ADVERSE REACTIONS (See also PRECAUTIONS)
Commonly Observed
The more commonly observed untoward events associated with the use of BuSpar not seen at an equivalent incidence among placebo-treated patients include dizziness, nausea, headache, nervousness, lightheadedness, and excitement.
Associated with Discontinuation of Treatment
One guide to the relative clinical importance of adverse events associated with BuSpar is provided by the frequency with which they caused drug discontinuation during clinical testing. Approximately 10% of the 2200 anxious patients who participated in the BuSpar premarketing clinical efficacy trials in anxiety disorders lasting 3 to 4 weeks discontinued treatment due to an adverse event. The more common events causing discontinuation included: central nervous system disturbances (3.4%), primarily dizziness, insomnia, nervousness, drowsiness, and lightheaded feeling; gastrointestinal disturbances (1.2%), primarily nausea; and miscellaneous disturbances (1.1%), primarily headache and fatigue. In addition, 3.4% of patients had multiple complaints, none of which could be characterized as primary.
Incidence in Controlled Clinical Trials
The table that follows enumerates adverse events that occurred at a frequency of 1% or more among BuSpar (buspirone hydrochloride) patients who participated in 4-week, controlled trials comparing BuSpar with placebo. The frequencies were obtained from pooled data for 17 trials. The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. Comparison of the cited figures, however, does provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.
TREATMENT-EMERGENT ADVERSE EXPERIENCE INCIDENCE IN PLACEBO-CONTROLLED CLINICAL TRIALS* | (Percent of Patients Reporting) |
|---|
| Adverse Experience | BuSpar
(n=477) | Placebo
(n=464) |
|---|
| * Events reported by at least 1% of BuSpar patients are included. |
| — Incidence less than 1%. |
| Cardiovascular | | |
| Tachycardia/Palpitations | 1 | 1 |
| CNS | | |
| Dizziness | 12 | 3 |
| Drowsiness | 10 | 9 |
| Nervousness | 5 | 1 |
| Insomnia | 3 | 3 |
| Lightheadedness | 3 | — |
| Decreased Concentration | 2 | 2 |
| Excitement | 2 | — |
| Anger/Hostility | 2 | — |
| Confusion | 2 | — |
| Depression | 2 | 2 |
| EENT | | |
| Blurred Vision | 2 | — |
| Gastrointestinal | | |
| Nausea | 8 | 5 |
| Dry Mouth | 3 | 4 |
| Abdominal/Gastric Distress | 2 | 2 |
| Diarrhea | 2 | — |
| Constipation | 1 | 2 |
| Vomiting | 1 | 2 |
| Musculoskeletal | | |
| Musculoskeletal Aches/Pains | 1 | — |
| Neurological | | |
| Numbness | 2 | — |
| Paresthesia | 1 | — |
| Incoordination | 1 | — |
| Tremor | 1 | — |
| Skin | | |
| Skin Rash | 1 | — |
| Miscellaneous | | |
| Headache | 6 | 3 |
| Fatigue | 4 | 4 |
| Weakness | 2 | — |
| Sweating/Clamminess | 1 | — |
Other Events Observed During the Entire Premarketing Evaluation of BuSpar
During its premarketing assessment, BuSpar was evaluated in over 3500 subjects. This section reports event frequencies for adverse events occurring in approximately 3000 subjects from this group who took multiple doses of BuSpar in the dose range for which BuSpar is being recommended (ie, the modal daily dose of BuSpar fell between 10 mg and 30 mg for 70% of the patients studied) and for whom safety data were systematically collected. The conditions and duration of exposure to BuSpar varied greatly, involving well-controlled studies as well as experience in open and uncontrolled clinical settings. As part of the total experience gained in clinical studies, various adverse events were reported. In the absence of appropriate controls in some of the studies, a causal relationship to BuSpar (buspirone hydrochloride) treatment cannot be determined. The list includes all undesirable events reasonably associated with the use of the drug.
The following enumeration by organ system describes events in terms of their relative frequency of reporting in this data base. Events of major clinical importance are also described in the PRECAUTIONS section.
The following definitions of frequency are used: Frequent adverse events are defined as those occurring in at least 1/100 patients. Infrequent adverse events are those occurring in 1/100 to 1/1000 patients, while rare events are those occurring in less than 1/1000 patients.
Cardiovascular
Frequent was nonspecific chest pain; infrequent were syncope, hypotension, and hypertension; rare were cerebrovascular accident, congestive heart failure, myocardial infarction, cardiomyopathy, and bradycardia.
Central Nervous System
Frequent were dream disturbances; infrequent were depersonalization, dysphoria, noise intolerance, euphoria, akathisia, fearfulness, loss of interest, dissociative reaction, hallucinations, involuntary movements, slowed reaction time, suicidal ideation, and seizures; rare were feelings of claustrophobia, cold intolerance, stupor, and slurred speech and psychosis.
EENT
Frequent were tinnitus, sore throat, and nasal congestion; infrequent were redness and itching of the eyes, altered taste, altered smell, and conjunctivitis; rare were inner ear abnormality, eye pain, photophobia, and pressure on eyes.
