Niravam
- Generic Name: alprazolam
- Brand Name: Niravam
Niravam (Alprazolam) side effects drug center
Niravam Side Effects Center
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.
Niravam Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Alprazolam can slow or stop your breathing, especially if you have recently used an opioid medication or alcohol. A person caring for you should give seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up.
Call your doctor at once if you have:
- weak or shallow breathing;
- a light-headed feeling, like you might pass out;
- a seizure;
- hallucinations, risk-taking behavior;
- increased energy, decreased need for sleep;
- racing thoughts, being agitated or talkative;
- double vision; or
- jaundice (yellowing of the skin or eyes).
Drowsiness or dizziness may last longer in older adults. Use caution to avoid falling or accidental injury.
Common side effects may include:
- drowsiness; or
- feeling light-headed.
After you stop using alprazolam, get medical help right away if you have symptoms such as: unusual muscle movements, being more active or talkative, sudden and severe changes in mood or behavior, confusion, hallucinations, seizures, suicidal thoughts or actions.
Some withdrawal symptoms may last up to 12 months or longer after stopping this medicine suddenly. Tell your doctor if you have ongoing anxiety, depression, problems with memory or thinking, trouble sleeping, ringing in your ears, a burning or prickly feeling, or a crawling sensation under your skin.
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)
&Copy; 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.