Xanax XR Side Effects

Generic Name: alprazolam

Please note - some side effects for Xanax XR may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Xanax XR - for the Consumer

Xanax XR Extended-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Xanax XR Extended-Release Tablets:

Changes in appetite; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; light-headedness; nausea; tiredness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur when using Xanax XR Extended-Release Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blurred vision; burning, numbness, or tingling; chest pain; confusion; dark urine; decreased coordination; decreased urination; fainting; fast or irregular heartbeat; hallucinations; loss of balance or muscle control; memory or attention problems; menstrual changes; muscle twitching; new or worsening mental or mood changes (eg, depression, irritability, anxiety; exaggerated feeling of well-being); overstimulation; red, swollen blistered, or peeling skin; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath or trouble breathing; suicidal thoughts or actions; tremor; trouble speaking; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Xanax XR Side Effects - for the Professional

Xanax XR

The information included in the subsection on Adverse Events Observed in Short-Term, Placebo-Controlled Trials with Xanax XR Tablets is based on pooled data of five 6- and 8-week placebo-controlled clinical studies in panic disorder.

Adverse event reports were elicited either by general inquiry or by checklist, and were recorded by clinical investigators using terminology of their own choosing. The stated frequencies of adverse events represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse event of the type listed. An event was considered treatment emergent if it occurred for the first time or worsened during therapy following baseline evaluation. In the tables and tabulations that follow, standard MedDRA terminology (version 4.0) was used to classify reported adverse events.

Adverse Events Observed in Short-Term, Placebo-Controlled Trials of Xanax XR

Adverse Events Reported as Reasons for Discontinuation of Treatment in Placebo-Controlled Trials

Approximately 17% of the 531 patients who received Xanax XR in placebo-controlled clinical trials for panic disorder had at least one adverse event that led to discontinuation compared to 8% of 349 placebo-treated patients. The most common events leading to discontinuation and considered to be drug-related (ie, leading to discontinuation in at least 1% of the patients treated with Xanax XR at a rate at least twice that of placebo) are shown in the following table.

Common Adverse Events Leading to Discontinuation of Treatment in Placebo-Controlled Trials

System Organ Class/Adverse Event	Percentage of Patients Discontinuing Due to Adverse Events
	Xanax XR (n=531)	Placebo (n=349)
Nervous system disorders
Sedation	7.5	0.6
Somnolence	3.2	0.3
Dysarthria	2.1	0
Coordination abnormal	1.9	0.3
Memory impairment	1.5	0.3
General disorders/administration site conditions
Fatigue	1.7	0.6
Psychiatric disorders
Depression	2.5	1.2

Adverse Events Occurring at an Incidence of 1% or More Among Patients Treated with Xanax XR

The prescriber should be aware that adverse event incidence cannot be used to predict the incidence of adverse events in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with event incidence obtained from other clinical investigations involving different treatments, uses, and investigators. The cited values, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the adverse event incidence rate in the population studied.

The following table shows the incidence of treatment-emergent adverse events that occurred during 6- to 8-week placebo-controlled trials in 1% or more of patients treated with Xanax XR where the incidence in patients treated with Xanax XR was greater than the incidence in placebo-treated patients. The most commonly observed adverse events in panic disorder patients treated with Xanax XR (incidence of 5% or greater and at least twice the incidence in placebo patients) were: sedation, somnolence, memory impairment, dysarthria, coordination abnormal, ataxia, libido decreased.

Treatment-Emergent Adverse Events: Incidence in Short-Term, Placebo-Controlled Clinical Trials with Xanax XR
System Organ Class/Adverse Event	Percentage of Patients Reporting Adverse Event
	Xanax XR (n=531)	Placebo (n=349)
Nervous system disorders
Sedation	45.2	22.6
Somnolence	23.0	6.0
Memory impairment	15.4	6.9
Dysarthria	10.9	2.6
Coordination abnormal	9.4	0.9
Mental impairment	7.2	5.7
Ataxia	7.2	3.2
Disturbance in attention	3.2	0.6
Balance impaired	3.2	0.6
Paresthesia	2.4	1.7
Dyskinesia	1.7	1.4
Hypoesthesia	1.3	0.3
Hypersomnia	1.3	0
General disorders/administration site conditions
Fatigue	13.9	9.2
Lethargy	1.7	0.6
Infections and infestations
Influenza	2.4	2.3
Upper respiratory tract infections	1.9	1.7
Psychiatric disorders
Depression	12.1	9.2
Libido decreased	6.0	2.3
Disorientation	1.5	0
Confusion	1.5	0.9
Depressed mood	1.3	0.3
Anxiety	1.1	0.6
Metabolism and nutrition disorders
Appetite decreased	7.3	7.2
Appetite increased	7.0	6.0
Anorexia	1.5	0
Gastrointestinal disorders
Dry mouth	10.2	9.7
Constipation	8.1	4.3
Nausea	6.0	3.2
Pharyngolaryngeal pain	3.2	2.6
Investigations
Weight increased	5.1	4.3
Weight decreased	4.3	3.7
Injury, poisoning, and procedural complications
Road traffic accident	1.5	0
Reproductive system and breast disorders
Dysmenorrhea	3.6	2.9
Sexual dysfunction	2.4	1.1
Premenstrual syndrome	1.7	0.6
Musculoskeletal and connective tissue disorders
Arthralgia	2.4	0.6
Myalgia	1.5	1.1
Pain in limb	1.1	0.3
Vascular disorders
Hot flushes	1.5	1.4
Respiratory, thoracic, and mediastinal disorders
Dyspnea	1.5	0.3
Rhinitis allergic	1.1	0.6
Skin and subcutaneous tissue disorders
Pruritis	1.1	0.9

