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ACETAMINOPHEN AND CODEINE PHOSPHATE

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Acetaminophen And Codeine Phosphate Adverse Events Reported to the FDA Over Time

How are Acetaminophen And Codeine Phosphate adverse event reports trending over time?

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

Most Common Acetaminophen And Codeine Phosphate Adverse Events Reported to the FDA

What are the most common Acetaminophen And Codeine Phosphate adverse events reported to the FDA?

Completed Suicide
144 (4.27%)
Vomiting
72 (2.13%)
Overdose
57 (1.69%)
Drug Exposure During Pregnancy
48 (1.42%)
Loss Of Consciousness
41 (1.21%)
Drug Interaction
40 (1.18%)
Multiple Drug Overdose Intentional
40 (1.18%)
Drug Toxicity
37 (1.1%)
Drug Abuse
33 (.98%)
Dyspnoea
33 (.98%)
Cardiac Arrest
32 (.95%)
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Hypotension
30 (.89%)
Medication Error
29 (.86%)
Malaise
28 (.83%)
Alanine Aminotransferase Increased
27 (.8%)
Cardio-respiratory Arrest
27 (.8%)
Intra-uterine Death
27 (.8%)
Intentional Drug Misuse
26 (.77%)
Multiple Drug Overdose
26 (.77%)
Poisoning
26 (.77%)
Pyrexia
26 (.77%)
Somnolence
26 (.77%)
Confusional State
25 (.74%)
Dizziness
24 (.71%)
Metabolic Acidosis
24 (.71%)
Respiratory Arrest
24 (.71%)
Nausea
23 (.68%)
Acidosis
22 (.65%)
Back Pain
21 (.62%)
Congenital Multiplex Arthrogryposis
21 (.62%)
Drug Ineffective
21 (.62%)
Constipation
20 (.59%)
Death
20 (.59%)
Atrial Fibrillation
19 (.56%)
Intentional Overdose
18 (.53%)
Macrocytosis
18 (.53%)
Tachycardia
18 (.53%)
Hepatic Necrosis
17 (.5%)
Rash
17 (.5%)
Renal Failure
17 (.5%)
Diarrhoea
16 (.47%)
Hyperhidrosis
16 (.47%)
Hypoxia
16 (.47%)
Suicide Attempt
16 (.47%)
Unresponsive To Stimuli
16 (.47%)
Abdominal Pain
15 (.44%)
Deafness Neurosensory
15 (.44%)
Headache
15 (.44%)
Respiratory Failure
15 (.44%)
Aspartate Aminotransferase Increase...
14 (.41%)
Depressed Level Of Consciousness
14 (.41%)
Dry Mouth
14 (.41%)
Fall
14 (.41%)
Inadequate Analgesia
14 (.41%)
International Normalised Ratio Incr...
14 (.41%)
Liver Function Test Abnormal
14 (.41%)
Blood Pressure Increased
13 (.39%)
Dehydration
13 (.39%)
Drug Dependence
13 (.39%)
Neutropenia
13 (.39%)
Pruritus
13 (.39%)
Tinnitus
13 (.39%)
Tremor
13 (.39%)
Urticaria
13 (.39%)
White Blood Cell Count Decreased
13 (.39%)
Agitation
12 (.36%)
Blood Alkaline Phosphatase Increase...
12 (.36%)
Coma
12 (.36%)
Hypersensitivity
12 (.36%)
Swelling Face
12 (.36%)
Accidental Overdose
11 (.33%)
Cytolytic Hepatitis
11 (.33%)
Hallucination
11 (.33%)
Heart Rate Increased
11 (.33%)
Insomnia
11 (.33%)
Pain In Extremity
11 (.33%)
Pancreatitis Acute
11 (.33%)
Thirst
11 (.33%)
Abortion Spontaneous
10 (.3%)
Acute Hepatic Failure
10 (.3%)
Apnoea
10 (.3%)
Blood Creatine Phosphokinase Increa...
10 (.3%)
Depression
10 (.3%)
Gamma-glutamyltransferase Increased
10 (.3%)
Lethargy
10 (.3%)
Liver Injury
10 (.3%)
Pain
10 (.3%)
White Blood Cell Count Increased
10 (.3%)
Angioedema
9 (.27%)
Blood Creatinine Increased
9 (.27%)
Convulsion
9 (.27%)
Drug Dispensing Error
9 (.27%)
Hepatic Encephalopathy
9 (.27%)
Miosis
9 (.27%)
Oedema
9 (.27%)
Pregnancy
9 (.27%)
Sopor
9 (.27%)
Stevens-johnson Syndrome
9 (.27%)
Decreased Appetite
8 (.24%)
Drug Withdrawal Syndrome Neonatal
8 (.24%)
Electrocardiogram Abnormal
8 (.24%)

