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Niravam

Last reviewed on RxList: 12/29/2016
Niravam Side Effects Center

Last reviewed on RxList 1/7/2016

Niravam (alprazolam) is a benzodiazepine used to treat anxiety disorders, panic disorders, and anxiety caused by depression. Niravam is available in generic form. Common side effects of Niravam include drowsiness, dizziness, tiredness, irritability, increased saliva production, changes in sex drive/ability, blurred vision, headache, memory problems, trouble concentrating, sleep problems (insomnia), swelling in your hands or feet, muscle weakness, lack of balance or coordination, slurred speech, upset stomach, nausea, vomiting, constipation, diarrhea, increased sweating, dry mouth, stuffy nose, appetite or weight changes.

To treat generalized anxiety disorder, the adult starting dose of of Niravam is 0.25 mg to 0.5 mg three times daily. The dose may be increased at intervals of 3 to 4 days, to a maximum daily dose of 4 mg, given in divided doses. Niravam may interact with other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety), birth control pills, cimetidine, diltiazem, isoniazid, propoxyphene, seizure medications, antifungals, or antidepressants. Tell your doctor all medications you use. Niravam is not recommended for use during pregnancy due to the potential for harm to a fetus. This drug passes into breast milk and may have undesirable effects on a nursing infant. Breastfeeding while using this drug is not recommended. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Niravam (alprazolam) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Niravam Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • depressed mood, thoughts of suicide or hurting yourself, unusual risk-taking behavior, decreased inhibitions, no fear of danger;
  • confusion, hyperactivity, agitation, hostility, hallucinations;
  • feeling like you might pass out;
  • urinating less than usual or not at all;
  • chest pain, pounding heartbeats or fluttering in your chest;
  • uncontrolled muscle movements, tremor, seizure (convulsions); or
  • jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • drowsiness, dizziness, feeling tired or irritable;
  • blurred vision, headache, memory problems, trouble concentrating;
  • sleep problems (insomnia);
  • swelling in your hands or feet;
  • muscle weakness, lack of balance or coordination, slurred speech;
  • upset stomach, nausea, vomiting, constipation, diarrhea;
  • increased sweating, dry mouth, stuffy nose; or
  • appetite or weight changes, loss of interest in sex.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Niravam (Alprazolam)

Niravam Professional Information

SIDE EFFECTS

Clinical Trial Experience

The most commonly reported ( ≥ 5% and ~ twice the rate of placebo) adverse reactions with NIRAVAM treatment are: sedation, impaired coordination, dysarthria, and increased libido.

The data cited in the two tables below are estimates of adverse reactions occurring in patients who participated in clinical trials under the following conditions: relatively short duration (four weeks) placebo-controlled clinical studies with dosages up to 4 mg per day of (for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety) and short-term (up to ten weeks) placebo-controlled clinical studies with dosages up to 10 mg per day of in patients with panic disorder, with or without agoraphobia.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Comparison of the cited figures, however, can provide the prescriber with some basis for estimating the relative contributions of drug and non-drug factors to the adverse reaction incidence in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient but induce it in others. (For example, an anxiolytic drug may relieve dry mouth [a symptom of anxiety] in some subjects but induce dry mouth in others.)

Table 1: Adverse Reactions Reported in Placebo-Controlled Trials of Alprazolam in Generalized Anxiety Disorder ( > 2% and at a rate greater than placebo)

GENERALIZED ANXIETY DISORDER
Body System/Adverse Reaction Treatment-Emergent Symptom Incidencea
ALPRAZOLAM (%)
N = 565
PLACEBO (%)
N = 505
Central Nervous System
  Sedation 41 22
  Lightheadedness 21 19
  Dizziness 2 1
  Akathisia 2 1
Gastrointestinal
  Dry Mouth 15 13
  Increased Salivation 4 2
Cardiovascular
  Hypotension 5 2
Cutaneous
  Dermatitis/Allergy 4 3
a) Events reported by 1% or more of alprazolam patients are included.
b) None reported

In addition to the relatively common (i.e., greater than 1%) adverse reactions described in the table above, the following adverse reactions have been reported in association with the use of benzodiazepines: dystonia, irritability, concentration difficulties, anorexia, transient amnesia or memory impairment, loss of coordination, fatigue, seizures, sedation, slurred speech, jaundice, musculoskeletal weakness, pruritus, diplopia, dysarthria, changes in libido, menstrual irregularities, incontinence and urinary retention.

Table 2: Adverse Reactions Reported in Placebo-Controlled Trials of Alprazolam in Panic Disorder ( > 2% and greater than placebo)

PANIC DISORDER
Body System/Adverse Reaction Treatment-Emergent Symptom Incidencea
ALPRAZOLAM (%)
N = 1388
PLACEBO (%)
N = 1231
Central Nervous System
  Sedation 77 43
  Fatigue and Tiredness 49 42
  Impaired Coordination 40 18
  Irritability 33 30
  Memory Impairment 33 22
  Cognitive Disorder 29 21
  Dysarthria 23 6
  Decreased Libido 14 8
  Confusional State 10 8
  Increased Libido 8 4
  Change in Libido (Not Specified) 7 6
  Disinhibition 3 2
  Talkativeness 2 1
  Derealization 2 1
Gastrointestinal
  Constipation 26 15
  Increased Salivation 6 4
Cutaneous
  Rash 11 8
Other
  Increased Appetite 33 23
  Decreased Appetite 28 24
  Weight Gain 27 18
  Weight Loss 23 17
  Micturition Difficulties 12 9
  Menstrual Disorders 10 9
  Sexual Dysfunction 7 4
  Incontinence 2 1
a) Events reported by 1% or more of alprazolam patients are included.

In addition to the relatively common (i.e., greater than 1%) adverse reactions described in the table above, the following adverse reactions have been reported in association with the use of alprazolam: seizures, hallucinations, depersonalization, taste alterations, diplopia, elevated bilirubin, elevated hepatic enzymes, and jaundice.

Panic disorder has been associated with primary and secondary major depressive disorders and increased reports of suicide among untreated patients [see WARNINGS AND PRECAUTIONS].

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of NIVARAM. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Reported events include: liver enzyme elevations, hepatitis, hepatic failure, Stevens-Johnson syndrome, hyperprolactinemia, gynecomastia, and galactorrhea.

Read the entire FDA prescribing information for Niravam (Alprazolam)

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© Niravam Patient Information is supplied by Cerner Multum, Inc. and Niravam Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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