Other Adverse Events Observed During the Premarketing Evaluation of Xanax XR Tablets

Following is a list of MedDRA terms that reflect treatment-emergent adverse events reported by 531 patients with panic disorder treated with Xanax XR. All potentially important reported events are included except those already listed in the above table or elsewhere in labeling, those events for which a drug cause was remote, those event terms that were so general as to be uninformative, and those events that occurred at rates similar to background rates in the general population. It is important to emphasize that, although the events reported occurred during treatment with Xanax XR, they were not necessarily caused by the drug. Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring on 1 or more occasions in at least l/l00 patients; infrequent adverse events are those occurring in less than l/100 patients but at least l/1000 patients; rare events are those occurring in fewer than l/1000 patients.

Cardiac disorders: Frequent: palpitation; Infrequent: sinus tachycardia

Ear and Labyrinth disorders: Frequent: Vertigo; Infrequent: tinnitus, ear pain

Eye disorders: Frequent: blurred vision; Infrequent: mydriasis, photophobia

Gastrointestinal disorders: Frequent: diarrhea, vomiting, dyspepsia, abdominal pain; Infrequent: dysphagia, salivary hypersecretion

General disorders and administration site conditions: Frequent: malaise, weakness, chest pains; Infrequent: fall, pyrexia, thirst, feeling hot and cold, edema, feeling jittery, sluggishness, asthenia, feeling drunk, chest tightness, increased energy, feeling of relaxation, hangover, loss of control of legs, rigors

Musculoskeletal and connective tissue disorders: Frequent: back pain, muscle cramps, muscle twitching

Nervous system disorders: Frequent: headache, dizziness, tremor; Infrequent: amnesia, clumsiness, syncope, hypotonia, seizures, depressed level of consciousness, sleep apnea syndrome, sleep talking, stupor

Psychiatric system disorders: Frequent: irritability, insomnia, nervousness, derealization, libido increased, restlessness, agitation, depersonalization, nightmare; Infrequent: abnormal dreams, apathy, aggression, anger, bradyphrenia, euphoric mood, logorrhea, mood swings, dysphonia, hallucination, homicidal ideation, mania, hypomania, impulse control, psychomotor retardation, suicidal ideation

Renal and urinary disorders: Frequent: difficulty in micturition; Infrequent: urinary frequency, urinary incontinence

Respiratory, thoracic, and mediastinal disorders: Frequent: nasal congestion, hyperventilation; Infrequent: choking sensation, epistaxis, rhinorrhea

Skin and subcutaneous tissue disorders: Frequent: sweating increased; Infrequent: clamminess, rash, urticaria

Vascular disorders: Infrequent: hypotension

The categories of adverse events reported in the clinical development program for XANAX Tablets in the treatment of panic disorder differ somewhat from those reported for Xanax XR Tablets because the clinical trials with XANAX Tablets and Xanax XR Tablets used different standard medical nomenclature for reporting the adverse events. Nevertheless, the types of adverse events reported in the clinical trials with XANAX Tablets were generally the same as those reported in the clinical trials with Xanax XR Tablets.

Discontinuation-Emergent Adverse Events Occurring at an Incidence of 5% or More Among Patients Treated with Xanax XR

The following table shows the incidence of discontinuation-emergent adverse events that occurred during short-term, placebo-controlled trials in 5% or more of patients treated with Xanax XR where the incidence in patients treated with Xanax XR was two times greater than the incidence in placebo-treated patients.

