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BACTRIM

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Bactrim Adverse Events Reported to the FDA Over Time

How are Bactrim adverse event reports trending over time?

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

Most Common Bactrim Adverse Events Reported to the FDA

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

Pyrexia
455 (2.64%)
Renal Failure Acute
250 (1.45%)
Rash
249 (1.45%)
Stevens-johnson Syndrome
205 (1.19%)
Thrombocytopenia
203 (1.18%)
Nausea
196 (1.14%)
Diarrhoea
179 (1.04%)
Neutropenia
168 (.98%)
Vomiting
167 (.97%)
Drug Hypersensitivity
156 (.91%)
Pruritus
150 (.87%)
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Pancytopenia
148 (.86%)
Renal Failure
141 (.82%)
Headache
139 (.81%)
Asthenia
133 (.77%)
Alanine Aminotransferase Increased
127 (.74%)
Anaemia
123 (.71%)
Dyspnoea
123 (.71%)
Erythema
117 (.68%)
Aspartate Aminotransferase Increase...
115 (.67%)
Hyperkalaemia
113 (.66%)
Rash Maculo-papular
106 (.62%)
Chills
102 (.59%)
Leukopenia
102 (.59%)
Agranulocytosis
101 (.59%)
Blood Creatinine Increased
99 (.57%)
Fatigue
93 (.54%)
Cytolytic Hepatitis
91 (.53%)
Drug Interaction
90 (.52%)
Toxic Epidermal Necrolysis
89 (.52%)
Pain
88 (.51%)
Urticaria
84 (.49%)
Abdominal Pain
83 (.48%)
Drug Rash With Eosinophilia And Sys...
83 (.48%)
Weight Decreased
79 (.46%)
Confusional State
78 (.45%)
Hypotension
78 (.45%)
Bone Marrow Failure
75 (.44%)
Myalgia
75 (.44%)
Arthralgia
74 (.43%)
Dehydration
73 (.42%)
Toxic Skin Eruption
72 (.42%)
Rash Erythematous
71 (.41%)
Dizziness
70 (.41%)
Malaise
69 (.4%)
Platelet Count Decreased
68 (.39%)
Hypersensitivity
67 (.39%)
Oedema Peripheral
67 (.39%)
Cholestasis
66 (.38%)
Condition Aggravated
66 (.38%)
Rash Generalised
66 (.38%)
White Blood Cell Count Decreased
64 (.37%)
Gamma-glutamyltransferase Increased
63 (.37%)
General Physical Health Deteriorati...
63 (.37%)
Urinary Tract Infection
63 (.37%)
Pneumocystis Jiroveci Pneumonia
59 (.34%)
Jaundice
58 (.34%)
Eosinophilia
57 (.33%)
International Normalised Ratio Incr...
57 (.33%)
Haemoglobin Decreased
56 (.33%)
Lymphopenia
56 (.33%)
Pain In Extremity
56 (.33%)
Skin Exfoliation
56 (.33%)
Blood Bilirubin Increased
54 (.31%)
Blood Alkaline Phosphatase Increase...
53 (.31%)
Rash Pruritic
51 (.3%)
Hyponatraemia
50 (.29%)
Sepsis
49 (.28%)
Drug Ineffective
48 (.28%)
Pneumonia
48 (.28%)
Renal Impairment
48 (.28%)
Convulsion
47 (.27%)
Hepatitis
47 (.27%)
Loss Of Consciousness
47 (.27%)
Blood Lactate Dehydrogenase Increas...
46 (.27%)
Cough
46 (.27%)
Hepatic Failure
46 (.27%)
Septic Shock
45 (.26%)
Immune Reconstitution Syndrome
44 (.26%)
Decreased Appetite
43 (.25%)
Febrile Neutropenia
43 (.25%)
C-reactive Protein Increased
42 (.24%)
Hepatitis Cholestatic
41 (.24%)
Insomnia
41 (.24%)
Liver Function Test Abnormal
41 (.24%)
Tremor
41 (.24%)
Blister
39 (.23%)
Hypertension
39 (.23%)
Burning Sensation
38 (.22%)
Hepatic Enzyme Increased
38 (.22%)
Coma
37 (.21%)
Fall
37 (.21%)
Lung Disorder
37 (.21%)
Pulmonary Embolism
37 (.21%)
Somnolence
37 (.21%)
Anorexia
36 (.21%)
Dermatitis Exfoliative
36 (.21%)
Hyperhidrosis
36 (.21%)
Tachycardia
36 (.21%)
Blood Sodium Decreased
35 (.2%)
Liver Disorder
35 (.2%)

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

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

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

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

Prophylaxis
1038
Drug Use For Unknown Indication
1022
Product Used For Unknown Indication
637
Urinary Tract Infection
558
Antifungal Prophylaxis
530
Infection Prophylaxis
455
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Antibiotic Prophylaxis
250
Pneumocystis Jiroveci Pneumonia
238
Infection
201
Staphylococcal Infection
100
Sinusitis
99
Hiv Infection
81
Cellulitis
69
Pneumonia
67
Acne
48
Antibiotic Therapy
45
Ill-defined Disorder
43
Cystitis
42
Opportunistic Infection Prophylaxis
36
Prostatitis
35
Bronchitis
34
Skin Infection
23
Skin Ulcer
22
Bacterial Infection
22
Nocardiosis
21
Pneumocystis Jiroveci Infection
19
Anti-infective Therapy
18
Pyelonephritis
17
Kidney Infection
17
Pneumocystis Carinii Pneumonia
17
Enteritis Infectious
16
Abscess
14
Pyrexia
13
Cough
13
Renal Transplant
13
Furuncle
13
Prophylactic Chemotherapy
13
Folliculitis
12
Lung Infection
12
Toxoplasmosis
11
Interstitial Lung Disease
11
Ear Infection
11
Respiratory Tract Infection
11
Sepsis
11
Cerebral Toxoplasmosis
10
Diarrhoea
10
Prophylaxis Urinary Tract Infection
10
Prophylaxis Against Hiv Infection
10
Otitis Media
9
Chronic Lymphocytic Leukaemia
9
Antibacterial Prophylaxis
9

Drug Labels

LabelLabelerEffective
Bactrim DsPhysicians Total Care, Inc.30-SEP-09
Bactrim DsAR Scientific, Inc.24-AUG-12
BactrimAR Scientific, Inc.24-AUG-12

Bactrim Case Reports

What Bactrim 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 Bactrim. 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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