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XANAX®, CIV Adverse Reactions (alprazolam)

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The data in the two tables below are estimates of adverse reaction incidence among adult patients who participated in:

  • 4-week placebo-controlled clinical studies with XANAX dosages up to 4 mg per day for the acute treatment of generalized anxiety disorder (Table 1)
  • Short-term (up to 10 weeks) placebo-controlled clinical studies with XANAX dosages up to 10 mg per day for panic disorder, with or without agoraphobia (Table 2).
Table 1: Adverse Reactions Occurring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials for Generalized Anxiety
XANAX
n=565
Placebo
n=505
Nervous system disorders
  Drowsiness41%22%
  Light-headedness21%19%
  Dizziness2%1%
  Akathisia2%1%
Gastrointestinal disorders
  Dry mouth15%13%
  Increased salivation4%2%
Cardiovascular disorders
  Hypotension5%2%
Skin and subcutaneous tissue disorders
  Dermatitis/allergy4%3%

In addition to the adverse reactions (i.e., greater than 1%) enumerated in the table above for patients with generalized anxiety disorder, the following adverse reactions 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.

Table 2: Adverse Reactions Occuring in ≥1% in XANAX-treated Patients and Greater than Placebo-treated Patients in Placebo-Controlled Trials (Up to 10 Weeks) for Panic Disorder
XANAX
n=1388
Placebo
n=1231
  Drowsiness77%43%
  Fatique and Tiredness49%42%
  Impaired Coordination40%18%
  Irritability33%30%
  Memory Impairment33%22%
  Cognitive Disorder29%21%
  Decreased Libido14%8%
  Dysartharia23%6%
  Confusional state10%8%
  Increased libido8%4%
  Change in libido (not specified)7%6%
  Disinhibition3%2%
  Talkativeness2%1%
  Derealization2%1%
Gastrointestinal disorders
  Constipation26%15%
  Increased salivation6%4%
Skin and subcutaneous tissue disorders
  Rash11%8%
Other
  Increased appetite33%23%
  Decreased appetite28%24%
  Weight gain27%18%
  Weight loss23%17%
  Micturition difficulties12%9%
  Menstrual disorders11%9%
  Sexual dysfunction7%4%
  Incontinence2%1%

In addition to the reactions (i.e., greater than 1%) enumerated in the table above for patients with panic disorder, the following adverse reactions have been reported in association with the use of XANAX: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Adverse Reactions 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 are shown in Table 3.

Table 3: Discontinuation-Emergent Symptom Incidence Reported in ≥5% of XANAX-treated Patients and > Placebo-treated Patients
XANAX-treated Patients
n=641
n=number of patients.
Nervous system disorders
Insomnia29.5%
Light-headedness19.3%
Abnormal involuntary movement17.3%
Headache17.0%
Muscular twitching6.9%
Impaired coordination6.6%
Muscle tone disorders5.9%
Weakness5.8%
Psychiatric disorders
Anxiety19.2%
Fatigue and Tiredness18.4%
Irritability10.5%
Cognitive disorder10.3%
Memory impairment5.5%
Depression5.1%
Confusional state5.0%
Gastrointestinal disorders
Nausea/Vomiting16.5%
Diarrhea13.6%
Decreased salivation10.6%
Metabolism and nutrition disorders
Weight loss13.3%
Decreased appetite12.8%
Dermatological disorders
Sweating14.4%
Cardiovascular disorders
Tachycardia12.2%
Special Senses
Blurred vision10.0%

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see Warning and Precautions (5.2) and Drug Abuse and Dependence (9.3)].

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.

6.2 Postmarketing Experience

The following adverse reactions have been identified during postapproval use of XANAX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Endocrine disorders: Hyperprolactinemia

General disorders and administration site conditions: Edema peripheral

Hepatobiliary disorders: Hepatitis, hepatic failure

Investigations: Liver enzyme elevations

Psychiatric disorders: Hypomania, mania

Reproductive system and breast disorders: Gynecomastia, galactorrhea

Skin and subcutaneous tissue disorders: Photosensitivity reaction, angioedema, Stevens-Johnson syndrome

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