Endocrine
Rare were galactorrhea and thyroid abnormality.
Gastrointestinal
Infrequent were flatulence, anorexia, increased appetite, salivation, irritable colon, and rectal bleeding; rare was burning of the tongue.
Genitourinary
Infrequent were urinary frequency, urinary hesitancy, menstrual irregularity and spotting, and dysuria; rare were amenorrhea, pelvic inflammatory disease, enuresis, and nocturia.
Musculoskeletal
Infrequent were muscle cramps, muscle spasms, rigid/stiff muscles, and arthralgias; rare was muscle weakness.
Respiratory
Infrequent were hyperventilation, shortness of breath, and chest congestion; rare was epistaxis.
Sexual Function
Infrequent were decreased or increased libido; rare were delayed ejaculation and impotence.
Skin
Infrequent were edema, pruritus, flushing, easy bruising, hair loss, dry skin, facial edema, and blisters; rare were acne and thinning of nails.
Clinical Laboratory
Infrequent were increases in hepatic aminotransferases (SGOT, SGPT); rare were eosinophilia, leukopenia, and thrombocytopenia.
Miscellaneous
Infrequent were weight gain, fever, roaring sensation in the head, weight loss, and malaise; rare were alcohol abuse, bleeding disturbance, loss of voice, and hiccoughs.
Postmarketing Experience
Postmarketing experience has shown an adverse experience profile similar to that given above. Voluntary reports since introduction have included rare occurrences of allergic reactions (including urticaria), angioedema, cogwheel rigidity, dizziness (rarely reported as vertigo), dystonic reactions (including dystonia), ataxias, extrapyramidal symptoms, dyskinesias (acute and tardive), ecchymosis, emotional lability, serotonin syndrome, transient difficulty with recall, urinary retention, visual changes (including tunnel vision), parkinsonism, akathisia, restless leg syndrome, and restlessness. Because of the uncontrolled nature of these spontaneous reports, a causal relationship to BuSpar treatment has not been determined.
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REPORTS OF SUSPECTED BUSPAR SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Buspar. The information is not vetted and should not be considered as verified clinical evidence.
Possible Buspar side effects / adverse reactions in 10 year old male
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: 10 year old male
Reactions: Epistaxis
Suspect drug(s):
Buspar
Possible Buspar side effects / adverse reactions in 38 year old male
Reported by a consumer/non-health professional from United States on 2011-10-26
Patient: 38 year old male
Reactions: Drug Ineffective
Suspect drug(s):
Buspar
Possible Buspar side effects / adverse reactions in 15 year old male
Reported by a individual with unspecified qualification from United States on 2011-11-14
Patient: 15 year old male
Reactions: Agitation, Breast Enlargement, Drug Ineffective, Pain, Adverse Drug Reaction, Rectal Haemorrhage, Deafness, Headache, Gastric Ulcer, Somnolence, Constipation, Suicidal Ideation, Weight Increased, Fatigue, Anger, Rapid Eye Movements Sleep Abnormal, Muscle Spasms, Hyperacusis, Condition Aggravated, Abnormal Behaviour, Rash, Aggression, Anxiety, Affective Disorder, Insomnia, Disturbance in Attention, Erection Increased, Memory Impairment, Feeling Abnormal, Influenza
Suspect drug(s):
Soma
Indication: Product Used FOR Unknown Indication
Tegretol
Indication: Product Used FOR Unknown Indication
Carbamazepine
Indication: Product Used FOR Unknown Indication
Imitrex
Indication: Product Used FOR Unknown Indication
Risperdal
Indication: Product Used FOR Unknown Indication
Seroquel
Indication: Product Used FOR Unknown Indication
Pamelor
Indication: Product Used FOR Unknown Indication
Mirtazapine
Indication: Product Used FOR Unknown Indication
Celebrex
Indication: Product Used FOR Unknown Indication
Geodon
Indication: Product Used FOR Unknown Indication
Lamictal
Indication: Product Used FOR Unknown Indication
Valium
Indication: Pain
Zomig
Indication: Product Used FOR Unknown Indication
Trazodone HCL
Indication: Depression
Lithium Carbonate
Indication: Product Used FOR Unknown Indication
Lexapro
Indication: Product Used FOR Unknown Indication
Metaxalone
Indication: Product Used FOR Unknown Indication
Wellbutrin
Indication: Product Used FOR Unknown Indication
Cymbalta
Indication: Depression
Klonopin
Indication: Product Used FOR Unknown Indication
Zoloft
Indication: Product Used FOR Unknown Indication
Effexor XR
Indication: Product Used FOR Unknown Indication
Buspar
Indication: Product Used FOR Unknown Indication
Paxil
Indication: Product Used FOR Unknown Indication
Effexor
Dosage: (3.75 mg)
Indication: Product Used FOR Unknown Indication
Depakote
Indication: Headache
Zyprexa
Indication: Product Used FOR Unknown Indication
Elavil
Indication: Product Used FOR Unknown Indication
Ritalin
Indication: Headache
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