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Fioricet Adverse Events Reported to the FDA Over Time

How are Fioricet adverse event reports trending over time?

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

Most Common Fioricet Adverse Events Reported to the FDA

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

Completed Suicide
446 (2.16%)
Death
333 (1.62%)
Vomiting
321 (1.56%)
Overdose
309 (1.5%)
Drug Hypersensitivity
308 (1.49%)
Drug Toxicity
261 (1.27%)
Nausea
236 (1.15%)
Drug Interaction
235 (1.14%)
Dyspnoea
194 (.94%)
Somnolence
185 (.9%)
Malaise
181 (.88%)
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Multiple Drug Overdose
175 (.85%)
Headache
173 (.84%)
Drug Ineffective
167 (.81%)
Cardiac Arrest
164 (.8%)
Dizziness
155 (.75%)
Loss Of Consciousness
153 (.74%)
Abdominal Pain
150 (.73%)
Respiratory Arrest
149 (.72%)
Confusional State
145 (.7%)
Pyrexia
143 (.69%)
Multiple Drug Overdose Intentional
137 (.66%)
Constipation
136 (.66%)
Drug Abuse
136 (.66%)
Cardio-respiratory Arrest
134 (.65%)
Pain
134 (.65%)
Back Pain
124 (.6%)
Hypotension
118 (.57%)
Drug Exposure During Pregnancy
109 (.53%)
Suicide Attempt
108 (.52%)
Depression
105 (.51%)
Fatigue
103 (.5%)
Hallucination
103 (.5%)
Intentional Overdose
103 (.5%)
Diarrhoea
101 (.49%)
Intentional Drug Misuse
99 (.48%)
Alanine Aminotransferase Increased
96 (.47%)
Asthenia
94 (.46%)
Serotonin Syndrome
92 (.45%)
Pruritus
90 (.44%)
Fall
87 (.42%)
Respiratory Depression
86 (.42%)
Cough
85 (.41%)
Convulsion
84 (.41%)
Feeling Abnormal
82 (.4%)
Rash
81 (.39%)
Medication Error
79 (.38%)
Hyperhidrosis
77 (.37%)
Metabolic Acidosis
76 (.37%)
Hypertension
75 (.36%)
Poisoning
75 (.36%)
Weight Increased
75 (.36%)
Accidental Overdose
73 (.35%)
Dehydration
73 (.35%)
Hypersensitivity
73 (.35%)
Insomnia
73 (.35%)
Agitation
72 (.35%)
Drug Dependence
72 (.35%)
Depressed Level Of Consciousness
69 (.33%)
Tremor
69 (.33%)
Coma
68 (.33%)
Abdominal Pain Upper
66 (.32%)
Renal Failure Acute
64 (.31%)
Tachycardia
64 (.31%)
Pulmonary Oedema
63 (.31%)
Renal Failure
63 (.31%)
Aspartate Aminotransferase Increase...
60 (.29%)
Heart Rate Increased
60 (.29%)
Anxiety
58 (.28%)
Lethargy
58 (.28%)
Atrial Fibrillation
57 (.28%)
Pneumonia
57 (.28%)
Arthralgia
55 (.27%)
Oedema Peripheral
55 (.27%)
Unresponsive To Stimuli
54 (.26%)
Weight Decreased
54 (.26%)
Blood Creatinine Increased
53 (.26%)
Cerebrovascular Accident
53 (.26%)
Chest Pain
52 (.25%)
Condition Aggravated
52 (.25%)
Decreased Appetite
52 (.25%)
Urticaria
51 (.25%)
Pain In Extremity
50 (.24%)
Abdominal Distension
49 (.24%)
Blood Pressure Increased
49 (.24%)
International Normalised Ratio Incr...
49 (.24%)
Substance Abuse
49 (.24%)
Suicidal Ideation
49 (.24%)
Drug Abuser
48 (.23%)
Hypoxia
48 (.23%)
Jaundice
48 (.23%)
Muscle Spasms
48 (.23%)
Syncope
48 (.23%)
Migraine
47 (.23%)
Pancreatitis Acute
47 (.23%)
Musculoskeletal Stiffness
46 (.22%)
Myalgia
46 (.22%)
Amnesia
45 (.22%)
Delirium
45 (.22%)
Hepatic Failure
45 (.22%)
Hypoaesthesia
45 (.22%)

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

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

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

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

Pain
2117
Drug Use For Unknown Indication
1861
Product Used For Unknown Indication
1292
Cough
674
Migraine
595
Headache
464
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Back Pain
420
Rheumatoid Arthritis
192
Arthralgia
192
Analgesic Therapy
169
Osteoarthritis
123
Diarrhoea
112
Arthritis
102
Musculoskeletal Pain
72
Abdominal Pain
64
Ill-defined Disorder
64
Pain In Extremity
60
Bronchitis
56
Procedural Pain
54
Neck Pain
53
Fibromyalgia
52
Cancer Pain
48
Analgesia
47
Muscle Spasms
42
Drug Exposure During Pregnancy
42
Suicide Attempt
41
Sciatica
40
Toothache
38
Pain Management
35
Crohns Disease
34
Analgesic Effect
33
Upper Respiratory Tract Infection
33
Bone Pain
32
Breakthrough Pain
30
Tension Headache
28
Chest Pain
28
Antitussive Therapy
28
Neuralgia
27
Foetal Exposure During Pregnancy
27
Nasopharyngitis
25
Symphysiolysis
24
Pharyngitis Streptococcal
23
Pyrexia
23
Pneumonia
19
Postoperative Analgesia
19
Ankylosing Spondylitis
18
Post Herpetic Neuralgia
18
Bronchitis Chronic
18
Prophylaxis
17
Insomnia
17
Intentional Overdose
17

Drug Labels

LabelLabelerEffective
FioricetCardinal Health07-DEC-10
Fioricet With CodeineWatson Pharma, Inc.22-SEP-11
FioricetWatson Pharma, Inc.22-SEP-11

Fioricet Case Reports

What Fioricet 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 Fioricet. 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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