XANAX SIDE EFFECTS

  • Generic Name: alprazolam
  • Brand Name: Xanax
  • Drug Class: , Anxiolytics, Benzodiazepines
Last updated on MDtodate: 10/7/2022

SIDE EFFECTS

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

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

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.

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

 

SRC: NLM .