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Cefepime Side Effects

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Common Cefepime Side Effects


The most commonly reported Cefepime side effects (click to view or check a box to report):

Status Epilepticus (63)
Confusional State (42)
Myoclonus (40)
Pyrexia (33)
Encephalopathy (32)
Rash (31)
Neurotoxicity (26)
Renal Failure Acute (22)
Convulsion (22)
Agitation (21)
Mental Status Changes (21)
Diarrhoea (19)
Aphasia (19)
Death (18)
Renal Failure (17)
Sepsis (17)
Coma (16)
Blood Creatinine Increased (16)
Erythema (13)
Blood Urea Increased (12)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Cefepime Side Effects Reported to FDA



Cefepime Side Effect Report#9914177
Coma, Status Epilepticus, Myoclonus, Cardiac Failure
This is a report of a 60-year-old male patient (weight: NA) from ES, suffering from the following health symptoms/conditions: respiratory tract infection, who was treated with Cefepime (dosage: 3 X 2 G Every 1 Day(s) Intravenous (n, start time: NS), combined with:
  • Tacrolimus
and developed a serious reaction and side effect(s): Coma, Status Epilepticus, Myoclonus, Cardiac Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime treatment in male patients, resulting in Coma side effect.
Cefepime Side Effect Report#9892680
Renal Tubular Necrosis
This report suggests a potential Cefepime Injection Renal Tubular Necrosis side effect(s) that can have serious consequences. A 31-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cellulitis,evidence based treatment and used Cefepime Injection (dosage: NA) starting NS. After starting Cefepime Injection the patient began experiencing various side effects, including: Renal Tubular NecrosisAdditional drugs used concurrently: NA. Although Cefepime Injection demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Renal Tubular Necrosis, may still occur.
Cefepime Side Effect Report#9879771
Speech Disorder, Altered State Of Consciousness, Dysphagia
This Speech Disorder problem was reported by a health professional from JP. A 76-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: infection. On
Nov 27, 2013 this consumer started treatment with Cefepime Hydrochloride Sandoz (dosage: 2 G Per Day). The following drugs were being taken at the same time:
  • Teicoplanin (Unk Ukn, Unk)
  • Nexium//esomeprazole Magnesium
  • Depas
  • Rifadin
  • Argamate
  • Sennoside
  • Vitamedin (Unk Ukn, Unk)
  • Heparin Na Lock
When using Cefepime Hydrochloride Sandoz, the patient experienced the following unwanted symptoms/side effects: Speech Disorder, Altered State Of Consciousness, DysphagiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Speech Disorder, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9870573
Cardiac Failure, Status Epilepticus, Mental Disorder, Disturbance In Attention, Myoclonus, Toxicity To Various Agents, Coma
This Cardiac Failure side effect was reported by a health professional from ES. A 60-year-old male patient (weight:NA) experienced the following symptoms/conditions: pseudomonas infection,respiratory tract infection.The patient was prescribed Cefepime (drug dosage: 2 G, Q8h), which was initiated on NS. Concurrently used drugs: NA..After starting to take Cefepime the consumer reported adverse symptoms, such as: Cardiac Failure, Status Epilepticus, Mental Disorder, Disturbance In Attention, Myoclonus, Toxicity To Various Agents, ComaThese side effects may potentially be related to Cefepime.
Cefepime Side Effect Report#9839235
Fusarium Infection
This is a report of a 42-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Cefepime Injection (dosage: NA, start time: NS), combined with:
  • Vancomycin Injection, Usp
  • Ciprofloxacin
  • Acyclovir
and developed a serious reaction and side effect(s): Fusarium Infection after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime Injection treatment in male patients, resulting in Fusarium Infection side effect.
Cefepime Side Effect Report#9737179
Mouth Ulceration, Skin Exfoliation, Pigmentation Disorder, Skin Lesion, Skin Burning Sensation, Chills, Erythema, Rash
This report suggests a potential Cefepime Hcl Mouth Ulceration side effect(s) that can have serious consequences. A 28-year-old female patient (weight: NA) from IN was diagnosed with the following symptoms/conditions: urinary tract infection,grand mal convulsion and used Cefepime Hcl (dosage: 1 Gm, Unk) starting NS. After starting Cefepime Hcl the patient began experiencing various side effects, including: Mouth Ulceration, Skin Exfoliation, Pigmentation Disorder, Skin Lesion, Skin Burning Sensation, Chills, Erythema, RashAdditional drugs used concurrently:
  • Phenytoin (Loading Dose)
  • Phenytoin (300 Mg At Night)
  • Amikacin (500 Mg, Unk)
  • Ethambutol (800 Mg, Unk)
  • Levetiracetam (500 Mg, 2x/day)
  • Tigecycline (500 Mg, 2x/day)
  • Polymyxins (1 Mu, Unk)
  • Polymyxins
The patient was hospitalized. Although Cefepime Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Mouth Ulceration, may still occur.
