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CAFFEINE

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Caffeine Adverse Events Reported to the FDA Over Time

How are Caffeine adverse event reports trending over time?

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

Most Common Caffeine Adverse Events Reported to the FDA

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

Completed Suicide
663 (2.59%)
Overdose
389 (1.52%)
Vomiting
383 (1.49%)
Drug Toxicity
347 (1.35%)
Drug Hypersensitivity
321 (1.25%)
Nausea
296 (1.15%)
Drug Interaction
262 (1.02%)
Somnolence
245 (.96%)
Headache
235 (.92%)
Drug Ineffective
220 (.86%)
Cardiac Arrest
216 (.84%)
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Dyspnoea
216 (.84%)
Malaise
216 (.84%)
Multiple Drug Overdose
212 (.83%)
Death
210 (.82%)
Dizziness
207 (.81%)
Respiratory Arrest
191 (.74%)
Loss Of Consciousness
183 (.71%)
Pyrexia
172 (.67%)
Abdominal Pain
165 (.64%)
Multiple Drug Overdose Intentional
161 (.63%)
Confusional State
155 (.6%)
Intentional Drug Misuse
153 (.6%)
Drug Abuse
147 (.57%)
Suicide Attempt
147 (.57%)
Constipation
146 (.57%)
Cardio-respiratory Arrest
143 (.56%)
Pain
142 (.55%)
Intentional Overdose
140 (.55%)
Back Pain
138 (.54%)
Drug Exposure During Pregnancy
133 (.52%)
Drug Dependence
132 (.51%)
Depression
131 (.51%)
Asthenia
129 (.5%)
Fatigue
129 (.5%)
Hypotension
128 (.5%)
Feeling Abnormal
125 (.49%)
Diarrhoea
123 (.48%)
Medication Error
117 (.46%)
Alanine Aminotransferase Increased
109 (.43%)
Hypertension
108 (.42%)
Hallucination
105 (.41%)
Hyperhidrosis
103 (.4%)
Pruritus
103 (.4%)
Convulsion
101 (.39%)
Poisoning
97 (.38%)
Serotonin Syndrome
97 (.38%)
Fall
94 (.37%)
Accidental Overdose
93 (.36%)
Cough
93 (.36%)
Hypersensitivity
93 (.36%)
Insomnia
93 (.36%)
Anxiety
91 (.35%)
Tachycardia
91 (.35%)
Agitation
90 (.35%)
Drug Abuser
90 (.35%)
Tremor
89 (.35%)
Respiratory Depression
88 (.34%)
Rash
87 (.34%)
Coma
85 (.33%)
Condition Aggravated
82 (.32%)
Weight Increased
82 (.32%)
Heart Rate Increased
81 (.32%)
Renal Failure
81 (.32%)
Abdominal Pain Upper
80 (.31%)
Dehydration
80 (.31%)
Depressed Level Of Consciousness
80 (.31%)
Metabolic Acidosis
78 (.3%)
Pulmonary Oedema
78 (.3%)
Aspartate Aminotransferase Increase...
75 (.29%)
Renal Failure Acute
73 (.28%)
Atrial Fibrillation
72 (.28%)
Unresponsive To Stimuli
72 (.28%)
Pneumonia
70 (.27%)
Drug Administration Error
68 (.27%)
Incorrect Dose Administered
65 (.25%)
Chest Pain
64 (.25%)
Arthralgia
63 (.25%)
Blood Pressure Increased
63 (.25%)
Lethargy
63 (.25%)
Decreased Appetite
62 (.24%)
Cerebrovascular Accident
61 (.24%)
Oedema Peripheral
60 (.23%)
Syncope
59 (.23%)
Migraine
58 (.23%)
Substance Abuse
58 (.23%)
Urticaria
58 (.23%)
Weight Decreased
58 (.23%)
Muscle Spasms
57 (.22%)
Blood Creatinine Increased
56 (.22%)
Suicidal Ideation
56 (.22%)
Pain In Extremity
55 (.21%)
Abdominal Distension
54 (.21%)
Myalgia
54 (.21%)
Hypoaesthesia
53 (.21%)
Hypokalaemia
53 (.21%)
International Normalised Ratio Incr...
53 (.21%)
Delirium
52 (.2%)
Tinnitus
52 (.2%)
Jaundice
51 (.2%)
Paraesthesia
51 (.2%)

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

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

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

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

Pain
2124
Drug Use For Unknown Indication
2068
Product Used For Unknown Indication
1450
Cough
676
Back Pain
433
Headache
394
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Migraine
350
Arthralgia
198
Rheumatoid Arthritis
192
Analgesic Therapy
173
Osteoarthritis
129
Diarrhoea
112
Arthritis
106
Ill-defined Disorder
106
Musculoskeletal Pain
74
Abdominal Pain
66
Suicide Attempt
65
Pain In Extremity
61
Bronchitis
59
Fibromyalgia
54
Procedural Pain
54
Nasopharyngitis
50
Sciatica
49
Cancer Pain
48
Neck Pain
48
Muscle Spasms
45
Analgesia
45
Drug Exposure During Pregnancy
45
Toothache
44
Analgesic Effect
37
Upper Respiratory Tract Infection
35
Pain Management
35
Foetal Exposure During Pregnancy
35
Crohns Disease
34
Bone Pain
32
Chest Pain
30
Neuralgia
28
Antitussive Therapy
28
Breakthrough Pain
27
Pyrexia
26
Insomnia
25
Symphysiolysis
24
Ankylosing Spondylitis
24
Pharyngitis
24
Pharyngitis Streptococcal
23
Influenza
22
Intentional Overdose
22
Upper Respiratory Tract Inflammatio...
20
Prophylaxis
20
Somnolence
19
Pneumonia
19