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This graph shows the top adverse events submitted to the FDA for Acetaminophen And Codeine Phosphate, 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 Acetaminophen And Codeine Phosphate 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 Acetaminophen And Codeine Phosphate

What are the most common Acetaminophen And Codeine Phosphate adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Acetaminophen And Codeine Phosphate, 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 Acetaminophen And Codeine Phosphate 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 Acetaminophen And Codeine Phosphate According to Those Reporting Adverse Events

Why are people taking Acetaminophen And Codeine Phosphate, according to those reporting adverse events to the FDA?

Pain
379
Product Used For Unknown Indication
347
Drug Use For Unknown Indication
262
Back Pain
115
Rheumatoid Arthritis
63
Analgesic Therapy
56
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Osteoarthritis
50
Arthralgia
45
Headache
39
Arthritis
29
Drug Exposure During Pregnancy
29
Migraine
23
Symphysiolysis
22
Pharyngitis Streptococcal
22
Neck Pain
16
Sciatica
15
Toothache
14
Ill-defined Disorder
11
Analgesic Effect
11
Suicide Attempt
11
Bone Pain
10
Analgesia
9
Musculoskeletal Pain
9
Spinal Osteoarthritis
8
Overdose
8
Neuralgia
7
Muscle Spasms
7
Fibromyalgia
7
Abdominal Pain
7
Pain In Extremity
6
Knee Arthroplasty
6
Angiopathy
6
Insomnia
6
Pubic Pain
5
Muscle Strain
5
Anxiety
5
Post Procedural Pain
5
Procedural Pain
4
Abdominal Pain Lower
4
Chest Pain
4
Skin Lesion
4
Diabetic Neuropathy
4
Cancer Pain
4
Abdominal Pain Upper
3
Tonsillectomy
3
Tooth Abscess
3
Postoperative Analgesia
3
Tendonitis
3
Cough
3
Pyrexia
3
Inflammation
2