Cefepime Side Effect Report#9736489
Stevens-johnson Syndrome, Pyrexia, Pruritus, Rash Erythematous, Mouth Ulceration, Skin Exfoliation, Pigmentation Disorder, Skin Exfoliation, Burning Sensation
This Stevens-johnson Syndrome problem was reported by a health professional from IN. A 28-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: urinary tract infection. On NS this consumer started treatment with Cefepime Hydrochloride (dosage: Infusion). The following drugs were being taken at the same time: NA. When using Cefepime Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Stevens-johnson Syndrome, Pyrexia, Pruritus, Rash Erythematous, Mouth Ulceration, Skin Exfoliation, Pigmentation Disorder, Skin Exfoliation, Burning SensationThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Stevens-johnson Syndrome, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9729055
Delirium, Altered State Of Consciousness, Depressed Level Of Consciousness
This Delirium side effect was reported by a health professional from JP. A 74-year-old male patient (weight:NA) experienced the following symptoms/conditions: post procedural bile leak.The patient was prescribed Cefepime (drug dosage: 4 G, Daily), which was initiated on NS. Concurrently used drugs: NA..After starting to take Cefepime the consumer reported adverse symptoms, such as: Delirium, Altered State Of Consciousness, Depressed Level Of ConsciousnessThese side effects may potentially be related to Cefepime.
Cefepime Side Effect Report#9713782
Convulsion
This is a report of a 80-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: pneumonia, who was treated with Cefepime (dosage: 2 Gm, Once, Iv, start time:
Oct 06, 2013), combined with: NA. and developed a serious reaction and side effect(s): Convulsion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime treatment in male patients, resulting in Convulsion side effect. The patient was hospitalized.
Cefepime Side Effect Report#9697375
Blood Urea Increased, Blood Creatinine Increased
This report suggests a potential Cefepime Blood Urea Increased side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: osteomyelitis and used Cefepime (dosage: NA) starting
Oct 03, 2013. After starting Cefepime the patient began experiencing various side effects, including: Blood Urea Increased, Blood Creatinine IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cefepime demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Urea Increased, may still occur.
Cefepime Side Effect Report#9697355
Pyrexia, Angioedema, Rash
This Pyrexia problem was reported by a pharmacist from US. A 69-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: sepsis. On
Oct 16, 2013 this consumer started treatment with Cefepime (dosage: NA). The following drugs were being taken at the same time: NA. When using Cefepime, the patient experienced the following unwanted symptoms/side effects: Pyrexia, Angioedema, RashThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pyrexia, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9678987
Tubulointerstitial Nephritis, Tubulointerstitial Nephritis, Blood Pressure Systolic Increased, Blood Pressure Increased, Local Swelling, Incision Site Pain, Incision Site Vesicles, Incision Site Haemorrhage, Haemoglobin Decreased
This Tubulointerstitial Nephritis side effect was reported by a physician from US. A 13-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cefepime (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Clindamycin
  • Vancomycin
  • Amoxi-claculanico
  • Gentamicin
  • Itraconazole
.After starting to take Cefepime the consumer reported adverse symptoms, such as: Tubulointerstitial Nephritis, Tubulointerstitial Nephritis, Blood Pressure Systolic Increased, Blood Pressure Increased, Local Swelling, Incision Site Pain, Incision Site Vesicles, Incision Site Haemorrhage, Haemoglobin DecreasedThese side effects may potentially be related to Cefepime.
Cefepime Side Effect Report#9636563
Pyrexia, Erythema, Rash Macular, Pruritus
This is a report of a 53-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: infection, who was treated with Cefepime (dosage: NA, start time: NS), combined with:
  • Vancomycin
and developed a serious reaction and side effect(s): Pyrexia, Erythema, Rash Macular, Pruritus after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime treatment in male patients, resulting in Pyrexia side effect.
Cefepime Side Effect Report#9616183
Convulsion
This report suggests a potential Cefepime Convulsion side effect(s) that can have serious consequences. A 66-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: upper respiratory tract infection and used Cefepime (dosage: Other) starting
Sep 23, 2013. After starting Cefepime the patient began experiencing various side effects, including: ConvulsionAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cefepime demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Convulsion, may still occur.
