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TRAMADOL AND ACETAMINOPHEN

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Tramadol And Acetaminophen Adverse Events Reported to the FDA Over Time

How are Tramadol And Acetaminophen adverse event reports trending over time?

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

Most Common Tramadol And Acetaminophen Adverse Events Reported to the FDA

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

Nausea
124 (2.82%)
Drug Interaction
95 (2.16%)
Somnolence
87 (1.98%)
Vomiting
86 (1.95%)
Dizziness
85 (1.93%)
Loss Of Consciousness
84 (1.91%)
Fall
76 (1.73%)
Malaise
57 (1.29%)
Confusional State
56 (1.27%)
Dyspnoea
55 (1.25%)
Multiple Drug Overdose Intentional
52 (1.18%)
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Hyperhidrosis
43 (.98%)
Completed Suicide
42 (.95%)
Renal Failure Acute
41 (.93%)
Constipation
38 (.86%)
Pyrexia
38 (.86%)
Rhabdomyolysis
38 (.86%)
Drug Ineffective
35 (.79%)
Bradycardia
34 (.77%)
Withdrawal Syndrome
34 (.77%)
Convulsion
29 (.66%)
Headache
29 (.66%)
Suicide Attempt
29 (.66%)
Depressed Level Of Consciousness
28 (.64%)
Overdose
28 (.64%)
Abnormal Behaviour
27 (.61%)
Cytolytic Hepatitis
27 (.61%)
Syncope
27 (.61%)
Decreased Appetite
26 (.59%)
Coma
25 (.57%)
Hyponatraemia
25 (.57%)
Drug Eruption
24 (.54%)
Fatigue
24 (.54%)
Gastric Ulcer
24 (.54%)
Inadequate Analgesia
24 (.54%)
Feeling Abnormal
23 (.52%)
Asthenia
22 (.5%)
Hypoglycaemia
22 (.5%)
Pain
22 (.5%)
Vertigo
20 (.45%)
Gastritis
19 (.43%)
Hallucination
19 (.43%)
Urinary Retention
19 (.43%)
Agranulocytosis
18 (.41%)
Intentional Overdose
18 (.41%)
Multiple Drug Overdose
18 (.41%)
Palpitations
18 (.41%)
Pollakiuria
18 (.41%)
Respiratory Acidosis
18 (.41%)
Alanine Aminotransferase Increased
17 (.39%)
Aspartate Aminotransferase Increase...
17 (.39%)
Insomnia
17 (.39%)
Liver Function Test Abnormal
17 (.39%)
Altered State Of Consciousness
16 (.36%)
Hypokalaemia
16 (.36%)
Hypotension
16 (.36%)
Liver Injury
16 (.36%)
Tremor
16 (.36%)
Cardiac Arrest
15 (.34%)
Chest Discomfort
15 (.34%)
Death
15 (.34%)
Disorientation
15 (.34%)
Dysuria
15 (.34%)
Renal Failure
15 (.34%)
Speech Disorder
15 (.34%)
Visual Acuity Reduced
15 (.34%)
Anxiety
14 (.32%)
Delirium
14 (.32%)
Dyskinesia
14 (.32%)
Hepatitis
14 (.32%)
International Normalised Ratio Incr...
14 (.32%)
Miosis
14 (.32%)
Pruritus
14 (.32%)
Tachycardia
14 (.32%)
Abdominal Discomfort
13 (.3%)
Agitation
13 (.3%)
Drug Prescribing Error
13 (.3%)
Haemorrhage Subcutaneous
13 (.3%)
Hospitalisation
13 (.3%)
Incorrect Dose Administered
13 (.3%)
Anaphylactic Reaction
12 (.27%)
Bradypnoea
12 (.27%)
Dementia
12 (.27%)
Drug Level Increased
12 (.27%)
Hot Flush
12 (.27%)
Myoclonus
12 (.27%)
Pneumonia
12 (.27%)
Serotonin Syndrome
12 (.27%)
Visual Impairment
12 (.27%)
Abdominal Pain
11 (.25%)
Acute Respiratory Failure
11 (.25%)
Anaemia
11 (.25%)
Arthralgia
11 (.25%)
Cholestasis
11 (.25%)
Diarrhoea
11 (.25%)
Drug Dependence
11 (.25%)
Drug Toxicity
11 (.25%)
Gamma-glutamyltransferase Increased
11 (.25%)
Hyperglycaemia
11 (.25%)
Hypertension
11 (.25%)
Muscle Rigidity
11 (.25%)

