Alprazolam Intensol Side Effects

Please note - some side effects for 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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Alprazolam Intensol - for the Consumer

Alprazolam Intensol Solution

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 Alprazolam Intensol Solution:

Changes in appetite; changes in sexual desire; constipation; dizziness; drowsiness; dry mouth; increased saliva production; lightheadedness; tiredness; trouble concentrating; unsteadiness; weight changes.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; decreased urination; fainting; hallucinations; loss of coordination; memory problems; menstrual changes; muscle twitching; new or worsening mental or mood problems (eg, depression, irritability, anxiety); overstimulation; red, swollen blistered, or peeling skin; seizures; severe dizziness; severe or persistent trouble sleeping; suicidal thoughts or actions; trouble speaking (eg, stammering, stuttering); yellowing of the eyes or skin.

Side Effects by Body System

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 year-long 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 (<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.

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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