.3 1.2
  Depression 13.9 18.1 2.4
  Headache 12.9 19.6 1.1
  Confusion 9.9 10.0 0.9
  Insomnia 8.9 18.4 1.3
  Nervousness 4.1 10.3 1.1
  Syncope 3.1 4.0
  Dizziness 1.8 0.8 2.5
  Akathisia 1.6 1.2
  Tiredness/Sleepiness 1.8
Gastrointestinal
  Dry Mouth 14.7 13.3 0.7
  Constipation 10.4 11.4 0.9
  Diarrhea 10.1 10.3 1.2
  Nausea/Vomiting 9.6 12.8 1.7
  Increased Salivation 4.2 2.4
Cardiovascular
  Tachycardia/Palpitations 7.7 15.6 0.4
  Hypotension 4.7 2.2
Sensory
  Blurred Vision 6.2 6.2 0.4
Musculoskeletal
  Rigidity 4.2 5.3
  Tremor 4.0 8.8 0.4
Cutaneous
  Dermatitis/Allergy 3.8 3.1 0.6
Other
  Nasal Congestion 7.3 9.3
  Weight Gain 2.7 2.7
  Weight Loss 2.3 3.0

In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

Treatment-Emergent Adverse Events Reported in Placebo-Controlled Trials of Panic Disorder

PANIC DISORDER
Treatment-Emergent Symptom Incidence*
XANAX PLACEBO
*
Events reported by 1% or more of XANAX patients are included.
Number of Patients 1388 1231
% of Patients Reporting:
Central Nervous System
  Drowsiness 76.8 42.7
  Fatigue and Tiredness 48.6 42.3
  Impaired Coordination 40.1 17.9
  Irritability 33.1 30.1
  Memory Impairment 33.1 22.1
  Light-headedness/Dizziness 29.8 36.9
  Insomnia 29.4 41.8
  Headache 29.2 35.6
  Cognitive Disorder 28.8 20.5
  Dysarthria 23.3 6.3
  Anxiety 16.6 24.9
  Abnormal Involuntary Movement 14.8 21.0
  Decreased Libido 14.4 8.0
  Depression 13.8 14.0
  Confusional State 10.4 8.2
  Muscular Twitching 7.9 11.8
  Increased Libido 7.7 4.1
  Change in Libido (Not Specified) 7.1 5.6
  Weakness 7.1 8.4
  Muscle Tone Disorders 6.3 7.5
  Syncope 3.8 4.8
  Akathisia 3.0 4.3
  Agitation 2.9 2.6
  Disinhibition 2.7 1.5
  Paresthesia 2.4 3.2
  Talkativeness 2.2 1.0
  Vasomotor Disturbances 2.0 2.6
  Derealization 1.9 1.2
  Dream Abnormalities 1.8 1.5
  Fear 1.4 1.0
  Feeling Warm 1.3 0.5
Gastrointestinal
  Decreased Salivation 32.8 34.2
  Constipation 26.2 15.4
  Nausea/Vomiting 22.0 31.8
  Diarrhea 20.6 22.8
  Abdominal Distress 18.3 21.5
  Increased Salivation 5.6 4.4
Cardio-Respiratory
  Nasal Congestion 17.4 16.5
  Tachycardia 15.4 26.8
  Chest Pain 10.6 18.1
  Hyperventilation 9.7 14.5
  Upper Respiratory Infection 4.3 3.7
Sensory
  Blurred Vision 21.0 21.4
  Tinnitus 6.6 10.4
Musculoskeletal
  Muscular Cramps 2.4 2.4
  Muscle Stiffness 2.2 3.3
Cutaneous
  Sweating 15.1 23.5
  Rash 10.8 8.1
Other
  Increased Appetite 32.7 22.8
  Decreased Appetite 27.8 24.1
  Weight Gain 27.2 17.9
  Weight Loss 22.6 16.5
  Micturition Difficulties 12.2 8.6
  Menstrual Disorders 10.4 8.7
  Sexual Dysfunction 7.4 3.7
  Edema 4.9 5.6
  Incontinence 1.5 0.6
  Infection 1.3 1.7

In addition to the relatively common (ie, greater than 1%) untoward events enumerated in the table above, the following adverse events have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients (see PRECAUTIONS, General).

Adverse Events Reported as Reasons for Discontinuation in Treatment of Panic Disorder in Placebo-Controlled Trials

In a larger database comprised of both controlled and uncontrolled studies in which 641 patients received XANAX, discontinuation-emergent symptoms which occurred at a rate of over 5% in patients treated with XANAX and at a greater rate than the placebo treated group were as follows:

DISCONTINUATION-EMERGENT SYMPTOM INCIDENCE
Percentage of 641 XANAX-Treated Panic Disorder Patients Reporting Events
Body System/Event
Neurologic   Gastrointestinal
Insomnia 29.5   Nausea/Vomiting 16.5
Light-headedness 19.3   Diarrhea 13.6
Abnormal involuntary movement 17.3   Decreased salivation 10.6
Headache 17.0   Metabolic-Nutritional
Muscular twitching 6.9   Weight loss 13.3
Impaired coordination 6.6   Decreased appetite 12.8
Muscle tone disorders 5.9
Weakness 5.8   Dermatological
Psychiatric   Sweating 14.4
Anxiety 19.2
Fatigue and Tiredness 18.4   Cardiovascular
Irritability 10.5   Tachycardia 12.2
Cognitive disorder 10.3
Memory impairment 5.5   Special Senses
Depression 5.1   Blurred vision 10.0
Confusional state 5.0

From the studies cited, it has not been determined whether these symptoms are clearly related to the dose and duration of therapy with XANAX in patients with panic disorder. There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX Tablets (see WARNINGS).

To discontinue treatment in patients taking XANAX, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of XANAX be decreased by no more than 0.5 mg every three days (see DOSAGE AND ADMINISTRATION). Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

As with all benzodiazepines, paradoxical reactions such as stimulation, increased muscle spasticity, sleep disturbances, hallucinations and other adverse behavioral effects such as agitation, rage, irritability, and aggressive or hostile behavior have been reported rarely. In many of the spontaneous case reports of adverse behavioral effects, patients were receiving other CNS drugs concomitantly and/or were described as having underlying psychiatric conditions. Should any of the above events occur, alprazolam should be discontinued. Isolated published reports involving small numbers of patients have suggested that patients who have borderline personality disorder, a prior history of violent or aggressive behavior, or alcohol or substance abuse may be at risk for such events. Instances of irritability, hostility, and intrusive thoughts have been reported during discontinuation of alprazolam in patients with posttraumatic stress disorder.

Post Introduction Reports

Various adverse drug reactions have been reported in association with the use of XANAX since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of XANAX cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, photosensitivity reaction, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea (see PRECAUTIONS).

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