Xanax

Medical Reviewer: John P. Cunha, DO, FACOEP Last updated on RxList: 3/11/2021
Xanax Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Xanax?

Xanax (alprazolam) is a benzodiazepine used as an anti-anxiety medication prescribed to treat panic attacks and anxiety disorders. Xanax is available in generic form.

What Are Side Effects of Xanax?

Common side effects of Xanax include:

  • Drowsiness
  • Tiredness
  • Dizziness
  • Sleep problems (insomnia)
  • Memory problems
  • Poor balance or coordination
  • Slurred speech
  • Trouble concentrating
  • Irritability
  • Diarrhea
  • Constipation
  • Increased sweating
  • Headache
  • Nausea
  • Vomiting
  • Upset stomach
  • Blurred vision
  • Appetite or weight changes
  • Swelling in your hands or feet
  • Muscle weakness
  • Dry mouth
  • Stuffy nose
  • Loss of interest in sex

Dosage for Xanax

Treatment for patients with anxiety should be initiated with a dose of 0.25 to 0.5 mg Xanax given three times daily. Treatment of many panic disorders in patients has required the use of Xanax at doses greater than 4 mg daily.

What Drugs, Substances, or Supplements Interact with Xanax?

Xanax may interact with alcohol, other medicines that make you sleepy (such as cold or allergy medicine, other sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), birth control pills, cimetidine, cyclosporine, dexamethasone, ergotamine, imatinib, isoniazid, St. John's wort, antibiotics, antifungals, antidepressants, barbiturates, heart or blood pressure medications, HIV/AIDS medicines, seizure medications. Tell your doctor all medications and supplements you use.

Xanax During Pregnancy and Breastfeeding

Benzodiazepines, such as Xanax, can cause fetal abnormalities and should not be used in pregnancy or in nursing mothers. Xanax is excreted in human milk and can affect nursing infants. Breastfeeding while taking Xanax is not recommended.

Additional Information

Our Xanax Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Anxiety Disorder Pictures: Symptoms, Panic Attacks, and More with Pictures See Slideshow
Xanax Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Alprazolam can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if you have:

  • weak or shallow breathing;
  • a light-headed feeling, like you might pass out;
  • a seizure;
  • hallucinations, risk-taking behavior;
  • increased energy, decreased need for sleep;
  • racing thoughts, being agitated or talkative;
  • double vision; or
  • jaundice (yellowing of the skin or eyes).

The sedative effects of alprazolam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury.

Common side effects may include:

  • drowsiness; or
  • feeling light-headed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Xanax (Alprazolam)

QUESTION

Panic attacks are repeated attacks of fear that can last for several minutes. See Answer
Xanax Professional Information

SIDE EFFECTS

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

  • Risks from Concomitant Use with Opioids [see WARNINGS AND PRECAUTIONS]
  • Abuse, Misuse, and Addiction [see WARNINGS AND PRECAUTIONS]
  • Dependence and Withdrawal Reactions [see WARNINGS AND PRECAUTIONS]
  • Effects on Driving and Operating Machinery [see WARNINGS AND PRECAUTIONS]
  • Neonatal Sedation and Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]
  • Patients with Depression [see WARNINGS AND PRECAUTIONS]
  • Risks in Patients with Impaired Respiratory Function [see WARNINGS AND PRECAUTIONS]

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
Drowsiness 41% 22%
Light-headedness 21% 19%
Dizziness 2% 1%
Akathisia 2% 1%
Gastrointestinal disorders
Dry mouth 15% 13%
Increased salivation 4% 2%
Cardiovascular disorders
Hypotension 5% 2%
Skin and subcutaneous tissue disorders
Dermatitis/allergy 4% 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
Drowsiness 77% 43%
Fatique and Tiredness 49% 42%
Impaired Coordination 40% 18%
Irritability 33% 30%
Memory Impairment 33% 22%
Cognitive Disorder 29% 21%
Decreased Libido 14% 8%
Dysartharia 23% 6%
Confusional state 10% 8%
Increased libido 8% 4%
Change in libido (not specified) 7% 6%
Disinhibition 3% 2%
Talkativeness 2% 1%
Derealization 2% 1%
Gastrointestinal disorders
Constipation 26% 15%
Increased salivation 6% 4%
Skin and subcutaneous tissue disorders
Rash 11% 8%
Other
Increased appetite 33% 23%
Decreased appetite 28% 24%
Weight gain 27% 18%
Weight loss 23% 17%
Micturition difficulties 12% 9%
Menstrual disorders 11% 9%
Sexual dysfunction 7% 4%
Incontinence 2% 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
Nervous system disorders
Insomnia 29.5%
Light-headedness 19.3%
Abnormal involuntary movement 17.3%
Headache 17.0%
Muscular twitching 6.9%
Impaired coordination 6.6%
Muscle tone disorders 5.9%
Weakness 5.8%
Psychiatric disorders
Anxiety 19.2%
Fatigue and Tiredness 18.4%
Irritability 10.5%
Cognitive disorder 10.3%
Memory impairment 5.5%
Depression 5.1%
Confusional state 5.0%
Gastrointestinal disorders
Nausea/Vomiting 16.5%
Diarrhea 13.6%
Decreased salivation 10.6%
Metabolism and nutrition disorders
Weight loss 13.3%
Decreased appetite 12.8%
Dermatological disorders
Sweating 14.4%
Cardiovascular disorders
Tachycardia 12.2%
Special Senses
Blurred vision 10.0%
n=number of patients.