Drug Labels

LabelLabelerEffective
Butalbital, Aspirin And Caffeine TabletsQualitest17-AUG-09
Caffeine CitrateSun Pharmaceutical Industries Ltd02-OCT-09
FiorinalWatson Pharma, Inc.16-OCT-09
Ascomp With CodeineBreckenridge Pharmaceutical, Inc.16-OCT-09
Butalbital, Acetaminophen, Caffeine And Codeine PhosphateBreckenridge Pharmaceutical, Inc.20-OCT-09
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphatePhysicians Total Care, Inc.22-OCT-09
Excedrinmenstrual CompleteNovartis Consumer Health, Inc.28-OCT-09
Caffeine CitratePaddock Laboratories, Inc.20-NOV-09
Dihydrocodeine Bitartrate, Acetaminophen And CaffeinePhysicians Total Care, Inc.24-NOV-09
Butalbital, Acetaminophen, And CaffeineNexgen Pharma, Inc.07-DEC-09
Caffeine CitrateAPP Pharmaceuticals, LLC15-DEC-09
Caffeine CitrateAPP Pharmaceuticals, LLC15-DEC-09
Butalbital, Acetominophen And CaffeineRising Pharmaceuticals, Inc.18-DEC-09
Butalbital, Acetominophen And CaffeineRising Pharmaceuticals, Inc.18-DEC-09
Ascomp With CodeineNexgen Pharma, Inc.27-JAN-10
Caffeine CitrateSun Pharma Global FZE17-FEB-10
OrbivanAtley Pharmaceuticals, Inc.23-APR-10
Butalbital, Acetaminophen And CaffeinePhysicians Total Care, Inc.20-MAY-10
CafcitBedford Laboratories09-JUN-10
Butalbital, Aspirin And CaffeinePD-Rx Pharmaceuticals, Inc.11-JUN-10
Butalbital, Aspirin, And CaffeineWatson Laboratories, Inc.24-JUN-10
Fiorinal With CodeineWatson Pharma, Inc.25-JUN-10
Butalbital, Aspirin, Caffeine And Codeine PhosphateWatson Laboratories, Inc.25-JUN-10
Ergotamine Tartrate And CaffeineKAISER FOUNDATION HOSPITALS28-JUN-10
Butalbital, Acetaminophen And CaffeinePhysicians Total Care, Inc.29-JUN-10
Butalbital, Aspirin, Caffeine And Codeine PhosphatePhysicians Total Care, Inc.29-JUN-10
Butalbital, Acetaminophen And CaffeineKeltman Pharmaceuticals Inc.20-JUL-10
Butalbital, Aspirin, And CaffeineRebel Distributors Corp20-SEP-10
Butalbital, Acetaminophen And CaffeineRebel Distributors Corp.20-SEP-10
Butalbital, Acetaminophen, And CaffeineRebel Distributors Corp20-SEP-10
Butalbital, Aspirin, And CaffeineSTAT RX USA LLC22-SEP-10
Butalbital Acetaminophen And CaffeineLake Erie Medical DBA Quality Care Products LLC11-OCT-10
Orphenadrine Citrate, Aspirin And CaffeineRebel Distributors Corp22-OCT-10
Butalbital, Aspirin, And CaffeineLannett Company, Inc.03-NOV-10
FioricetCardinal Health07-DEC-10
Butalbital, Aspirin And CaffeineRebel Distributors Corp10-DEC-10
Acetaminophen, Butalbital And CaffeineSTAT RX USA LLC09-FEB-11
Caffeine Withdrawal Newton Laboratories, Inc.01-MAR-11
CafergotKAISER FOUNDATION HOSPITALS25-APR-11
Butalbital, Acetaminophen, And CaffeinePreferred Pharmaceuticals, Inc14-JUN-11
Butalbital, Acetaminophen And CaffeineCardinal Health17-JUN-11
Acetaminophen, Caffeine And Dihydrocodeine BitartrateBoca Pharmacal, Inc.22-JUN-11
Butalbital, Acetaminophen, And CaffeineWest-ward Pharmaceutical Corp30-JUN-11
Butalbital, Acetaminophen And CaffeineVictory Pharmaceutical01-JUL-11
Butalbital, Acetaminophen And Caffeine With Codeine PhosphateWest-ward Pharmaceutical Corp15-JUL-11
Butalbital, Acetaminophen And CaffeinePD-Rx Pharmaceuticals, Inc.28-JUL-11
Butalbital, Acetaminophen And CaffeineRebel Distributors Corp01-AUG-11
Butalbital, Acetaminophen And CaffeineMikart, Inc.01-AUG-11
Butalbital, Acetaminophen, And CaffeineMirror Pharmaceuticals LLC08-AUG-11
Butalbital, Acetaminophen, And CaffeineMirror Pharmaceuticals LLC08-AUG-11
Butalbital, Acetaminophen And CaffeineRedPharm Drug Inc.15-AUG-11
CaffeineWOONSOCKET PRESCRIPTION CENTER,INCORPORATED19-AUG-11
