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Keflex Adverse Events Reported to the FDA Over Time

How are Keflex adverse event reports trending over time?

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

Most Common Keflex Adverse Events Reported to the FDA

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

Rash
117 (1.76%)
Diarrhoea
115 (1.73%)
Pyrexia
100 (1.5%)
Drug Hypersensitivity
93 (1.4%)
Drug Interaction
91 (1.37%)
Nausea
91 (1.37%)
Vomiting
91 (1.37%)
Dyspnoea
83 (1.25%)
Pruritus
83 (1.25%)
Urticaria
76 (1.14%)
Abdominal Pain
68 (1.02%)
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Pain
63 (.95%)
International Normalised Ratio Incr...
62 (.93%)
Dizziness
58 (.87%)
Malaise
56 (.84%)
Arthralgia
55 (.83%)
Drug Ineffective
55 (.83%)
Headache
55 (.83%)
White Blood Cell Count Increased
47 (.71%)
Deep Vein Thrombosis
46 (.69%)
Stevens-johnson Syndrome
46 (.69%)
Haemoglobin Decreased
45 (.68%)
Pain In Extremity
43 (.65%)
Hypovolaemic Shock
42 (.63%)
Retroperitoneal Haematoma
42 (.63%)
Fatigue
41 (.62%)
Renal Failure Acute
41 (.62%)
Abdominal Pain Upper
38 (.57%)
Hypersensitivity
38 (.57%)
Ureteric Obstruction
38 (.57%)
Urinary Tract Infection
38 (.57%)
Drug Exposure During Pregnancy
36 (.54%)
Anaemia
33 (.5%)
Chest Pain
33 (.5%)
Erythema
33 (.5%)
Completed Suicide
32 (.48%)
Dehydration
32 (.48%)
Muscle Haemorrhage
32 (.48%)
Oedema Peripheral
31 (.47%)
Medication Error
28 (.42%)
Anaphylactic Reaction
27 (.41%)
Rash Pruritic
27 (.41%)
Cellulitis
26 (.39%)
Myalgia
26 (.39%)
Rash Erythematous
26 (.39%)
Rash Generalised
26 (.39%)
Blister
25 (.38%)
Hypotension
25 (.38%)
Swelling Face
25 (.38%)
Condition Aggravated
24 (.36%)
Skin Exfoliation
24 (.36%)
Asthenia
23 (.35%)
Hyponatraemia
23 (.35%)
Muscle Spasms
23 (.35%)
Chills
22 (.33%)
Loss Of Consciousness
22 (.33%)
Paraesthesia
22 (.33%)
Swollen Tongue
22 (.33%)
Decreased Appetite
21 (.32%)
Liver Disorder
21 (.32%)
Liver Function Test Abnormal
21 (.32%)
Weight Decreased
21 (.32%)
Clostridium Difficile Colitis
20 (.3%)
Constipation
20 (.3%)
Tremor
20 (.3%)
Blood Pressure Increased
19 (.29%)
Convulsion
19 (.29%)
Muscular Weakness
19 (.29%)
Pruritus Generalised
19 (.29%)
Staphylococcal Infection
19 (.29%)
Alanine Aminotransferase Increased
18 (.27%)
Heart Rate Increased
18 (.27%)
Clostridial Infection
17 (.26%)
Erythema Multiforme
17 (.26%)
Insomnia
17 (.26%)
Toxic Epidermal Necrolysis
17 (.26%)
Acute Generalised Exanthematous Pus...
16 (.24%)
Cough
16 (.24%)
Cystitis
16 (.24%)
Extrasystoles
16 (.24%)
Haematuria
16 (.24%)
Infection
16 (.24%)
Sinusitis
16 (.24%)
Swelling
16 (.24%)
Fall
15 (.23%)
Feeling Abnormal
15 (.23%)
Hip Fracture
15 (.23%)
Rash Macular
15 (.23%)
Rhabdomyolysis
15 (.23%)
Somnolence
15 (.23%)
Angioedema
14 (.21%)
Apnoea
14 (.21%)
Chest Discomfort
14 (.21%)
Confusional State
14 (.21%)
Drug Dispensing Error
14 (.21%)
Dysphagia
14 (.21%)
Dysuria
14 (.21%)
Rash Papular
14 (.21%)
Anxiety
13 (.2%)
Blood Creatinine Increased
13 (.2%)
Cardiac Arrest
13 (.2%)

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

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

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

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

Urinary Tract Infection
313
Drug Use For Unknown Indication
311
Infection
215
Product Used For Unknown Indication
207
Cellulitis
148
Prophylaxis
70
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Antibiotic Therapy
56
Acne
55
Sinusitis
54
Infection Prophylaxis
43
Bronchitis
41
Localised Infection
37
Antibiotic Prophylaxis
36
Cystitis
32
Bacterial Infection
31
Skin Infection
30
Wound Infection
29
Lower Respiratory Tract Infection
24
Folliculitis
22
Abscess
22
Upper Respiratory Tract Infection
21
Prophylaxis Urinary Tract Infection
19
Toothache
18
Acne Cystic
17
Staphylococcal Infection
17
Furuncle
17
Pharyngitis
17
Pharyngitis Streptococcal
16
Premature Rupture Of Membranes
14
Streptococcal Infection
14
Tooth Infection
13
Subcutaneous Abscess
13
Cough
13
Ear Infection
13
Urethritis
12
Lung Infection
12
Kidney Infection
11
Nasopharyngitis
11
Arthropod Bite
11
Ingrowing Nail
11
Otitis Media
10
Respiratory Tract Infection
10
Neurogenic Bladder
10
Antibacterial Prophylaxis
10
Paronychia
9
Ill-defined Disorder
9
Pneumonia
8
Rash
8
Influenza Like Illness
8
Oral Disorder
8
Wound
8

Drug Labels

LabelLabelerEffective
KeflexVictory Pharma, Inc. 15-DEC-10
KeflexShionogi Inc.22-FEB-12

Keflex Case Reports

What Keflex 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 Keflex. 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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