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of XANAX [see WARNINGS AND PRECAUTIONS and Drug Abuse And Dependence].

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.

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

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With XANAX

Table 4 includes clinically significant drug interactions with XANAX [see CLINICAL PHARMACOLOGY].

Table 4: Clinically Significant Drug Interactions with XANAX

Opioids
Clinical implication The concomitant use of benzodiazepines and opioids increases the risk of respiratory depression because of actions at different receptor sites in the CNS that control respiration. Benzodiazepines interact at gamma-aminobutyric acid(GABAA) sites and opioids interact primarily at mu receptors. When benzodiazepines and opioids are combined, the potential for benzodiazepines to significantly worsen opioid-related respiratory depression exists.
Prevention or management Limit dosage and duration of concomitant use of XANAX and opioids, and monitor patients closely for respiratory depression and sedation [see WARNINGS AND PRECAUTIONS].
Examples Morphine, buprenorphine, hydromorphone, oxymorphone, oxycodone, fentanyl, methadone, alfentanil, butorpenol, codeine, dihydrocodeine, meperidine, pentazocine, remifentanil, sufentanil, tapentadol, tramadol.
CNS Depressants
Clinical implication The benzodiazepines, including alprazolam, produce additive CNS depressant effects when coadministered with other CNS depressants.
Prevention or management Limit dosage and duration of XANAX during concomitant use with CNS depressants [see WARNINGS AND PRECAUTIONS].
Examples Psychotropic medications, anticonvulsants, antihistaminics, ethanol, and other drugs which themselves produce CNS depression.
Strong Inhibitors of CYP3A (except ritonavir)
Clinical implication Concomitant use of XANAX with strong CYP3A inhibitors has a profound effect on the clearance of alprazolam, resulting in increased concentrations of alprazolam and increased risk of adverse reactions [see CLINICAL PHARMACOLOGY].
Prevention or management Concomitant use of XANAX with a strong CYP3A4 inhibitor (except ritonavir) is contraindicated [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Examples Ketoconazole, itraconazole, clarithromycin
Moderate or Weak Inhibitors of CYP3A
Clinical implication Concomitant use of XANAX with CYP3A inhibitors may increase the concentrations of XANAX, resulting in increased risk of adverse reactions of alprazolam [see CLINICAL PHARMACOLOGY].
Prevention or management Avoid use and consider appropriate dose reduction when XANAX is coadministered with a moderate or weak CYP3A inhibitor [see WARNINGS AND PRECAUTIONS].
Examples Nefazodone, fluvoxamine, cimetidine, erythromycin
CYP3A Inducers
Clinical implication Concomitant use of CYP3A inducers can increase alprazolam metabolism and therefore can decease plasma levels of alprazolam [see CLINICAL PHARMACOLOGY].
Prevention or management Caution is recommended during coadministration with XANAX.
Examples Carbamazepine, phenytoin
Ritonavir
Clinical implication Interactions involving ritonavir and alprazolam are complex and time dependent. Short term administration of ritonavir increased alprazolam exposure due to CYP3A4 inhibition. Following long term treatment of ritonavir (>10 to 14 days), CYP3A4 induction offsets this inhibition. Alprazolam exposure was not meaningfully affected in the presence of ritonavir.
Prevention or management Reduce XANAX dosage when ritonavir and XANAX are initiated concomitantly, or when ritonavir is added to a regimen where XANAX is stabilized.
Increase XANAX dosage to the target dosage after 10 to 14 days of dosing ritonavir and XANAX concomitantly. No dosage adjustment of XANAX is necessary in patients receiving ritonavir for more than 10 to14 days [see DOSAGE AND ADMINISTRATION].
Concomitant use of XANAX with a strong CYP3A inhibitor, except ritonavir, is contraindicated [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS].
Digoxin
Clinical implication Increased digoxin concentrations have been reported when alprazolam was given, especially in geriatric patients( >65 years of age).
Prevention or management In patients on digoxin therapy, measure serum digoxin concentrations before initiating XANAX. Continue monitoring digoxin serum concentration and toxicity frequently. Reduce the digoxin dose if necessary.

Drug/Laboratory Test Interactions

Although interactions between benzodiazepines and commonly employed clinical laboratory tests have occasionally been reported, there is no consistent pattern for a specific drug or specific test.

Drug Abuse And Dependence

Controlled Substance

XANAX contains alprazolam, which is a Schedule IV controlled substance.

Abuse

XANAX is a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction.

Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders [see WARNINGS AND PRECAUTIONS].

The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo.

The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol).

Dependence

XANAX may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use [see WARNINGS AND PRECAUTIONS].

To reduce the risk of withdrawal reactions, use a gradual taper to discontinue XANAX or reduce the dosage [see DOSAGE AND ADMINISTRATION, WARNINGS AND PRECAUTIONS].

Acute Withdrawal Signs And Symptoms

Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures, and suicidality.

Protracted Withdrawal Syndrome

Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used.

Tolerance

Tolerance to XANAX may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of XANAX may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Read the entire FDA prescribing information for Xanax (Alprazolam)

© Xanax Patient Information is supplied by Cerner Multum, Inc. and Xanax Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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