In Summary

Commonly reported side effects of alprazolam include: ataxia, cognitive dysfunction, constipation, depression, difficulty in micturition, drowsiness, dysarthria, fatigue, headache, memory impairment, menstrual disease, nervousness, sedated state, skin rash, tremor, weight gain, weight loss, anxiety, blurred vision, diarrhea, insomnia, decreased libido, increased appetite, irritability, and decreased appetite. Other side effects include: depersonalization, hyperventilation, hypoesthesia, hypotension, paresthesia, sexual disorder, sialorrhea, muscle twitching, and increased libido. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to alprazolam: oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

Along with its needed effects, alprazolam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking alprazolam:

More common

• Being forgetful
• changes in patterns and rhythms of speech
• clumsiness or unsteadiness
• difficulty with coordination
• discouragement
• drowsiness
• feeling sad or empty
• irritability
• lack of appetite
• lightheadedness
• loss of interest or pleasure
• relaxed and calm
• shakiness and unsteady walk
• sleepiness or unusual drowsiness
• slurred speech
• tiredness
• trouble concentrating
• trouble performing routine tasks
• trouble sleeping
• trouble speaking
• unsteadiness, trembling, or other problems with muscle control or coordination
• unusual tiredness or weakness

Less common

• Abdominal or stomach pain
• blurred vision
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
• changes in behavior
• chills
• clay-colored stools
• confusion about identity, place, and time
• cough
• dark urine
• decrease in frequency of urination
• decrease in urine volume
• diarrhea
• difficult or labored breathing
• difficulty in passing urine (dribbling)
• difficulty with concentration
• difficulty with moving
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• ear congestion
• environment seems unreal
• fainting
• fear or nervousness
• feeling of unreality
• feeling warm
• fever
• general feeling of discomfort or illness
• headache
• hyperventilation
• inability to move the eyes
• inability to sit still
• increased blinking or spasms of the eyelid
• irregular heartbeats
• itching or rash
• joint pain
• lack or loss of self-control
• loss of bladder control
• loss of coordination
• loss of memory
• loss of voice
• mood or mental changes
• muscle aching or cramping
• muscle pain or stiffness
• muscle weakness
• nasal congestion
• nausea
• need to keep moving
• painful urination
• problems with memory
• restlessness
• runny nose
• seeing, hearing, or feeling things that are not there
• seizures
• sense of detachment from self or body
• shaking
• shivering
• sneezing
• sore throat
• sticking out of the tongue
• sweating
• swollen joints
• talkativeness
• tightness in the chest
• trouble with balance
• twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unpleasant breath odor
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• unusual facial expressions
• unusually deep sleep
• unusually long duration of sleep
• vomiting of blood
• yellow eyes or skin

Rare

• Actions that are out of control
• attack, assault, or force
• chest pain
• continuing ringing or buzzing or other unexplained noise in the ears
• decreased awareness or responsiveness
• deep or fast breathing with dizziness
• ear pain
• false or unusual sense of well-being
• fast, irregular, pounding, or racing heartbeat or pulse
• feeling jittery
• feeling unusually cold
• generalized slowing of mental and physical activity
• hearing loss
• hoarseness
• lack of feeling or emotion
• loss of control of the legs
• loss of strength or energy
• nightmares
• numbness of the feet, hands, and around mouth
• severe sleepiness
• shakiness in the legs, arms, hands, or feet
• sleep talking
• swelling
• talking, feeling, and acting with excitement
• thoughts of killing oneself
• uncaring
• unusual weak feeling
• voice changes

Incidence not known

• General tiredness and weakness
• light-colored stools
• stomach pain, continuing
• upper right abdominal or stomach pain

Some side effects of alprazolam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Absent, missed, or irregular menstrual periods
• decreased appetite
• decreased interest in sexual intercourse
• decreased sexual performance or desire abnormal ejaculation
• difficulty having a bowel movement (stool)
• inability to have or keep an erection
• increased appetite
• increased in sexual ability, desire, drive, or performance
• increased interest in sexual intercourse
• increased weight
• loss in sexual ability, desire, drive, or performance
• stopping of menstrual bleeding
• watering of the mouth
• weight loss

Less common

• Abdominal or bloating and cramping
• blistering, crusting, irritation, itching, or reddening of the skin
• change in taste bad unusual or unpleasant (after) taste
• cracked, dry, or scaly skin
• cramps
• double vision
• feeling of warmth
• heavy bleeding
• menstrual changes
• pain
• pelvic pain
• redness of the face, neck, arms, and occasionally, upper chest
• seeing double
• sudden sweating
• unexplained runny nose or sneezing

Rare

• Acid or sour stomach
• belching
• bigger, dilated, or enlarged pupils (black part of the eye)
• change in color vision
• difficulty seeing at night
• feeling of constant movement of self or surroundings
• feeling of relaxation
• heartburn
• hives or welts
• increased sensitivity of the eyes to sunlight
• indigestion
• redness of the skin
• runny nose
• sensation of spinning
• stomach discomfort, upset, or pain
• stuffy nose

Incidence not known

• Blistering, peeling, or loosening of the skin
• red, irritated eyes
• red skin lesions, often with a purple center
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the breasts or breast soreness in both females and males
• unexpected or excess milk flow from the breasts

For Healthcare Professionals

Applies to alprazolam: compounding powder, oral concentrate, oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release

General

Immediate-release formulations: The most commonly reported side effects included drowsiness/sedation, fatigue and tiredness, impaired coordination, memory impairment, and irritability.

