XANAX SIDE EFFECTS
- Generic Name: alprazolam
- Brand Name: Xanax
- Drug Class: , Anxiolytics, Benzodiazepines
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 .