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Niravam Side Effects

Generic name: alprazolam

Medically reviewed by Drugs.com. Last updated on Sep 26, 2022.

Note: This document contains side effect information about alprazolam. Some dosage forms listed on this page may not apply to the brand name Niravam.

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

Serious side effects of Niravam

Along with its needed effects, alprazolam (the active ingredient contained in Niravam) 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

Less common

Rare

Incidence not known

Other side effects of Niravam

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

Less common

Rare

Incidence not known

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.[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

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[Ref]

Immunologic

Immediate-release formulations:

Common (1% to 10%): Infection

Extended-release tablets:

Common (1% to 10%): Influenza[Ref]

Hypersensitivity

Immediate-release formulations:

Common (1% to 10%): Allergy

Postmarketing reports: Angioedema

Extended-release tablets:

Postmarketing reports: Angioedema[Ref]

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[Ref]

Endocrine

Immediate-release formulations:

Postmarketing reports: Gynecomastia, hyperprolactinemia

Extended-release tablets:

Postmarketing reports: Gynecomastia, hyperprolactinemia[Ref]

Frequently asked questions

References

1. Product Information. Xanax (alprazolam). Pharmacia and Upjohn. 2002;PROD.

2. Product Information. Niravam (alprazolam). Schwarz Pharma. 2005.

3. Product Information. Xanax XR (alprazolam). Pfizer U.S. Pharmaceuticals Group. 2005.

4. Cerner Multum, Inc. UK Summary of Product Characteristics.

5. Cerner Multum, Inc. Australian Product Information.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.