Isometheptene Mucate, Caffeine, And AcetaminophenWomens Choice Pharmaceuticals, LLC29-AUG-11
Butalbital, Acetaminophen And CaffeineH.J. Harkins Company, Inc.06-SEP-11
Caffeine And Sodium BenzoateAmerican Regent, Inc.06-SEP-11
FioricetWatson Pharma, Inc.22-SEP-11
Fioricet With CodeineWatson Pharma, Inc.22-SEP-11
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateWatson Laboratories, Inc.22-SEP-11
Butalbital, Acetaminophen, And CaffeineWatson Laboratories, Inc.22-SEP-11
Butalbital, Aspirin And CaffeineDispensing Solutions, Inc.29-SEP-11
Butalbital, Acetaminophen, Caffeine And Codeine PhosphateDispensing Solutions, Inc.03-OCT-11
Caffeine CitrateAmerican Regent, Inc.08-OCT-11
Orphenadrine Citrate, Aspirin And CaffeineEon Labs, Inc.21-OCT-11
ZebutalShionogi Inc.08-NOV-11
Butalbital, Acetaminophen, CaffeineREMEDYREPACK INC. 10-NOV-11
Butalbital Acetaminophen And CaffeineLake Erie Medical DBA Quality Care Products LLC01-DEC-11
Butalbital, Acetaminophen And CaffeineQualitest Pharmaceuticals12-DEC-11
Butalbital, Aspirin And CaffeinePhysicians Total Care, Inc.12-DEC-11
Butalbital, Aspirin And CaffeineH.J. Harkins Company03-JAN-12
Butalbital, Acetaminophen, And CaffeineGolden State Medical Supply, Inc.09-JAN-12
Medique Ccp Caffeine FreeUnifirst First Aid Corporation26-JAN-12
Butalbital, Aspirin And CaffeineWest-ward Pharmaceutical Corp26-JAN-12
Medique Ccp Caffeine FreeUnifirst First Aid Corporation26-JAN-12
Otis Clapp Emagrin ForteUnifirst First Aid Corporation26-JAN-12
Maximum Strength CaffeineWOONSOCKET PRESCRIPTION CENTER,INCORPORATED21-FEB-12
Butalbital, Aspirin And CaffeineLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-FEB-12
Butalbital, Acetaminophen And CaffeineQualitest Pharmaceuticals01-MAR-12
Butalbital, Acetaminophen, And CaffeineSTAT Rx USA LLC29-MAR-12
Butalbital, Acetaminophen And CaffeineLibertas Pharma, Inc.16-APR-12
Butalbital, Aspirin, Caffeine And Codeine PhosphateLannett Company, Inc.04-MAY-12
Butalbital, Acetaminophen, And CaffeineCardinal Health14-MAY-12
CafergotSandoz Inc14-MAY-12
Butalbital, Acetaminophen And CaffeineAmerican Health Packaging26-JUL-12
Caffeine CitrateSagent Pharmaceuticals16-AUG-12
Aspirin, Caffeine, And Dihydrocodeine BitartrateCaraco Pharmaceutical Laboratories, Ltd17-AUG-12
Butalbital, Acetaminophen, And CaffeineLannett Company, Inc.19-SEP-12
Butalbital, Acetaminophen And CaffeineCardinal Health24-SEP-12
Butalbital, Acetaminophen And CaffeineRebel Distributors Corp09-OCT-12
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateBryant Ranch Prepack12-OCT-12
Butalbital, Acetominophen And CaffeineBryant Ranch Prepack12-OCT-12
Butalbital, Aspirin, Caffeine And Codeine Phosphatebryant ranch prepack12-OCT-12
Medique Ccp Caffeine FreeUnifirst First Aid Corporation01-NOV-12
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateQualitest Pharmaceuticals05-NOV-12
CaffeineAAA Pharmaceutical, Inc.21-DEC-12
Butalbital, Aspirin And CaffeineBryant Ranch Prepack21-JAN-13
Butalbital, Acetaminophen And CaffeinePreferred Pharmaceuticals, Inc.30-JAN-13
Caffeine CitrateSagent Pharmaceuticals15-FEB-13
Butalbital, Acetaminophen And CaffeineBryant Ranch Prepack06-MAR-13
ErgotamineWest-Ward Pharmaceutical Corp10-APR-13
Butalbital, Aspirin And CaffeineA-S Medication Solutions LLC24-APR-13
Butalbital, Acetaminophen And CaffeineREMEDYREPACK INC. 06-MAY-13

Caffeine Case Reports

What Caffeine 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 Caffeine. 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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