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Xanax Adverse Events Reported to the FDA Over Time

How are Xanax adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Xanax, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Xanax is flagged as the suspect drug causing the adverse event.

Most Common Xanax Adverse Events Reported to the FDA

What are the most common Xanax adverse events reported to the FDA?

Anxiety
767 (2.33%)
Drug Ineffective
713 (2.17%)
Insomnia
567 (1.72%)
Depression
518 (1.58%)
Feeling Abnormal
453 (1.38%)
Somnolence
393 (1.2%)
Headache
364 (1.11%)
Suicide Attempt
357 (1.09%)
Panic Attack
347 (1.06%)
Nausea
319 (.97%)
Malaise
315 (.96%)
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Fall
312 (.95%)
Convulsion
294 (.89%)
Drug Dependence
291 (.88%)
Suicidal Ideation
281 (.85%)
Dizziness
272 (.83%)
Tremor
272 (.83%)
Pain
270 (.82%)
Overdose
264 (.8%)
Fatigue
255 (.78%)
Loss Of Consciousness
245 (.75%)
Nervousness
239 (.73%)
Dyspnoea
234 (.71%)
Hypertension
227 (.69%)
Weight Decreased
223 (.68%)
Agitation
216 (.66%)
Drug Withdrawal Syndrome
215 (.65%)
Vomiting
213 (.65%)
Withdrawal Syndrome
206 (.63%)
Intentional Overdose
205 (.62%)
Confusional State
199 (.61%)
Diarrhoea
195 (.59%)
Road Traffic Accident
188 (.57%)
Amnesia
181 (.55%)
Hallucination
173 (.53%)
Memory Impairment
170 (.52%)
Drug Interaction
169 (.51%)
Weight Increased
157 (.48%)
Drug Exposure During Pregnancy
156 (.47%)
Decreased Appetite
148 (.45%)
Palpitations
148 (.45%)
Drug Abuse
141 (.43%)
Hyperhidrosis
139 (.42%)
Aggression
133 (.4%)
Mental Disorder
130 (.4%)
Blood Pressure Increased
123 (.37%)
Asthenia
122 (.37%)
Condition Aggravated
118 (.36%)
Crying
116 (.35%)
Disturbance In Attention
116 (.35%)
Abnormal Behaviour
114 (.35%)
Muscle Spasms
111 (.34%)
Multiple Drug Overdose Intentional
109 (.33%)
Abdominal Pain
108 (.33%)
Coma
107 (.33%)
Completed Suicide
107 (.33%)
Dry Mouth
107 (.33%)
Incorrect Dose Administered
105 (.32%)
Balance Disorder
104 (.32%)
Drug Toxicity
104 (.32%)
Gait Disturbance
104 (.32%)
Drug Effect Decreased
102 (.31%)
Heart Rate Increased
101 (.31%)
Oedema Peripheral
101 (.31%)
Blood Cholesterol Increased
100 (.3%)
Hypoaesthesia
100 (.3%)
Myocardial Infarction
100 (.3%)
Stress
100 (.3%)
Anger
99 (.3%)
Pruritus
99 (.3%)
Activities Of Daily Living Impaired
97 (.29%)
Chest Pain
97 (.29%)
Death
97 (.29%)
Pyrexia
96 (.29%)
Hypotension
95 (.29%)
Multiple Drug Overdose
93 (.28%)
Paraesthesia
92 (.28%)
Nightmare
88 (.27%)
Back Pain
87 (.26%)
Intentional Drug Misuse
87 (.26%)
Constipation
84 (.26%)
Pain In Extremity
82 (.25%)
Panic Reaction
82 (.25%)
Dysarthria
81 (.25%)
Thinking Abnormal
81 (.25%)
Abnormal Dreams
80 (.24%)
Sedation
80 (.24%)
Dehydration
79 (.24%)
Arthralgia
76 (.23%)
Disorientation
75 (.23%)
Paranoia
74 (.23%)
Vision Blurred
74 (.23%)
Sleep Disorder
72 (.22%)
Drug Hypersensitivity
71 (.22%)
Restlessness
71 (.22%)
Dyskinesia
69 (.21%)
Hypersensitivity
69 (.21%)
Abdominal Pain Upper
68 (.21%)
Burning Sensation
68 (.21%)
Drug Abuser
67 (.2%)
Medication Error
67 (.2%)

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This graph shows the top adverse events submitted to the FDA for Xanax, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Xanax is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Xanax

What are the most common Xanax adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Xanax, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Xanax is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Xanax According to Those Reporting Adverse Events

Why are people taking Xanax, according to those reporting adverse events to the FDA?

Anxiety
6442
Product Used For Unknown Indication
1274
Drug Use For Unknown Indication
1219
Depression
967
Panic Attack
688
Sleep Disorder
504
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Insomnia
460
Nervousness
271
Panic Disorder
250
Ill-defined Disorder
235
Stress
161
Anxiety Disorder
153
Bipolar Disorder
121
Post-traumatic Stress Disorder
79
Generalised Anxiety Disorder
69
Pain
67
Nervous System Disorder
61
Sleep Disorder Therapy
49
Agitation
46
Tremor
44
Mental Disorder
44
Premedication
40
Hypertension
39
Drug Abuse
34
Agoraphobia
34
Muscle Spasms
30
Neuropathy Peripheral
30
Back Pain
28
Drug Abuser
28
Anxiolytic Therapy
26
Psychotic Disorder
20
Restlessness
19
Prophylaxis
18
Schizophrenia
18
Suicide Attempt
18
Irritable Bowel Syndrome
18
Bipolar I Disorder
17
Intentional Overdose
16
Fibromyalgia
16
Muscle Relaxant Therapy
16
Relaxation Therapy
16
Sedative Therapy
15
Convulsion
15
Affective Disorder
14
Feeling Of Relaxation
14
Sedation
14
Obsessive-compulsive Disorder
14
Antidepressant Therapy
13
Panic Reaction
13
Mood Swings
13
Chest Pain
12

Drug Labels

LabelLabelerEffective
XanaxPhysicians Total Care, Inc.26-APR-10
XanaxPharmacia and Upjohn Company25-MAR-13
Xanax XrPharmacia and Upjohn Company26-MAR-13

Xanax Case Reports

What Xanax safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Xanax. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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