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ULTRAM ER

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Ultram Er Adverse Events Reported to the FDA Over Time

How are Ultram Er adverse event reports trending over time?

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

Most Common Ultram Er Adverse Events Reported to the FDA

What are the most common Ultram Er adverse events reported to the FDA?

Dizziness
38 (4.48%)
Convulsion
34 (4%)
Nausea
33 (3.89%)
Vomiting
23 (2.71%)
Drug Ineffective
21 (2.47%)
Headache
18 (2.12%)
Transient Ischaemic Attack
18 (2.12%)
Hyperhidrosis
16 (1.88%)
Insomnia
16 (1.88%)
Asthenia
14 (1.65%)
Somnolence
12 (1.41%)
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Suicidal Ideation
12 (1.41%)
Vision Blurred
12 (1.41%)
Hallucination
10 (1.18%)
Loss Of Consciousness
10 (1.18%)
Agitation
9 (1.06%)
Confusional State
9 (1.06%)
Drug Interaction
9 (1.06%)
Dyspnoea
9 (1.06%)
Feeling Abnormal
9 (1.06%)
Heart Rate Increased
9 (1.06%)
Withdrawal Syndrome
9 (1.06%)
Grand Mal Convulsion
8 (.94%)
Hypersensitivity
8 (.94%)
Rash
8 (.94%)
Chest Pain
7 (.82%)
Diarrhoea
7 (.82%)
Overdose
7 (.82%)
Pain
7 (.82%)
Chills
6 (.71%)
Erectile Dysfunction
6 (.71%)
Hypertension
6 (.71%)
Swollen Tongue
6 (.71%)
Urinary Retention
6 (.71%)
Arthralgia
5 (.59%)
Chest Discomfort
5 (.59%)
Death
5 (.59%)
Dehydration
5 (.59%)
Disorientation
5 (.59%)
Drug Withdrawal Syndrome
5 (.59%)
Dysuria
5 (.59%)
Fatigue
5 (.59%)
Hallucination, Visual
5 (.59%)
Hypersomnia
5 (.59%)
Pruritus
5 (.59%)
Swelling Face
5 (.59%)
Abdominal Pain
4 (.47%)
Bronchitis
4 (.47%)
Disturbance In Attention
4 (.47%)
Intervertebral Disc Protrusion
4 (.47%)
Malaise
4 (.47%)
Medication Error
4 (.47%)
Muscle Disorder
4 (.47%)
Myalgia
4 (.47%)
Myocardial Infarction
4 (.47%)
Neck Pain
4 (.47%)
Speech Disorder
4 (.47%)
Accidental Overdose
3 (.35%)
Aggression
3 (.35%)
Anorexia
3 (.35%)
Anxiety
3 (.35%)
Back Pain
3 (.35%)
Cardiac Arrest
3 (.35%)
Cold Sweat
3 (.35%)
Cough
3 (.35%)
Delirium
3 (.35%)
Delusion
3 (.35%)
Diabetes Mellitus
3 (.35%)
Electrocardiogram Qt Prolonged
3 (.35%)
Grip Strength Decreased
3 (.35%)
Haemorrhage
3 (.35%)
Hallucination, Auditory
3 (.35%)
Ill-defined Disorder
3 (.35%)
Lower Limb Fracture
3 (.35%)
Muscle Twitching
3 (.35%)
Opiates Positive
3 (.35%)
Pharyngeal Oedema
3 (.35%)
Sedation
3 (.35%)
Serotonin Syndrome
3 (.35%)
Skin Burning Sensation
3 (.35%)
Sneezing
3 (.35%)
Suicide Attempt
3 (.35%)
Therapeutic Response Decreased
3 (.35%)
Tremor
3 (.35%)
Urinary Incontinence
3 (.35%)
Vertigo
3 (.35%)
Weight Decreased
3 (.35%)
Abasia
2 (.24%)
Adrenal Insufficiency
2 (.24%)
Antisocial Behaviour
2 (.24%)
Blood Cholesterol Increased
2 (.24%)
Blood Creatinine Increased
2 (.24%)
Blood Pressure Decreased
2 (.24%)
Blood Pressure Increased
2 (.24%)
Body Temperature Increased
2 (.24%)
Catatonia
2 (.24%)
Cerebrovascular Accident
2 (.24%)
Cognitive Disorder
2 (.24%)
Crepitations
2 (.24%)
Deafness Bilateral
2 (.24%)
Dependence
2 (.24%)

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

What are the most common Ultram Er adverse events reported to the FDA?

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

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

Pain
87
Drug Use For Unknown Indication
65
Back Pain
40
Osteoarthritis
20
Arthralgia
13
Product Used For Unknown Indication
9
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Arthritis
8
Fibromyalgia
8
Musculoskeletal Pain
5
Bone Pain
5
Abdominal Pain
3
Headache
3
Pain In Extremity
3
Inflammation
2
Spinal Compression Fracture
2
Nervous System Disorder
2
Neck Pain
2
Pelvic Pain
2
Myalgia
2
Meniscus Lesion
1
Migraine
1
Postoperative Analgesia
1
Medication Error
1
Ear Infection
1
Back Disorder
1
Carpal Tunnel Decompression
1
Analgesia
1
Dental Treatment
1
Temporomandibular Joint Syndrome
1
Rheumatoid Arthritis
1
Accident At Work
1
Knee Arthroplasty
1
Back Injury
1
Shoulder Pain
1
Surgery
1
Pain Management
1
Muscle Strain
1
Dysmenorrhoea
1
Spinal Column Stenosis
1
Occipital Neuralgia
1
Rotator Cuff Syndrome
1

Drug Labels

LabelLabelerEffective
Ultram ErRebel Distributors Corp01-DEC-10
Ultram ErOrtho-McNeil-Janssen Pharmaceuticals, Inc.08-FEB-11
Ultram ErLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-DEC-11
Ultram ErREMEDYREPACK INC. 01-MAR-12
Ultram ErLake Erie Medical & Surgical Supply DBA Quality Care Products LLC20-MAR-12
Ultram ErJanssen Pharmaceuticals, Inc.25-FEB-13

Ultram Er Case Reports

What Ultram Er 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 Ultram Er. 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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