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PENICILLIN

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Penicillin Adverse Events Reported to the FDA Over Time

How are Penicillin adverse event reports trending over time?

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

Most Common Penicillin Adverse Events Reported to the FDA

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

Drug Hypersensitivity
846 (12.2%)
No Adverse Event
167 (2.41%)
Rash
164 (2.36%)
Hypersensitivity
129 (1.86%)
Pyrexia
111 (1.6%)
Urticaria
82 (1.18%)
Nausea
73 (1.05%)
Dyspnoea
68 (.98%)
Vomiting
63 (.91%)
Pruritus
54 (.78%)
Toxic Epidermal Necrolysis
54 (.78%)
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Headache
51 (.74%)
Convulsion
47 (.68%)
Diarrhoea
46 (.66%)
Stevens-johnson Syndrome
44 (.63%)
Injection Site Pain
43 (.62%)
Drug Ineffective
42 (.61%)
Malaise
42 (.61%)
Rash Maculo-papular
39 (.56%)
Anaphylactic Reaction
37 (.53%)
Erythema
37 (.53%)
Arthralgia
36 (.52%)
Fatigue
36 (.52%)
Alanine Aminotransferase Increased
35 (.5%)
Asthenia
35 (.5%)
Dizziness
35 (.5%)
Oedema Peripheral
32 (.46%)
Confusional State
31 (.45%)
Medication Error
29 (.42%)
Pain
29 (.42%)
Pain In Extremity
29 (.42%)
Swelling Face
29 (.42%)
Renal Failure Acute
27 (.39%)
Weight Decreased
27 (.39%)
Leukocytosis
26 (.37%)
Rash Erythematous
26 (.37%)
Heart Rate Increased
25 (.36%)
Feeling Abnormal
23 (.33%)
Muscular Weakness
23 (.33%)
Restlessness
23 (.33%)
Swelling
23 (.33%)
Abdominal Pain Upper
22 (.32%)
Aspartate Aminotransferase Increase...
22 (.32%)
Blood Alkaline Phosphatase Increase...
22 (.32%)
Death
22 (.32%)
Injection Site Erythema
22 (.32%)
Pharyngeal Oedema
22 (.32%)
Thrombocytopenia
22 (.32%)
Expired Drug Administered
21 (.3%)
Skin Exfoliation
21 (.3%)
Abdominal Pain
20 (.29%)
Decreased Appetite
20 (.29%)
Hypotension
20 (.29%)
Chromaturia
19 (.27%)
Drug Exposure During Pregnancy
19 (.27%)
Drug Rash With Eosinophilia And Sys...
19 (.27%)
Jaundice
19 (.27%)
Lymphadenopathy
19 (.27%)
Acute Generalised Exanthematous Pus...
18 (.26%)
Anxiety
18 (.26%)
Blood Creatinine Increased
18 (.26%)
Depression
18 (.26%)
Disturbance In Attention
18 (.26%)
Gamma-glutamyltransferase Increased
18 (.26%)
Tremor
18 (.26%)
Tunnel Vision
18 (.26%)
Blister
17 (.25%)
Chest Pain
17 (.25%)
Drug Interaction
17 (.25%)
Epistaxis
17 (.25%)
Hypoaesthesia
17 (.25%)
Myalgia
17 (.25%)
Oropharyngeal Pain
17 (.25%)
Pancytopenia
17 (.25%)
Sleep Disorder
17 (.25%)
Colitis
16 (.23%)
Dysphagia
16 (.23%)
Lymphopenia
16 (.23%)
Pallor
16 (.23%)
Renal Failure
16 (.23%)
Anaphylactic Shock
15 (.22%)
Candidiasis
15 (.22%)
Cough
15 (.22%)
Hyperchlorhydria
15 (.22%)
Infection
15 (.22%)
Injection Site Swelling
15 (.22%)
Musculoskeletal Discomfort
15 (.22%)
Oedema
15 (.22%)
Wrong Drug Administered
15 (.22%)
Blood Bilirubin Increased
14 (.2%)
Cardio-respiratory Arrest
14 (.2%)
Disorientation
14 (.2%)
Eosinophilia
14 (.2%)
Neutropenia
14 (.2%)
Rash Generalised
14 (.2%)
Sensory Disturbance
14 (.2%)
Septic Shock
14 (.2%)
Stress
14 (.2%)
Cardiac Arrest
13 (.19%)
Chills
13 (.19%)
Face Oedema
13 (.19%)

