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Vicodin Adverse Events Reported to the FDA Over Time

How are Vicodin adverse event reports trending over time?

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

Most Common Vicodin Adverse Events Reported to the FDA

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

Completed Suicide
3203 (9.51%)
Cardiac Arrest
1159 (3.44%)
Respiratory Arrest
1112 (3.3%)
Cardio-respiratory Arrest
1111 (3.3%)
Intentional Drug Misuse
691 (2.05%)
Drug Ineffective
609 (1.81%)
Drug Abuse
594 (1.76%)
Death
570 (1.69%)
Nausea
523 (1.55%)
Drug Toxicity
494 (1.47%)
Vomiting
458 (1.36%)
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Multiple Drug Overdose
434 (1.29%)
Overdose
355 (1.05%)
Pain
324 (.96%)
Poisoning
301 (.89%)
Somnolence
289 (.86%)
Constipation
266 (.79%)
Dizziness
248 (.74%)
Confusional State
239 (.71%)
Multiple Drug Overdose Intentional
234 (.69%)
Fall
232 (.69%)
Headache
231 (.69%)
Depression
185 (.55%)
Loss Of Consciousness
177 (.53%)
Pruritus
175 (.52%)
Medication Error
173 (.51%)
Malaise
172 (.51%)
Feeling Abnormal
171 (.51%)
Hypotension
165 (.49%)
Anxiety
164 (.49%)
Dyspnoea
162 (.48%)
Drug Dependence
159 (.47%)
Insomnia
158 (.47%)
Mental Status Changes
155 (.46%)
Drug Interaction
147 (.44%)
Abdominal Pain
143 (.42%)
Convulsion
142 (.42%)
Intentional Overdose
137 (.41%)
Rash
135 (.4%)
Fatigue
133 (.39%)
Asthenia
130 (.39%)
Coma
127 (.38%)
Diarrhoea
126 (.37%)
Hallucination
125 (.37%)
Drug Abuser
124 (.37%)
Drug Hypersensitivity
123 (.37%)
Unresponsive To Stimuli
121 (.36%)
Agitation
115 (.34%)
Drug Screen Positive
114 (.34%)
Suicidal Ideation
114 (.34%)
Abdominal Pain Upper
113 (.34%)
Lethargy
109 (.32%)
Aspartate Aminotransferase Increase...
108 (.32%)
Back Pain
108 (.32%)
Hyperhidrosis
107 (.32%)
Alanine Aminotransferase Increased
100 (.3%)
Hypertension
99 (.29%)
Amnesia
98 (.29%)
Drug Effect Decreased
96 (.28%)
Memory Impairment
95 (.28%)
Heart Rate Increased
94 (.28%)
Pain In Extremity
94 (.28%)
Pulmonary Oedema
94 (.28%)
Depressed Level Of Consciousness
93 (.28%)
Accidental Overdose
91 (.27%)
Tremor
91 (.27%)
Chest Pain
90 (.27%)
Incorrect Dose Administered
89 (.26%)
Hypersensitivity
88 (.26%)
Weight Decreased
87 (.26%)
Arthralgia
86 (.26%)
Suicide Attempt
84 (.25%)
Pneumonia
81 (.24%)
Abdominal Discomfort
79 (.23%)
Blood Glucose Increased
77 (.23%)
Gait Disturbance
77 (.23%)
Drug Withdrawal Syndrome
73 (.22%)
Product Substitution Issue
73 (.22%)
Disorientation
72 (.21%)
Urticaria
72 (.21%)
Dehydration
71 (.21%)
Decreased Appetite
70 (.21%)
Oedema Peripheral
68 (.2%)
Condition Aggravated
65 (.19%)
Pulmonary Congestion
65 (.19%)
Muscle Spasms
64 (.19%)
Product Quality Issue
64 (.19%)
Respiratory Depression
64 (.19%)
Nervousness
63 (.19%)
Pyrexia
63 (.19%)
Blood Pressure Decreased
62 (.18%)
Multiple Drug Overdose Accidental
62 (.18%)
Road Traffic Accident
62 (.18%)
Hypoaesthesia
60 (.18%)
Vision Blurred
60 (.18%)
Weight Increased
60 (.18%)
Accidental Death
59 (.18%)
Aggression
59 (.18%)
Wrong Technique In Drug Usage Proce...
59 (.18%)
Abnormal Behaviour
57 (.17%)
Sedation
57 (.17%)

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

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

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

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

Pain
7881
Drug Use For Unknown Indication
3434
Product Used For Unknown Indication
3124
Back Pain
1257
Arthralgia
489
Breakthrough Pain
446
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Arthritis
256
Pain In Extremity
245
Fibromyalgia
211
Rheumatoid Arthritis
210
Headache
184
Migraine
175
Analgesic Therapy
159
Pain Management
143
Ill-defined Disorder
139
Procedural Pain
136
Osteoarthritis
128
Neck Pain
127
Abdominal Pain
119
Musculoskeletal Pain
113
Suicide Attempt
105
Back Disorder
85
Cough
61
Crohns Disease
53
Neuralgia
52
Bone Pain
51
Intervertebral Disc Protrusion
49
Analgesic Effect
46
Toothache
42
Herpes Zoster
42
Drug Abuse
40
Back Injury
40
Cancer Pain
39
Joint Injury
38
Postoperative Analgesia
37
Neuropathy Peripheral
36
Pain In Jaw
35
Muscle Spasms
35
Myalgia
35
Intervertebral Disc Degeneration
34
Sciatica
34
Completed Suicide
33
Surgery
27
Chest Pain
27
Insomnia
22
Dysmenorrhoea
21
Foetal Exposure During Pregnancy
20
Ankylosing Spondylitis
19
Drug Abuser
19
Spinal Column Stenosis
18
Sleep Disorder
17

Drug Labels

LabelLabelerEffective
VicodinesApotheca, Inc.25-FEB-10
VicodinCardinal Health03-DEC-10
Vicodin EsCardinal Health26-APR-11
Vicodin HpCardinal Health26-APR-11
VicodinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC06-JUN-12
Vicodin HpAbbott Laboratories12-SEP-12
Vicodin EsAbbott Laboratories12-SEP-12
VicodinAbbott Laboratories12-SEP-12

Vicodin Case Reports

What Vicodin 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 Vicodin. 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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