Alprazolam Intensol Side Effects
Generic Name: alprazolam
Note: This document contains side effect information about alprazolam. Some of the dosage forms listed on this page may not apply to the brand name Alprazolam Intensol.
Some side effects of Alprazolam Intensol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to alprazolam: oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release
Along with its needed effects, alprazolam (the active ingredient contained in Alprazolam Intensol) 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
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- relaxed and calm
- shakiness and unsteady walk
- sleepiness or unusual drowsiness
- slurred speech
- trouble concentrating
- trouble in speaking
- trouble performing routine tasks
- trouble sleeping
- unsteadiness, trembling, or other problems with muscle control or coordination
- unusual tiredness or weakness
- Abdominal or stomach pain
- blurred vision
- body aches or pain
- burning, crawling, itching, numbness, prickling, "pins and needles, or tingling feelings
- changes in behavior
- clay-colored stools
- confusion about identity, place, and time
- dark urine
- decrease in frequency of urination
- decrease in urine volume
- difficult or labored breathing
- difficulty in moving
- difficulty in passing urine (dribbling)
- difficulty with concentration
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- dry mouth
- ear congestion
- environment seems unreal
- fear or nervousness
- feeling of unreality
- feeling warm
- general feeling of discomfort or illness
- inability to move eyes
- inability to sit still
- increased blinking or spasms of the eyelid
- irregular heartbeats
- 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
- need to keep moving
- painful urination
- problems with memory
- runny nose
- seeing, hearing, or feeling things that are not there
- sense of detachment from self or body
- shortness of breath
- sore throat
- sticking out of the tongue
- swollen joints
- tightness in the chest
- trouble in breathing, speaking, or swallowing
- 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
- Actions that are out of control
- attack, assault, or force
- chest pain
- continuing ringing or buzzing or other unexplained noise in 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
- lack of feeling or emotion
- loss of control of the legs
- loss of strength or energy
- numbness of the feet, hands, and around mouth
- severe sleepiness
- shakiness in the legs, arms, hands, or feet
- sleep talking
- talking, feeling, and acting with excitement
- thoughts of killing oneself
- unable to sleep
- unusual weak feeling
- voice changes
- General tiredness and weakness
- light-colored stools
- stomach pain, continuing
- upper right abdominal 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 mouth
- weight loss
- Abdominal 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
- double vision
- feeling of warmth
- heavy bleeding
- menstrual changes
- pelvic pain
- redness of the face, neck, arms, and occasionally, upper chest
- seeing double
- sudden sweating
- unexplained runny nose or sneezing
- Acid or sour stomach
- bigger, dilated, or enlarged pupils (black part of eye)
- change in color vision
- difficulty seeing at night
- feeling of constant movement of self or surroundings
- feeling of relaxation
- hives or welts
- increased sensitivity of eyes to sunlight
- redness of skin
- runny nose
- sensation of spinning
- stomach discomfort, upset, or pain
- stuffy nose
- 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 breasts
For Healthcare Professionals
Applies to alprazolam: compounding powder, oral concentrate, oral solution, oral tablet, oral tablet disintegrating, oral tablet extended release
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.
In addition, some investigators have reported the following effects as manifestations of alprazolam (the active ingredient contained in Alprazolam Intensol) 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 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 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 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 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 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.
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 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 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.
A short study on 58 patients with poor glycemic control concluded alprazolam (the active ingredient contained in Alprazolam Intensol) improved glucose regulation and the effect was not directly related to changes in anxiety.
Endocrine side effects have included improved glucose regulation.
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 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%).
More about Alprazolam Intensol (alprazolam)
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