Discontinuation-Emergent Symptoms: Incidence in Short-Term, Placebo-Controlled Trials with Xanax XR
System Organ Class/Adverse Event	Percentage of Patients Reporting Adverse Event
	Xanax XR (n=422)	Placebo (n=261)
Nervous system disorders
Tremor	28.2	10.7
Headache	26.5	12.6
Hypoesthesia	7.8	2.3
Paraesthesia	7.1	2.7
Psychiatric disorders
Insomnia	24.2	9.6
Nervousness	21.8	8.8
Depression	10.9	5.0
Derealization	8.0	3.8
Anxiety	7.8	2.7
Depersonalization	5.7	1.9
Gastrointestinal disorders
Diarrhea	12.1	3.1
Respiratory, thoracic and mediastinal disorders
Hyperventilation	8.5	2.7
Metabolism and nutrition disorders
Appetite decreased	9.5	3.8
Musculosketal and connective tissue disorders
Muscle twitching	7.4	2.7
Vascular disorders
Hot flushes	5.9	2.7

There have also been reports of withdrawal seizures upon rapid decrease or abrupt discontinuation of alprazolam.

To discontinue treatment in patients taking Xanax XR Tablets, the dosage should be reduced slowly in keeping with good medical practice. It is suggested that the daily dosage of Xanax XR Tablets be decreased by no more than 0.5 mg every three days. Some patients may benefit from an even slower dosage reduction. In a controlled postmarketing discontinuation study of panic disorder patients which compared this recommended taper schedule with a slower taper schedule, no difference was observed between the groups in the proportion of patients who tapered to zero dose; however, the slower schedule was associated with a reduction in symptoms associated with a withdrawal syndrome.

As with all benzodiazepines, 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.

Post Introduction Reports

Various adverse drug reactions have been reported in association with the use of XANAX Tablets since market introduction. The majority of these reactions were reported through the medical event voluntary reporting system. Because of the spontaneous nature of the reporting of medical events and the lack of controls, a causal relationship to the use of XANAX Tablets cannot be readily determined. Reported events include: gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea.

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Side Effects by Body System - for Healthcare Professionals

Nervous system

Nervous system side effects reported during treatment for anxiety disorders have included drowsiness (41%), lightheadedness (20.8%), depression (13.9%), headache (12.9%), confusion (9.9%), insomnia (8.9%), nervousness (4.1%), syncope (3.1%), dizziness (1.8%), and akathisia (1.6%).

Nervous system side effects reported during treatment for panic disorder have included drowsiness (76.8%), fatigue and tiredness (48.6%), impaired coordination (40.1%), irritability (33.1%), memory impairment (33.1%), lightheaded/dizziness (29.8%), insomnia (29.4%), headache (29.2%), cognitive disorder (28.8%), dysarthria (23.3%), anxiety (16.6%), abnormal involuntary movement (14.8%), decreased libido (14.4%), confused state (10.4%), muscular twitching (7.9%), increased libido (7.7%), change in libido (7.1%), weakness (7.1%), muscle tone disorders (6.3%), syncope (3.8%), akathisia (3.0%), agitation (2.9%), disinhibition (2.7%), paresthesia (2.4%), talkativeness (2.2%), vasomotor disturbances (2.0%), derealization (1.9%), dream abnormalities (1.8%), fear (1.4%), feeling warm (1.3%).

Seizures, hallucinations, and depersonalization have been reported in less than 1% of patients. Amnesia, psychomotor impairment, anterograde memory loss, and ataxia have also been reported.

Elderly patients and/or patients with liver dysfunction may be particularly sensitive to central nervous system side effects. The smallest effective dose should be used in the elderly to avoid the development of ataxia and oversedation.

One study has reported that the frequency of ataxia in patients treated for panic disorder ranges between 17% and 24%. Another study has reported that patients treated acutely with alprazolam by intravenous administration experience a 25% to 30% decrease in whole brain cerebral blood flow. The decrease in blood flow is associated with memory impairment, a decrease in plasma epinephrine and a decrease in self-rated alertness. After a week of daily alprazolam therapy, most of the subjects developed tolerance to these effects.

A 64-year-old man with a history of renal insufficiency was diagnosed with nonconvulsive status epilepticus following abrupt withdrawal of yearlong alprazolam therapy at dosage 1 mg orally every night. The patient recovered with short-term oral anticonvulsant therapy and reinstitution of alprazolam followed by a more gradual taper of alprazolam therapy.

The following nervous system side effects have been reported to result in discontinuation of treatment in over 5% of patients and at a greater rate than placebo: insomnia (29.5%), lightheadedness (19.3%), anxiety (19.2%), fatigue and tiredness (18.4%), abnormal involuntary movement (17.3%), headache (17.0%), irritability (10.5%), cognitive disorder (10.3%), muscular twitching (6.9%), impaired coordination (6.6%), muscle tone disorders (5.9%), and weakness (5.8%), memory impairment (5.5%), depression (5.1%), and confused state (5.0%).

There have been reports of seizures in patients following rapid decrease in dose or abrupt withdrawal of treatment with alprazolam. The risk of withdrawal seizures may be higher in patients receiving doses greater than 4 mg per day.