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

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

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

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

Product Used For Unknown Indication
180
Prophylaxis
109
Drug Use For Unknown Indication
107
Tonsillitis
66
Pharyngitis Streptococcal
65
Lyme Disease
63
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Syphilis
55
Pneumonia
50
Infection
48
Infection Prophylaxis
45
Splenectomy
42
Erysipelas
38
Streptococcal Infection
37
Tooth Infection
36
Pharyngitis
33
Upper Respiratory Tract Infection
29
Bronchitis
24
Endocarditis
22
Antibiotic Therapy
19
Cellulitis
19
Ill-defined Disorder
19
Rheumatic Fever
18
Antibiotic Prophylaxis
18
Sinusitis
17
Tooth Extraction
17
Pyrexia
17
Tooth Abscess
16
Febrile Neutropenia
15
Sepsis
14
Respiratory Tract Infection
12
Bacterial Infection
11
Nasopharyngitis
11
Sickle Cell Anaemia
10
Toothache
10
Anti-infective Therapy
9
Abscess
8
Acute Tonsillitis
8
Rash
7
Pain
7
Tetanus
6
Neurosyphilis
6
Tooth Disorder
6
Gingival Infection
5
Urinary Tract Infection
5
Oral Surgery
5
Pneumococcal Infection
5
Bronchitis Chronic
5
Osteomyelitis
5
Oropharyngeal Pain
4
Rheumatic Heart Disease
4
Pharyngolaryngeal Pain
4

Drug Labels

LabelLabelerEffective
Penicillin V PotassiumRebel Distributors Corp10-NOV-10
Penicillin V PotassiumNorthStar Rx LLC27-JAN-11
Penicillin V PotassiumRebel Distributors Corp09-FEB-11
PfizerpenRoerig25-APR-11
PfizerpenRoerig25-APR-11
Penicillin V PotassiumGolden State Medical Supply, Inc.01-JUL-11
Penicillin V PotassiumGreenstone LLC12-JUL-11
Penicillin G ProcaineKing Pharmaceuticals, Inc.19-JUL-11
Penicillin V PotassiumPD-Rx Pharmaceuticals, Inc.21-OCT-11
Penicillin V PotassiumSandoz Inc21-OCT-11
Penicillin V PotassiumPD-Rx Pharmaceuticals, Inc.21-OCT-11
Penicillin G SodiumSandoz Inc21-OCT-11
Penicillin V PotassiumPhysicians Total Care, Inc.15-FEB-12
Penicillin V PotassiumPreferred Pharmaceuticals, Inc14-MAR-12
Penicillin V PotassiumPreferred Pharmaceuticals, Inc29-MAR-12
Penicillin G PotassiumBaxter Healthcare Corporation06-APR-12
Penicillin V Potassium PD-Rx Pharmaceuticals, Inc.26-APR-12
Penicillin V PotassiumDAVA Pharmaceuticals, Inc.26-APR-12
Penicillin V Potassium PD-Rx Pharmaceuticals, Inc.26-APR-12
Bicillin CrPhysicians Total Care, Inc.21-MAY-12
Bicillin L-aPhysicians Total Care, Inc.21-MAY-12
Penicillin V PotassiumPhysicians Total Care, Inc.20-JUN-12
Penicillin G PotassiumSandoz Inc27-JUN-12
Penicillin G PotassiumAPP Pharmaceuticals, LLC20-SEP-12
Penicillin V PotassiumAurobindo Pharma Limited27-NOV-12
Penicillin V PotassiumTeva Pharmaceuticals USA Inc05-DEC-12
Bicillin L-aKing Pharmaceuticals, Inc.20-DEC-12
Bicillin C-r 900/300King Pharmaceuticals, Inc.20-DEC-12
Bicillin CrKing Pharmaceuticals, Inc.20-DEC-12

Penicillin Case Reports

What Penicillin 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 Penicillin. 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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