Drug Labels

LabelLabelerEffective
Acetaminophen And CodeinePD-Rx Pharmaceuticals, Inc.01-SEP-09
Butalbital, Acetaminophen, Caffeine And Codeine PhosphateBreckenridge Pharmaceutical, Inc.20-OCT-09
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphatePhysicians Total Care, Inc.22-OCT-09
Acetaminophen And Codeine PhosphateBryant Ranch Prepack17-NOV-09
Acetaminophen And Codeine PhosphateRebel Distributors Corp.01-DEC-09
Acetaminophen And Codeine PhosphateMcKesson Packaging Services Business Unit of McKesson Corporation14-DEC-09
Acetaminophen And Codeine PhosphateContract Pharmacy Services-PA16-FEB-10
Acetaminophen And Codeine PhosphateSTAT RX USA LLC15-MAR-10
Acetaminophen And Codeine PhosphateApotheca, Inc.08-JUN-10
Cocet PlusPoly Pharmaceuticals29-JUN-10
Acetaminophen And CodeineSTAT RX USA LLC26-JUL-10
Acetaminophen And CodeineKeltman Pharmaceuticals Inc.09-AUG-10
Acetaminophen And Codeine PhosphateRebel Distributors Corp.31-AUG-10
Acetaminophen And CodeineBlenheim Pharmacal, Inc.14-OCT-10
Acetaminophen And Codeine PhosphatePhysicians Total Care, Inc.10-NOV-10
Tylenol With CodeineCardinal Health07-DEC-10
Acetaminophen And Codeine PhosphateBlenheim Pharmacal, Inc.19-APR-11
Acetaminophen And Codeine PhosphateCardinal Health12-MAY-11
Acetaminophen And CodeineAmneal Pharmaceuticals18-MAY-11
Acetaminophen And Codeine Unit Dose Services18-MAY-11
Acetaminophen And Codeine PhosphateRedPharm Drug Inc.20-MAY-11
Acetaminophen And CodeineRedPharm Drug Inc.24-MAY-11
Acetaminophen And Codeine PhosphateRedPharm Drug Inc.10-JUN-11
Acetaminophen And Codeine PhosphateMorton Grove Pharmaceuticals, Inc.08-JUL-11
Acetaminophen And CodeinePD-Rx Pharmaceuticals, Inc.13-JUL-11
Acetaminophen And CodeinePD-Rx Pharmaceuticals, Inc.13-JUL-11
Acetaminophen And CodeinePD-Rx Pharmaceuticals, Inc.14-JUL-11
Butalbital, Acetaminophen And Caffeine With Codeine PhosphateWest-ward Pharmaceutical Corp15-JUL-11
Tylenol With CodeinePD-Rx Pharmaceuticals, Inc.26-JUL-11
Acetaminophen And Codeine PhosphateQualitest Pharmaceuticals01-AUG-11
Acetaminophen And Codeine PhosphatePharmaceutical Associates, Inc.04-AUG-11
Fioricet With CodeineWatson Pharma, Inc.22-SEP-11
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateWatson Laboratories, Inc.22-SEP-11
Capital And CodeineValeant Pharmaceuticals International29-SEP-11
Acetaminophen And Codeine PhosphateDispensing Solutions, Inc.30-SEP-11
Acetaminophen And CodeineContract Pharmacy Services-PA03-OCT-11
Butalbital, Acetaminophen, Caffeine And Codeine PhosphateDispensing Solutions, Inc.03-OCT-11
Acetaminophen And Codeine PhosphateMcKesson Contract Packaging21-OCT-11
Acetaminophen And Codeine PhosphateCardinal Health27-OCT-11
Acetaminophen And Codeine PhosphateMylan Institutional Inc.09-DEC-11
Acetaminophen And Codeine PhosphateRebel Distributors Corp13-DEC-11
Acetaminophen And Codeine PhosphateLake Erie Medical & Surgical Supply DBA Quality Care Products LLC15-DEC-11
Acetaminophen And Codeine PhosphateRebel Distributors Corp24-JAN-12
Acetaminophen And Codeine PhosphateCardinal Health25-JAN-12
Acetaminophen And CodeineH.J. Harkins Company, Inc.31-JAN-12
Acetaminophen And CodeineDispensing Solutions, Inc.07-FEB-12
Acetaminophen And Codeine PhosphateAmerican Health Packaging10-APR-12
Acetaminophen And Codeine PhosphateAtlantic Biologicals Corps12-APR-12
Acetaminophen And Codeine PhosphateHi-Tech Pharmacal Co., Inc.12-APR-12
Acetaminophen And Codeine PhosphateCardinal Health14-MAY-12
Acetaminophen And Codeine PhosphateTeva Pharmaceuticals USA Inc03-JUL-12
Acetaminophen And CodeineAidarex Pharmaceuticals LLC12-SEP-12
Acetaminophen And Codeine PhosphatePhysicians Total Care, Inc.24-SEP-12
Tylenol With CodeineJanssen Pharmaceuticals, Inc.27-SEP-12
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateBryant Ranch Prepack12-OCT-12
Butalbital, Acetaminophen, Caffeine, And Codeine PhosphateQualitest Pharmaceuticals05-NOV-12
Acetaminophen And Codeine PhosphateMallinckrodt, Inc.14-NOV-12
Acetaminophen And CodeineQualitest Pharmaceuticals16-NOV-12
Acetaminophen And CodeineQualitest Pharmaceuticals16-NOV-12
Acetaminophen And Codeine PhosphatePreferred Pharmaceuticals, Inc14-JAN-13
Acetaminophen And Codeine PhosphateBryant Ranch Prepack17-JAN-13
Acetaminophen And Codeine PhosphatePreferred Pharmaceuticals, Inc21-JAN-13
Acetaminophen And Codeine PhosphateBryant Ranch Prepack21-JAN-13
Tylenol With CodeineA-S Medication Solutions LLC27-FEB-13
Acetaminophen And CodeineQualitest Pharmaceuticals28-FEB-13
Acetaminophen And CodeineA-S Medication Solutions LLC02-MAR-13
Acetaminophen And CodeineA-S Medication Solutions LLC02-MAR-13
Acetaminophen And CodeineA-S Medication Solutions LLC02-MAR-13
Acetaminophen And Codeine PhosphateREMEDYREPACK INC. 04-APR-13
Acetaminophen And Codeine PhosphateCardinal Health17-APR-13
Acetaminophen And Codeine PhosphatePreferred Pharmaceuticals, Inc24-APR-13
Acetaminophen And Codeine PhosphateA-S Medication Solutions LLC27-APR-13
Tylenol With CodeineJanssen Pharmaceuticals, Inc.01-MAY-13

Acetaminophen And Codeine Phosphate Case Reports

What Acetaminophen And Codeine Phosphate 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 Acetaminophen And Codeine Phosphate. 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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