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AMBIEN CR

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Ambien Cr Adverse Events Reported to the FDA Over Time

How are Ambien Cr adverse event reports trending over time?

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

Most Common Ambien Cr Adverse Events Reported to the FDA

What are the most common Ambien Cr adverse events reported to the FDA?

Amnesia
304 (6.67%)
Somnambulism
215 (4.72%)
Road Traffic Accident
171 (3.75%)
Fall
118 (2.59%)
Impaired Driving Ability
111 (2.44%)
Drug Ineffective
102 (2.24%)
Abnormal Behaviour
69 (1.51%)
Loss Of Consciousness
62 (1.36%)
Contusion
58 (1.27%)
Somnolence
58 (1.27%)
Confusional State
53 (1.16%)
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Hallucination
52 (1.14%)
Abnormal Sleep-related Event
46 (1.01%)
Pain
45 (.99%)
Concussion
39 (.86%)
Fatigue
39 (.86%)
Suicidal Ideation
39 (.86%)
Headache
38 (.83%)
Dizziness
37 (.81%)
Aggression
35 (.77%)
Feeling Abnormal
35 (.77%)
Nausea
35 (.77%)
Drug Abuse
34 (.75%)
Insomnia
34 (.75%)
Gait Disturbance
32 (.7%)
Depression
31 (.68%)
Wrong Technique In Drug Usage Proce...
31 (.68%)
Back Pain
28 (.61%)
Head Injury
28 (.61%)
Drug Interaction
27 (.59%)
Sleep Talking
27 (.59%)
Dyspnoea
26 (.57%)
Sleep-related Eating Disorder
26 (.57%)
Drug Dependence
25 (.55%)
Neck Pain
25 (.55%)
Anxiety
24 (.53%)
Skin Laceration
24 (.53%)
Incorrect Dose Administered
22 (.48%)
Pain In Extremity
22 (.48%)
Syncope
22 (.48%)
Agitation
21 (.46%)
Convulsion
20 (.44%)
Vomiting
20 (.44%)
Overdose
19 (.42%)
Condition Aggravated
18 (.4%)
Musculoskeletal Pain
18 (.4%)
Chest Pain
17 (.37%)
Hallucination, Visual
17 (.37%)
Haematoma
16 (.35%)
Hyperhidrosis
16 (.35%)
Memory Impairment
16 (.35%)
Nightmare
16 (.35%)
Panic Attack
16 (.35%)
Post-traumatic Amnestic Disorder
16 (.35%)
Transient Ischaemic Attack
16 (.35%)
Completed Suicide
15 (.33%)
Depressed Level Of Consciousness
15 (.33%)
Diarrhoea
15 (.33%)
Disorientation
15 (.33%)
Palpitations
15 (.33%)
Thinking Abnormal
15 (.33%)
Tremor
15 (.33%)
Altered State Of Consciousness
14 (.31%)
Psychotic Disorder
14 (.31%)
Rib Fracture
14 (.31%)
Skin Haemorrhage
14 (.31%)
Therapeutic Response Decreased
14 (.31%)
Drug Withdrawal Syndrome
13 (.29%)
Haemorrhage
13 (.29%)
Intentional Overdose
13 (.29%)
Laceration
13 (.29%)
Respiratory Arrest
13 (.29%)
Suicide Attempt
13 (.29%)
Urinary Retention
13 (.29%)
Alcohol Use
12 (.26%)
Disturbance In Attention
12 (.26%)
Intentional Drug Misuse
12 (.26%)
Malaise
12 (.26%)
Asthenia
11 (.24%)
Delirium
11 (.24%)
Hypoxia
11 (.24%)
Open Wound
11 (.24%)
Personality Change
11 (.24%)
Presyncope
11 (.24%)
Pupil Fixed
11 (.24%)
Weight Decreased
11 (.24%)
Abnormal Dreams
10 (.22%)
Delusion
10 (.22%)
Diplopia
10 (.22%)
Excoriation
10 (.22%)
Hypertension
10 (.22%)
Imprisonment
10 (.22%)
Spinal Fracture
10 (.22%)
Unresponsive To Stimuli
10 (.22%)
Abdominal Discomfort
9 (.2%)
Drug Effect Decreased
9 (.2%)
Drug Hypersensitivity
9 (.2%)
Dysarthria
9 (.2%)
Gastrooesophageal Reflux Disease
9 (.2%)
Gun Shot Wound
9 (.2%)
Heart Rate Increased
9 (.2%)

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This graph shows the top adverse events submitted to the FDA for Ambien Cr, 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 Ambien Cr 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 Ambien Cr

What are the most common Ambien Cr adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Ambien Cr, 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 Ambien Cr 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 Ambien Cr According to Those Reporting Adverse Events

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

Insomnia
641
Sleep Disorder
215
Drug Use For Unknown Indication
124
Product Used For Unknown Indication
49
Sleep Disorder Therapy
27
Sleep Apnoea Syndrome
9
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Somnolence
7
Initial Insomnia
7
Pain
6
Depression
6
Anxiety
5
Bipolar Disorder
5
Stress
4
Fibromyalgia
3
Multiple Sclerosis
3
Middle Insomnia
3
Unevaluable Event
2
Fatigue
2
Insomnia Related To Another Mental ...
2
Menopause
2
Sleep Study
2
Hypersomnia
1
Sleep Disorder Due To General Medic...
1
Hormone Replacement Therapy
1
Post Laminectomy Syndrome
1
Relaxation Therapy
1
Poor Quality Sleep
1
Arthritis
1
Post-traumatic Stress Disorder
1
Delayed Sleep Phase
1
Spondylolisthesis
1
Mental Status Changes
1
Sleep Walking
1
Suicide Attempt
1
Restless Legs Syndrome
1
Schizophrenia, Paranoid Type
1
Circadian Rhythm Sleep Disorder
1
Post Concussion Syndrome
1
Pain Management
1
Death Of Relative
1
Anxiety Disorder
1
Surgery
1
Bipolar Ii Disorder
1
Spinal Disorder
1
Restlessness
1

Drug Labels

LabelLabelerEffective
Ambien CrBryant Ranch Prepack30-JUN-09
Ambien CrBryant Ranch Prepack30-JUN-09
Ambien CrRebel Distributors Corp.01-OCT-09
Ambien CrPD-Rx Pharmaceuticals, Inc.13-OCT-10
Ambien CrLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-NOV-11
Ambien CrLake Erie Medical & Surgical Supply DBA Quality Care Products LLC13-DEC-11
Ambien CrSTAT Rx USA LLC30-APR-12
Ambien Crsanofi-aventis U.S. LLC11-MAY-12
Ambien Cr St Marys Medical Park Pharmacy10-AUG-12
Ambien CrPhysicians Total Care, Inc.04-SEP-12
Ambien Crsanofi-aventis U.S. LLC30-APR-13

Ambien Cr Case Reports

What Ambien Cr 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 Ambien Cr. 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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