Other

In addition, some investigators have reported the following effects as manifestations of alprazolam withdrawal: confusion, clouded sensorium, heightened sensory perception, dysosmia, paresthesias, diarrhea, and decreased appetite. Psychosensory symptoms such as depersonalization, derealization, and perceptual distortion have been reported as being unique to the withdrawal syndrome.

Some investigators have suggested that the incidence of withdrawal symptoms may be related to the rapidity of dosage tapering.

A recent review of both human and nonhuman experience with alprazolam abuse potential has concluded that the abuse liability of alprazolam is probably not greater than other commonly used benzodiazepines.

Other side effects reported during treatment for anxiety disorder have included weight gain (2.7%) and weight loss (2.3%).

Other side effects reported during treatment for panic disorder have included tinnitus (6.6%), increased appetite (32.7%), decreased appetite (27.8%), weight gain (27.2%), weight loss (22.6%), edema (4.9%), and infection (1.3%).

Other side effects have included withdrawal symptoms following either abrupt cessation or fast tapering of alprazolam. Withdrawal symptoms may include agitation, restlessness, anxiety, insomnia, convulsions, tremor, abdominal cramps, blurred vision, vomiting, and sweating. The incidence is unknown but may be higher than for other benzodiazepines.

Ocular

Ocular side effects have included blurred vision (6.2% to 21%) and acute worsening of narrow angle glaucoma. Diplopia has been reported rarely (less than 1%).

Blurred vision appears to be the reason for discontinuation of therapy in 10.0% of patients.

Psychiatric

Psychiatric side effects reported during treatment for panic disorder have included major depression (12.1% to 13.8%).

Hypomania, mania, and aggression have also been reported.

Hepatic

Hepatic side effects reported in less than 1% of patients have included elevated bilirubin, elevated hepatic enzymes, and jaundice.

Hepatitis and hepatic failure have also been reported.

Genitourinary

Genitourinary side effects reported during treatment of panic disorder have included micturition difficulties (12.2%), menstrual disorders (10.4%), sexual dysfunction (4.9%), and incontinence (1.5%).

Hyperlactatemia, gynecomastia, and galactorrhea have also been reported.

Gastrointestinal

Gastrointestinal side effects which resulted in discontinuation of treatment in over 5% of patients and at a greater rate than placebo have included nausea/vomiting (16.5%), diarrhea (13.6%), and decreased salivation (10.6%).

Gastrointestinal side effects reported during treatment for anxiety disorders have included dry mouth (14.7%), constipation (10.4%), nausea/vomiting (9.6%), and increased salivation (4.2%).

Gastrointestinal side effects reported during treatment for panic disorders have included decreased salivation (32.8%), constipation (26.2%), nausea/vomiting (22%), diarrhea (20.6%), abdominal distress (18.3%), and increased salivation (5.6%).

Alteration of taste has been reported in less than 1% of patients.

General

In general, if they occur, side effects are observed at the beginning of therapy and usually resolve with continuation of therapy.

Postmarketing side effects have included gastrointestinal disorder, hypomania, mania, liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, angioedema, peripheral edema, hyperprolactinemia, gynecomastia, and galactorrhea.

Dermatologic

Dermatologic side effects reported during treatment for anxiety disorders have included dermatitis/allergy (3.8%).

Dermatologic side effects reported during treatment for panic disorder have included sweating (15.1%) and rash (10.8%).

Dermatologic side effects have rarely included photosensitivity. Stevens-Johnson syndrome has also been reported.

Dermatologic side effects which resulted in discontinuation of treatment in over 5% of patients and at a greater rate than placebo have included sweating (14.4%).

Respiratory

Respiratory side effects reported during treatment for anxiety disorder have included nasal congestion (7.3%).

Respiratory side effects reported during treatment for panic disorder have included nasal congestion (17.4%), hyperventilation (9.7%), and upper respiratory infection (4.3%).

Respiratory side effects associated with patients with chronic obstructive pulmonary disease have included decreased pO2 and increased pCO2.

Endocrine

A short study on 58 patients with poor glycemic control concluded alprazolam improved glucose regulation and the effect was not directly related to changes in anxiety.

Endocrine side effects have included improved glucose regulation.

Cardiovascular

Cardiovascular side effects which resulted in discontinuation of treatment in over 5% of patients and at a greater rate than placebo have included tachycardia (12.2%).

Cardiovascular side effects reported during treatment for anxiety disorders have included tachycardia/palpitation (7.7%) and hypotension (4.7%).

Cardiovascular side effects reported during treatment for panic disorder have included tachycardia (15.4%) and chest pain (10.6%).

Musculoskeletal

Musculoskeletal side effects reported during treatment for anxiety disorders have included rigidity (4.2%) and tremor (4.0%).

Musculoskeletal side effects reported during treatment for panic disorders have included muscular cramps (2.4%) and muscular stiffness (2.2%).

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