Extended-release tablets: The most commonly reported side effects included sedation, tremor, headache, insomnia, and somnolence.

Nervous system

Immediate-release formulations:

Very common (10% or more): Sedation (up to 77%), drowsiness (up to 76.8%), impaired coordination (up to 40.1%), memory impairment (up to 33.1%), dizziness (up to 29.8%), lightheadedness (up to 29.8%), headache (up to 29.2%), cognitive disorder (up to 29%), dysarthria (up to 23.3%), abnormal voluntary movement (up to 17.3%)

Common (1% to 10%): Abnormal coordination, akathisia, ataxia, attention disturbance, balance disorder, hypersomnia, lethargy, paresthesia, somnolence, syncope, tremor, vasomotor disturbances

Uncommon (0.1% to 1%): Amnesia, autonomic manifestations, coordination disorders, intellectual impairment, stimulation

Frequency not reported: Concentration difficulties, convulsions, dystonia, loss of coordination, seizures, sleepiness, slurred speech, taste alterations, transient amnesia, withdrawal seizures

Postmarketing reports: Autonomic nervous system imbalance, psychomotor hyperactivity

Extended-release tablets:

Very common (10% or more): Sedation (up to 45.2%), tremor (up to 28.2%), headache (up to 26.5%), somnolence (up to 23%), memory impairment (up to 15.4%), dysarthria (up to 10.9%)

Common (1% to 10%): Abnormal coordination, ataxia, balance impaired, disturbance in attention, dizziness, dyskinesia, hypersomnia, hypoesthesia, lethargy, mental impairment, paresthesia, vertigo

Uncommon (0.1% to 1%): Amnesia, clumsiness, depressed level of consciousness, hangover, hypotonia, stupor, syncope

Frequency not reported: Stimulation, withdrawal seizures

Other

Immediate-release formulations:

Very common (10% or more): Fatigue and tiredness (up to 49%)

Common (1% to 10%): Feeling warm, tinnitus, weakness

Frequency not reported: Rebound phenomena

Extended-release tablets:

Very common (10% or more): Fatigue (up to 13.9%)

Common (1% to 10%): Malaise, road traffic accident, weakness

Uncommon (0.1% to 1%): Asthenia, ear pain, fall, feeling drunk, feeling hot and cold, feeling jittery, feeling of relaxation, increased energy, loss of control of legs, pyrexia, rigors, sluggishness, tinnitus

Frequency not reported: Paradoxical reactions

Psychiatric

Immediate-release formulations:

Very common (10% or more): Irritability (up to 33.1%), insomnia (up to 29.5%), anxiety (up to 19.2%), decreased libido (up to 14%), depression (up to 13.9%), confusional state (up to 10.4%)

Common (1% to 10%): Agitation, change in libido (not specified), confusion, derealization, disinhibition, disorientation, dream abnormalities, fear, increased libido, nervousness, talkativeness

Uncommon (0.1% to 1%): Adverse behavioral effects, altered mood, concentration difficulties, hallucinations

Rare (0.01% to 0.1%): Hypomania, mania, other adverse behavioral effects

Frequency not reported: Abuse, aggressive or hostile behavior, aggressiveness/aggression, anterograde amnesia, delusion, depersonalization, dysphoria/mild dysphoria, hostility, inappropriate behavior, intrusive thoughts, nightmares, physical dependence, primary/secondary major depressive disorders, psychic dependence, psychoses, rage, restlessness, suicide, withdrawal symptoms

Postmarketing reports: Abnormal thinking, anger, libido disorder

Extended-release tablets:

Very common (10% or more): Insomnia (up to 24.2%), nervousness (up to 21.8%), depression (up to 12.1%)

Common (1% to 10%): Agitation, anxiety, confusion, depersonalization, depressed mood, derealization, disorientation, irritability, libido decreased/increased, nightmare, restlessness

Uncommon (0.1% to 1%): Abnormal dreams, aggression, anger, apathy, bradyphrenia, euphoric mood, hallucination, homicidal ideation, hypomania, impulse control, logorrhea, mania, mood swings, psychomotor retardation, sleep talking, suicidal ideation

Frequency not reported: Adverse behavioral effects, aggressive/hostile behavior, hostility, intrusive thoughts, other adverse behavioral effects, sleep disturbances, rage, withdrawal syndrome

Gastrointestinal

Immediate-release formulations:

