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Antibiotics Adverse Events Reported to the FDA Over Time

How are Antibiotics adverse event reports trending over time?

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

Most Common Antibiotics Adverse Events Reported to the FDA

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

Diarrhoea
78 (1.31%)
Pyrexia
77 (1.29%)
Vomiting
74 (1.24%)
Drug Ineffective
72 (1.21%)
Malaise
71 (1.19%)
Nausea
68 (1.14%)
Pneumonia
64 (1.07%)
Weight Decreased
64 (1.07%)
Pain
63 (1.06%)
Rash
48 (.8%)
Dizziness
45 (.75%)
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Fatigue
41 (.69%)
Dehydration
40 (.67%)
Dyspnoea
40 (.67%)
Urinary Tract Infection
40 (.67%)
Drug Interaction
39 (.65%)
Alanine Aminotransferase Increased
38 (.64%)
Asthenia
36 (.6%)
Oedema Peripheral
36 (.6%)
Condition Aggravated
35 (.59%)
Cough
33 (.55%)
Hypersensitivity
33 (.55%)
Loss Of Consciousness
33 (.55%)
Drug Exposure During Pregnancy
32 (.54%)
Drug Hypersensitivity
32 (.54%)
Headache
31 (.52%)
Infection
31 (.52%)
Pain In Extremity
30 (.5%)
Pruritus
29 (.49%)
Fall
28 (.47%)
Abdominal Pain Upper
27 (.45%)
Erythema
26 (.44%)
Liver Function Test Abnormal
26 (.44%)
Renal Failure
26 (.44%)
Sepsis
25 (.42%)
Aspartate Aminotransferase Increase...
24 (.4%)
Bronchitis
24 (.4%)
Abdominal Pain
23 (.39%)
Clostridial Infection
23 (.39%)
Hypotension
23 (.39%)
Convulsion
22 (.37%)
Anxiety
21 (.35%)
Renal Impairment
21 (.35%)
Sinusitis
21 (.35%)
Liver Disorder
20 (.34%)
Overdose
20 (.34%)
Renal Failure Acute
20 (.34%)
Arthralgia
19 (.32%)
Asthma
19 (.32%)
Constipation
19 (.32%)
Staphylococcal Infection
19 (.32%)
Tremor
19 (.32%)
Anaemia
18 (.3%)
Blood Creatinine Increased
18 (.3%)
Cellulitis
18 (.3%)
Feeling Abnormal
18 (.3%)
Fungal Infection
18 (.3%)
Haemoglobin Decreased
18 (.3%)
Muscular Weakness
18 (.3%)
Back Pain
17 (.28%)
Chills
17 (.28%)
Nasopharyngitis
17 (.28%)
Premature Baby
17 (.28%)
Respiratory Failure
17 (.28%)
Influenza
16 (.27%)
Muscle Spasms
16 (.27%)
Urticaria
16 (.27%)
Atrial Fibrillation
15 (.25%)
Confusional State
15 (.25%)
Dysgeusia
15 (.25%)
Hypertension
15 (.25%)
Insomnia
15 (.25%)
Rhabdomyolysis
15 (.25%)
Thrombocytopenia
15 (.25%)
Abnormal Behaviour
14 (.23%)
Decreased Appetite
14 (.23%)
Weight Increased
14 (.23%)
Adverse Drug Reaction
13 (.22%)
Blood Glucose Increased
13 (.22%)
Dialysis
13 (.22%)
Gait Disturbance
13 (.22%)
Gastric Disorder
13 (.22%)
Hepatic Enzyme Increased
13 (.22%)
Somnolence
13 (.22%)
Tooth Extraction
13 (.22%)
Amnesia
12 (.2%)
Arthritis
12 (.2%)
Blood Alkaline Phosphatase Increase...
12 (.2%)
Blood Pressure Increased
12 (.2%)
Burning Sensation
12 (.2%)
Colitis
12 (.2%)
General Physical Health Deteriorati...
12 (.2%)
Heart Rate Increased
12 (.2%)
Hepatic Failure
12 (.2%)
Localised Infection
12 (.2%)
Musculoskeletal Pain
12 (.2%)
Palpitations
12 (.2%)
Pleural Effusion
12 (.2%)
Stevens-johnson Syndrome
12 (.2%)
Abdominal Discomfort
11 (.18%)
Anorexia
11 (.18%)

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

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

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

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

Drug Use For Unknown Indication
467
Inflammatory Bowel Disease
430
Product Used For Unknown Indication
418
Crohns Disease
233
Infection
151
Prophylaxis
128
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Pneumonia
118
Urinary Tract Infection
114
Antibiotic Prophylaxis
108
Sinusitis
84
Pyrexia
57
Bronchitis
56
Cellulitis
40
Infection Prophylaxis
38
Nasopharyngitis
34
Diarrhoea
33
Cystitis
32
Sepsis
28
Lower Respiratory Tract Infection
26
Staphylococcal Infection
23
Upper Respiratory Tract Infection
21
Ill-defined Disorder
20
Bacterial Infection
19
Acne
18
Febrile Neutropenia
17
Oral Infection
16
Peritonitis
16
Localised Infection
16
Epididymitis
16
Chronic Obstructive Pulmonary Disea...
14
Respiratory Tract Infection
14
Ear Infection
14
Skin Infection
13
Cough
13
Drug Exposure During Pregnancy
12
Antibiotic Therapy
12
Pharyngitis Streptococcal
12
Pharyngitis
12
Rash
11
Kidney Infection
11
Tooth Abscess
11
Osteonecrosis
10
Enterocolitis
10
Diverticulitis
10
Helicobacter Infection
10
Pain
9
Lung Infiltration
9
Pneumonia Aspiration
9
Osteomyelitis
8
Skin Candida
8
Lyme Disease
8

Antibiotics Case Reports

What Antibiotics 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 Antibiotics. 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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