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Ultram Adverse Events Reported to the FDA Over Time

How are Ultram adverse event reports trending over time?

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

Most Common Ultram Adverse Events Reported to the FDA

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

Drug Interaction
916 (1.95%)
Convulsion
900 (1.92%)
Completed Suicide
789 (1.68%)
Nausea
767 (1.64%)
Vomiting
681 (1.45%)
Confusional State
617 (1.32%)
Overdose
603 (1.29%)
Somnolence
602 (1.28%)
Dizziness
591 (1.26%)
Serotonin Syndrome
438 (.93%)
Drug Ineffective
427 (.91%)
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Loss Of Consciousness
413 (.88%)
Fall
402 (.86%)
Drug Toxicity
391 (.83%)
Headache
389 (.83%)
Dyspnoea
384 (.82%)
Hyperhidrosis
372 (.79%)
Pain
350 (.75%)
Cardiac Arrest
338 (.72%)
Death
328 (.7%)
Multiple Drug Overdose
327 (.7%)
Suicide Attempt
320 (.68%)
Cardio-respiratory Arrest
310 (.66%)
Tachycardia
310 (.66%)
Insomnia
306 (.65%)
Tremor
302 (.64%)
Hypotension
301 (.64%)
Respiratory Arrest
299 (.64%)
Hallucination
291 (.62%)
Asthenia
276 (.59%)
Malaise
270 (.58%)
Agitation
262 (.56%)
Fatigue
262 (.56%)
Intentional Overdose
259 (.55%)
Constipation
256 (.55%)
Drug Abuse
253 (.54%)
Drug Abuser
249 (.53%)
Drug Withdrawal Syndrome
246 (.52%)
Anxiety
229 (.49%)
Coma
229 (.49%)
Pyrexia
229 (.49%)
Grand Mal Convulsion
223 (.48%)
Drug Dependence
219 (.47%)
Feeling Abnormal
213 (.45%)
Depressed Level Of Consciousness
207 (.44%)
Depression
207 (.44%)
Renal Failure Acute
201 (.43%)
Hypertension
188 (.4%)
Respiratory Depression
187 (.4%)
Diarrhoea
186 (.4%)
Multiple Drug Overdose Intentional
186 (.4%)
Unresponsive To Stimuli
184 (.39%)
Delirium
180 (.38%)
Disorientation
180 (.38%)
Abdominal Pain
177 (.38%)
Withdrawal Syndrome
175 (.37%)
Hyponatraemia
173 (.37%)
Pruritus
165 (.35%)
Intentional Drug Misuse
163 (.35%)
Suicidal Ideation
163 (.35%)
Hypoglycaemia
162 (.35%)
Back Pain
156 (.33%)
Condition Aggravated
152 (.32%)
Chest Pain
139 (.3%)
Bradycardia
138 (.29%)
Syncope
135 (.29%)
Dehydration
133 (.28%)
Decreased Appetite
129 (.28%)
Heart Rate Increased
129 (.28%)
Weight Decreased
129 (.28%)
Abnormal Behaviour
126 (.27%)
Arthralgia
125 (.27%)
Gait Disturbance
125 (.27%)
Aggression
124 (.26%)
Myoclonus
124 (.26%)
Rhabdomyolysis
124 (.26%)
Dyskinesia
123 (.26%)
Hallucination, Visual
123 (.26%)
Drug Exposure During Pregnancy
121 (.26%)
Muscle Spasms
120 (.26%)
Rash
115 (.25%)
Pneumonia
114 (.24%)
Pain In Extremity
113 (.24%)
Speech Disorder
112 (.24%)
International Normalised Ratio Incr...
111 (.24%)
Oedema Peripheral
111 (.24%)
Psychotic Disorder
108 (.23%)
Miosis
107 (.23%)
Road Traffic Accident
107 (.23%)
Dysarthria
106 (.23%)
Renal Failure
106 (.23%)
Myocardial Infarction
105 (.22%)
Amnesia
104 (.22%)
Palpitations
104 (.22%)
Blood Pressure Increased
102 (.22%)
Medication Error
101 (.22%)
Hallucination, Auditory
100 (.21%)
Cytolytic Hepatitis
99 (.21%)
Poisoning
99 (.21%)
Pulmonary Oedema
99 (.21%)
Vision Blurred
99 (.21%)

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

What are the most common Ultram 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, 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 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 According to Those Reporting Adverse Events

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

Pain
5940
Drug Use For Unknown Indication
3070
Product Used For Unknown Indication
3066
Back Pain
1368
Arthralgia
621
Rheumatoid Arthritis
367
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Osteoarthritis
358
Arthritis
310
Analgesic Therapy
277
Fibromyalgia
257
Headache
252
Abdominal Pain
237
Neck Pain
165
Pain In Extremity
164
Ill-defined Disorder
149
Neuralgia
122
Suicide Attempt
116
Bone Pain
113
Migraine
112
Procedural Pain
100
Sciatica
100
Pain Management
95
Musculoskeletal Pain
84
Breakthrough Pain
77
Cancer Pain
76
Analgesic Effect
76
Analgesia
74
Neuropathy Peripheral
66
Myalgia
65
Intervertebral Disc Protrusion
58
Ankylosing Spondylitis
49
Postoperative Analgesia
48
Crohns Disease
45
Intentional Overdose
44
Chest Pain
43
Back Disorder
41
Drug Exposure During Pregnancy
40
Intentional Drug Misuse
39
Toothache
34
Abdominal Pain Upper
34
Overdose
32
Intervertebral Disc Degeneration
32
Dysmenorrhoea
30
Discomfort
29
Back Injury
29
Psoriatic Arthropathy
28
Herpes Zoster
26
Spinal Column Stenosis
26
Pain Prophylaxis
25
Restless Legs Syndrome
24
Depression
22

Drug Labels

LabelLabelerEffective
UltramPD-Rx Pharmaceuticals, Inc.11-OCT-10
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
UltramPhysicians Total Care, Inc.01-MAY-12
UltramLake Erie Medical DBA Quality Care Products LLC28-NOV-12
Ultram ErJanssen Pharmaceuticals, Inc.25-FEB-13
UltramJanssen Pharmaceuticals, Inc.25-FEB-13

Ultram Case Reports

What Ultram 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. 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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