Very common (10% or more): Decreased salivation (up to 32.8%), constipation (up to 26.2%), nausea (up to 22%), vomiting (up to 22%), diarrhea (up to 20.6%), abdominal distress (up to 18.3%), dry mouth (up to 15%)

Common (1% to 10%): Increased salivation

Uncommon (0.1% to 1%): Gastrointestinal symptoms/various gastrointestinal symptoms

Frequency not reported: Abdominal cramps

Postmarketing reports: Gastrointestinal disorder

Extended-release tablets:

Very common (10% or more): Diarrhea (up to 12.1%), dry mouth (up to 10.2%)

Common (1% to 10%): Abdominal pain, constipation, dyspepsia, nausea, vomiting

Uncommon (0.1% to 1%): Dysphagia, salivary hypersecretion

Postmarketing reports: Gastrointestinal disorder

Metabolic

Immediate-release formulations:

Very common (10% or more): Increased appetite (up to 33%), decreased appetite (up to 28%), weight gain (up to 27%), weight loss (up to 23%)

Frequency not reported: Anorexia

Extended-release tablets:

Common (1% to 10%): Anorexia, appetite decreased/increased, weight decreased/increased

Uncommon (0.1% to 1%): Thirst

Cardiovascular

Immediate-release formulations:

Very common (10% or more): Tachycardia (up to 15.4%), chest pain (up to 10.6%)

Common (1% to 10%): Edema, hypotension, palpitations

Postmarketing reports: Peripheral edema

Extended-release tablets:

Common (1% to 10%): Chest pain, hot flush, palpitations

Uncommon (0.1% to 1%): Chest tightness, edema, hypotension, sinus tachycardia

Postmarketing reports: Peripheral edema

Genitourinary

Immediate-release formulations:

Very common (10% or more): Micturition difficulties (up to 12.2%), menstrual disorders (up to 10.4%)

Common (1% to 10%): Incontinence, sexual dysfunction

Frequency not reported: Menstrual irregularities, urinary retention

Postmarketing reports: Galactorrhea

Extended-release tablets:

Common (1% to 10%): Difficulty in micturition, dysmenorrhea, premenstrual syndrome, sexual dysfunction

Uncommon (0.1% to 1%): Urinary frequency, urinary incontinence

Postmarketing reports: Galactorrhea

Dermatologic

Immediate-release formulations:

Very common (10% or more): Sweating (up to 15.1%), rash (up to 11%)

Common (1% to 10%): Dermatitis

Frequency not reported: Pruritus

Postmarketing reports: Photosensitivity reaction, Stevens-Johnson syndrome

Extended-release tablets:

Common (1% to 10%): Pruritus, sweating increased

Uncommon (0.1% to 1%): Clamminess, rash, urticaria

Postmarketing reports: Stevens-Johnson syndrome

Respiratory

Immediate-release formulations:

Very common (10% or more): Nasal congestion (up to 17.4%)

Common (1% to 10%): Hyperventilation, upper respiratory tract infection

Extended-release tablets:

Common (1% to 10%): Allergic rhinitis, dyspnea, hyperventilation, nasal congestion, pharyngolaryngeal pain, upper respiratory tract infections

Uncommon (0.1% to 1%): Choking sensation, dysphonia, epistaxis, rhinorrhea, sleep apnea syndrome

Ocular

Immediate-release formulations:

Very common (10% or more): Blurred vision (up to 21%)

Rare (0.01% to 0.1%): Increased intraocular pressure

Frequency not reported: Diplopia

Extended-release tablets:

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Mydriasis, photophobia

Musculoskeletal

Immediate-release formulations:

Common (1% to 10%): Muscle stiffness, muscle tone disorders, muscular cramps, muscular twitching, rigidity

Uncommon (0.1% to 1%): Muscular weakness

Frequency not reported: Musculoskeletal weakness

Extended-release tablets:

Common (1% to 10%): Arthralgia, back pain, muscle cramps, muscle twitching, myalgia, pain in limb

Frequency not reported: Increased muscle spasticity

Immunologic

Immediate-release formulations:

Common (1% to 10%): Infection

Extended-release tablets:

Common (1% to 10%): Influenza

Hypersensitivity

Immediate-release formulations:

Common (1% to 10%): Allergy

Postmarketing reports: Angioedema

Extended-release tablets:

Postmarketing reports: Angioedema

Hepatic

Immediate-release formulations:

Rare (0.01% to 0.1%): Abnormal hepatic function tests, jaundice

Frequency not reported: Elevated bilirubin, elevated hepatic enzymes

Postmarketing reports: Hepatic failure, hepatitis

Extended-release tablets:

Postmarketing reports: Hepatic failure, hepatitis, liver enzyme elevations

Endocrine

Immediate-release formulations:

Postmarketing reports: Gynecomastia, hyperprolactinemia

Extended-release tablets:

Postmarketing reports: Gynecomastia, hyperprolactinemia