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Treximet Adverse Events Reported to the FDA Over Time

How are Treximet adverse event reports trending over time?

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

Most Common Treximet Adverse Events Reported to the FDA

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

Completed Suicide
412 (1.8%)
No Adverse Event
390 (1.7%)
Nausea
343 (1.5%)
Drug Ineffective
340 (1.48%)
Gastrointestinal Haemorrhage
267 (1.16%)
Renal Failure Acute
264 (1.15%)
Vomiting
248 (1.08%)
Dyspnoea
237 (1.03%)
Dizziness
232 (1.01%)
Headache
229 (1%)
Pain
215 (.94%)
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Haemoglobin Decreased
192 (.84%)
Diarrhoea
186 (.81%)
Rash
170 (.74%)
Haematemesis
164 (.72%)
Gastric Ulcer
159 (.69%)
Anaemia
158 (.69%)
Abdominal Pain
155 (.68%)
Chest Pain
155 (.68%)
Drug Toxicity
145 (.63%)
Hypotension
142 (.62%)
Abdominal Pain Upper
141 (.62%)
Asthenia
137 (.6%)
Cardiac Arrest
137 (.6%)
Respiratory Arrest
132 (.58%)
Hypersensitivity
129 (.56%)
Abdominal Discomfort
128 (.56%)
Malaise
127 (.55%)
Feeling Abnormal
126 (.55%)
Death
124 (.54%)
Pruritus
122 (.53%)
Urticaria
120 (.52%)
Somnolence
118 (.51%)
Arthralgia
117 (.51%)
Pyrexia
117 (.51%)
Overdose
115 (.5%)
Melaena
112 (.49%)
Duodenal Ulcer
108 (.47%)
Rectal Haemorrhage
107 (.47%)
Fatigue
103 (.45%)
Gastric Haemorrhage
103 (.45%)
Oedema Peripheral
100 (.44%)
Drug Interaction
99 (.43%)
Pain In Extremity
97 (.42%)
Back Pain
95 (.41%)
Suicide Attempt
93 (.41%)
Drug Hypersensitivity
90 (.39%)
Confusional State
89 (.39%)
Haemorrhage
88 (.38%)
Upper Gastrointestinal Haemorrhage
87 (.38%)
Renal Failure
84 (.37%)
Condition Aggravated
79 (.34%)
Asthma
78 (.34%)
Hyperhidrosis
77 (.34%)
Vision Blurred
77 (.34%)
Loss Of Consciousness
76 (.33%)
Hyperkalaemia
75 (.33%)
Faeces Discoloured
74 (.32%)
Tachycardia
74 (.32%)
Heart Rate Increased
73 (.32%)
Haematochezia
72 (.31%)
Constipation
70 (.31%)
Hypoaesthesia
68 (.3%)
Cardio-respiratory Arrest
67 (.29%)
Paraesthesia
67 (.29%)
Chest Discomfort
66 (.29%)
Muscular Weakness
66 (.29%)
Myocardial Infarction
66 (.29%)
Blood Creatinine Increased
65 (.28%)
Anxiety
64 (.28%)
Hyponatraemia
64 (.28%)
Insomnia
64 (.28%)
Osteoarthritis
64 (.28%)
Atrial Fibrillation
62 (.27%)
Dehydration
62 (.27%)
Hypertension
62 (.27%)
Multiple Drug Overdose
62 (.27%)
Syncope
62 (.27%)
Urinary Tract Infection
62 (.27%)
Tremor
59 (.26%)
Weight Decreased
59 (.26%)
Drug Exposure During Pregnancy
58 (.25%)
Gastric Ulcer Haemorrhage
58 (.25%)
Gastritis
58 (.25%)
Angioedema
57 (.25%)
Burning Sensation
57 (.25%)
Myalgia
57 (.25%)
Pneumonia
57 (.25%)
Agitation
56 (.24%)
Blood Pressure Increased
56 (.24%)
Musculoskeletal Stiffness
56 (.24%)
Poisoning
55 (.24%)
Dyspepsia
54 (.24%)
Lip Swelling
54 (.24%)
Swelling
54 (.24%)
Migraine
53 (.23%)
Swelling Face
53 (.23%)
Lethargy
52 (.23%)
Palpitations
52 (.23%)
Stevens-johnson Syndrome
51 (.22%)
Anaphylactic Reaction
50 (.22%)

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

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

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

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

Pain
1414
Product Used For Unknown Indication
1305
Drug Use For Unknown Indication
1210
Rheumatoid Arthritis
751
Arthritis
648
Migraine
632
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Osteoarthritis
535
Back Pain
414
Arthralgia
404
Headache
361
Inflammation
137
Premedication
132
Analgesic Therapy
130
Juvenile Arthritis
97
Dysmenorrhoea
95
Antiinflammatory Therapy
91
Pain In Extremity
91
Musculoskeletal Pain
86
Gout
70
Pyrexia
48
Myalgia
48
Psoriatic Arthropathy
47
Suicide Attempt
46
Ill-defined Disorder
45
Toothache
45
Ankylosing Spondylitis
44
Fibromyalgia
41
Nasopharyngitis
39
Cancer Pain
38
Neck Pain
34
Tumour Associated Fever
32
Muscle Spasms
31
Swelling
28
Sciatica
28
Chest Pain
26
Pain Management
25
Tendonitis
22
Back Disorder
22
Abdominal Pain
19
Arthropathy
19
Polyarthritis
18
Pain In Jaw
17
Joint Injury
17
Spondylitis
17
Bone Pain
16
Musculoskeletal Chest Pain
16
Phlebitis
15
Procedural Pain
14
Intervertebral Disc Degeneration
14
Diabetes Mellitus
13
Neuropathy Peripheral
12

Drug Labels

LabelLabelerEffective
TreximetRebel Distributors Corp13-SEP-11
TreximetGlaxoSmithKline LLC07-NOV-12

Treximet Case Reports

What Treximet 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 Treximet. 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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