Niravam Side Effects

Generic Name: alprazolam

Please note - some side effects for Niravam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Niravam - for the Consumer

Niravam Orally Disintegrating Tablets

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 Niravam Orally Disintegrating Tablets:

Changes in appetite; constipation; decreased sexual desire or ability; diarrhea; dizziness; drowsiness; dry mouth; light-headedness; nausea; tiredness; weight changes.

Seek medical attention right away if any of these SEVERE side effects occur when using Niravam Orally Disintegrating Tablets:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); behavior changes; blurred vision; burning, numbness, or tingling; chest pain; confusion; dark urine; decreased coordination; decreased urination; fainting; fast or irregular heartbeat; hallucinations; loss of balance or muscle control; memory or attention problems; menstrual changes; muscle twitching; new or worsening mental or mood changes (eg, depression, irritability, anxiety; exaggerated feeling of well-being); overstimulation; red, swollen blistered, or peeling skin; severe or persistent dizziness, drowsiness, or light-headedness; shortness of breath or trouble breathing; suicidal thoughts or actions; tremor; trouble speaking; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Niravam Side Effects - for the Professional

Niravam

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)

a) Events reported by 1% or more of alprazolam patients are included.
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

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)

a) Events reported by 1% or more of alprazolam patients are included.
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

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, (5.1)].

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of Niravam. 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.

Top

Side Effects by Body System - for Healthcare Professionals

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 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.

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 (less than 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.

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

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%).

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.