IMPORTANT SAFETY INFORMATION AND INDICATIONS

What is the most important information I should know about XANAX?

  • XANAX is a benzodiazepine medicine. Taking benzodiazepines with opioid medicines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, breathing problems (respiratory depression), coma, and death.

    Get emergency help right away if any of the following happens:

    • Shallowed or slowed breathing
    • Breathing stops (which may lead to the heart stopping)
    • Excessive sleepiness (sedation)
  • Do not drive or operate heavy machinery until you know how taking XANAX with opioids affects you.

  • There is a risk of abuse, misuse, and addiction with XANAX, which can lead to overdose and serious side effects including coma and death, delirium, paranoia, suicidal thoughts or actions, seizures, and difficulty breathing. You can develop an addiction even if you take XANAX as prescribed by your healthcare provider.
  • XANAX can cause physical dependence and withdrawal reactions. Do not suddenly stop taking XANAX as it may lead to serious and life-threatening side effects, including unusual movements, responses, or expressions, seizures, sudden and severe mental or nervous system changes, depression, seeing or hearing things that others do not, an extreme increase in activity or talking, losing touch with reality, and suicidal thoughts or actions.

CALL YOUR HEALTHCARE PROVIDER OR GO TO THE HOSPITAL EMERGENCY ROOM RIGHT AWAY IF YOU GET ANY OF THE ABOVE LIFE-THREATENING OR SERIOUS SIDE EFFECTS.

XANAX is a federal controlled substance (C-IV) because it can be abused or lead to dependence. Keep XANAX in a safe place to prevent misuse and abuse. It is not known if XANAX is safe and effective in children.

Do not take XANAX if you are allergic to alprazolam, other benzodiazepines, or any of the ingredients in XANAX. Do not take XANAX if you are taking antifungal treatments, including ketoconazole or itraconazole.

Before you take XANAX, tell your healthcare provider about all your medical conditions, including if you:

  • Have or have had depression, mood problems, or suicidal thoughts or behavior.
  • Have liver or kidney problems.
  • Have lung disease or breathing problems.
  • Are pregnant or plan to become pregnant. Taking XANAX late in pregnancy may cause your baby to have symptoms of sedation and/or withdrawal symptoms. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with XANAX.
  • Are breastfeeding or plan to breastfeed. XANAX passes into your breast milk. Breastfeeding is not recommended during treatment with XANAX.

Tell your healthcare provider about all the medicines you take, including prescriptions and over-the-counter medicines, vitamins, and herbal supplements. Taking XANAX with certain other medicines can cause side effects or affect how well XANAX or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider.

Take XANAX exactly as your healthcare provider prescribed.

  • Do not take more XANAX than prescribed or take XANAX for longer than prescribed.
  • Do not share your XANAX with other people.
  • Keep XANAX in a safe place and away from children.

XANAX may cause serious side effects, including:

  • See “What is the most important information I should know about XANAX?”
  • Seizures. Stopping XANAX can cause seizures and seizures that will not stop (status epilepticus).
  • Mania. XANAX may cause an increase in activity and talking (hypomania and mania) in people who have depression.
  • XANAX can make you sleepy or dizzy and can slow your thinking and motor skills. Do not drive, operate heavy machinery, or do other dangerous activities until you know how XANAX affects you.
  • Do not drink alcohol or take other drugs that may make you sleepy or dizzy while taking XANAX without first talking to your healthcare provider. When taken with alcohol or drugs that cause sleepiness or dizziness, such as opioid medications or sleeping pills, XANAX may make your sleepiness or dizziness much worse.

The most common side effects of XANAX include problems with coordination, hypotension, trouble saying words clearly, and changes in sex drive (libido).

INDICATIONS

XANAX (alprazolam) is indicated to treat anxiety disorders and for the short-term relief of symptoms of anxiety. XANAX is also indicated to treat panic disorder with or without a fear of places and situations that might cause panic, helplessness, or embarrassment (agoraphobia).

Please see Full Prescribing Information, including BOXED WARNING, and Medication Guide.