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

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

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

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

Pain
476
Product Used For Unknown Indication
337
Back Pain
90
Drug Use For Unknown Indication
71
Arthralgia
51
Rheumatoid Arthritis
37
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Osteoarthritis
23
Sciatica
16
Ill-defined Disorder
16
Analgesic Therapy
15
Toothache
15
Neuralgia
14
Procedural Pain
14
Musculoskeletal Pain
13
Headache
10
Fibromyalgia
10
Bone Pain
10
Arthritis
9
Neck Pain
9
Suicide Attempt
9
Post Herpetic Neuralgia
9
Pain In Extremity
8
Crohns Disease
8
Foetal Exposure During Pregnancy
8
Abdominal Pain
7
Intentional Overdose
7
Abdominal Pain Upper
6
Cervicobrachial Syndrome
6
Intervertebral Disc Protrusion
6
Intentional Self-injury
5
Cancer Pain
4
Pain Management
4
Migraine
4
Rib Fracture
4
Neuropathy Peripheral
4
Renal Colic
4
Tibia Fracture
4
Muscle Rupture
3
Nerve Compression
3
Asthma
3
Limb Injury
3
Exostosis
3
Pharyngolaryngeal Pain
3
Completed Suicide
3
Contusion
3
Pyrexia
3
Drug Exposure During Pregnancy
3
Dementia
3
Trigeminal Neuralgia
3
Dementia Alzheimers Type
2
Depression
2

Drug Labels

LabelLabelerEffective
Tramadol Hydrochloride And AcetaminophenMylan Pharmaceuticals Inc.13-AUG-08
Tramadol Hydrochloride And AcetaminophenBryant Ranch Prepack17-DEC-09
Tramadol Hydrochloride And Acetaminophen PD-Rx Pharmaceuticals, Inc.17-DEC-09
Tramadol Hydrochloride And AcetaminophenPhysicians Total Care, Inc.13-MAY-10
Tramadol Hydrochloride And AcetaminophenKeltman Pharmaceuticals Inc.20-JUL-10
UltracetRebel Distributors Corp01-DEC-10
Tramadol Hydrochloride And AcetaminophenRebel Distributors Corp01-DEC-10
Tramadol Hydrochloride And Acetaminophen Preferred Pharmaceuticals, Inc31-MAR-11
Tramadol Hydrochloride And Acetaminophen AvPAK19-MAY-11
UltracetPD-Rx Pharmaceuticals, Inc.04-AUG-11
Tramadol Hydrochloride And AcetaminophenREMEDYREPACK INC. 05-DEC-11
Tramadol Hydrochloride And AcetaminophenRebel Distributors Corp20-DEC-11
Tramadol Hydrochloride And AcetaminophenSTAT Rx USA LLC14-FEB-12
Tramadol Hydrochloride And AcetaminophenAlvogen, Inc.14-FEB-12
UltracetLake Erie Medical & Surgical Supply DBA Quality Care Products LLC20-MAR-12
Tramadol Hydrochloride And Acetaminophen H.J. Harkins Company, Inc.19-APR-12
Tramadol Hydrochloride And AcetaminophenPar Pharmaceutical Inc.21-APR-12
Tramadol Hydrochloride And AcetaminophenAmneal Pharmaceuticals23-MAY-12
Tramadol Hydrochloride And AcetaminophenCaraco Pharmaceutical Laboratories, Ltd.14-JUN-12
Tramadol Hydrochloride And AcetaminophenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC26-JUN-12
Tramadol Hydrochloride And AcetaminophenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC12-JUL-12
Tramadol Hydrochloride And AcetaminophenAmerican Health Packaging20-JUL-12
Tramadol Hydrochloride And AcetaminophenLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-JUL-12
Tramadol Hydrochloride And AcetaminophenSTAT Rx USA LLC22-AUG-12
UltracetPhysicians Total Care, Inc.29-AUG-12
Tramadol Hydrochloride And AcetaminophenIVAX Pharmaceuticals, Inc10-SEP-12
Tramadol Hydrochloride And AcetaminophenZydus Pharmaceuticals (USA) Inc.18-SEP-12
Tramadol Hydrochloride And AcetaminophenCadila Healthcare Limited01-OCT-12
Tramadol Hydrochloride And AcetaminophenAidarex Pharmaceuticals LLC05-OCT-12
Tramadol Hydrochloride And AcetaminophenMicro Labs Limited22-DEC-12
UltracetJanssen Pharmaceuticals, Inc.26-FEB-13
Tramadol Hydrochloride And AcetaminophenIVAX Pharmaceuticals, Inc.27-FEB-13

Tramadol And Acetaminophen Case Reports

What Tramadol And Acetaminophen 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 Tramadol And Acetaminophen. 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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