Cefepime Side Effect Report#9615332
Mental Status Changes, Renal Failure Chronic
This Mental Status Changes problem was reported by a pharmacist from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: mastoiditis. On NS this consumer started treatment with Cefepime (dosage: 2 Gram, Q12h, Picc). The following drugs were being taken at the same time: NA. When using Cefepime, the patient experienced the following unwanted symptoms/side effects: Mental Status Changes, Renal Failure ChronicThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Mental Status Changes, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9575150
Delirium, Dyskinesia, Communication Disorder, Decreased Eye Contact, Hallucination, Altered State Of Consciousness
This Delirium side effect was reported by a health professional from JP. A 70-year-old male patient (weight:NA) experienced the following symptoms/conditions: pneumonia.The patient was prescribed Cefepime Hydrochloride Sandoz (drug dosage: 1 G, Qd), which was initiated on
Feb 12, 2013. Concurrently used drugs:
  • Lasix
  • Insulin
.After starting to take Cefepime Hydrochloride Sandoz the consumer reported adverse symptoms, such as: Delirium, Dyskinesia, Communication Disorder, Decreased Eye Contact, Hallucination, Altered State Of ConsciousnessThese side effects may potentially be related to Cefepime Hydrochloride Sandoz.
Cefepime Side Effect Report#9553261
Diarrhoea, Mucous Membrane Disorder, Nausea, Product Odour Abnormal, Injection Site Pain, Dizziness, Catheter Site Pain, Anorectal Discomfort, Genital Burning Sensation
This is a report of a 52-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteomyelitis,intervertebral discitis, who was treated with Cefepime (dosage: NA, start time:
Sep 12, 2013), combined with: NA. and developed a serious reaction and side effect(s): Diarrhoea, Mucous Membrane Disorder, Nausea, Product Odour Abnormal, Injection Site Pain, Dizziness, Catheter Site Pain, Anorectal Discomfort, Genital Burning Sensation after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime treatment in female patients, resulting in Diarrhoea side effect.
Cefepime Side Effect Report#9518822
Confusional State, Mental Status Changes, Hallucination, Stupor, Myoclonus
This report suggests a potential Cefepime Confusional State side effect(s) that can have serious consequences. A 10-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: infection and used Cefepime (dosage: 2 G Tid Intravenous) starting
Sep 01, 2013. After starting Cefepime the patient began experiencing various side effects, including: Confusional State, Mental Status Changes, Hallucination, Stupor, MyoclonusAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cefepime demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Confusional State, may still occur.
Cefepime Side Effect Report#9496671
Inflammation, Pyrexia
This Inflammation problem was reported by a health professional from JP. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: endocarditis. On NS this consumer started treatment with Cefepime Hydrochloride (dosage: 4 G/day). The following drugs were being taken at the same time:
  • Ceftriaxone Sodium (2 G/day)
  • Gentamicin (80 Mg/day)
  • Vancomycin Hydrochloride (1 G/ Day)
  • Cefazolin Sodium (3 G, Unk)
  • Meropenem (1.5 G/day)
  • Sulbactam-ampicillin
  • Gamma-globulin (5 G/day)
When using Cefepime Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Inflammation, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Inflammation, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9380700
Speech Disorder, Confusional State, Mental Status Changes
This Speech Disorder side effect was reported by a consumer or non-health professional from US. A 88-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Cefepime Injection (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • 0.9% Sodium Chloride Injection
.After starting to take Cefepime Injection the consumer reported adverse symptoms, such as: Speech Disorder, Confusional State, Mental Status ChangesThese side effects may potentially be related to Cefepime Injection.
Cefepime Side Effect Report#9373591
Shock, Face Oedema, Dyspnoea
This is a report of a 41-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: bronchitis, who was treated with Cefepime (dosage: 1 G, Daily Dose, start time:
Jun 10, 2013), combined with: NA. and developed a serious reaction and side effect(s): Shock, Face Oedema, Dyspnoea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime treatment in female patients, resulting in Shock side effect.
Cefepime Side Effect Report#9371605
Rash
This report suggests a potential Cefepime Rash side effect(s) that can have serious consequences. A 64-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cellulitis,gram stain negative and used Cefepime (dosage: 1 Gm Every Day Iv) starting
Jun 05, 2013. After starting Cefepime the patient began experiencing various side effects, including: RashAdditional drugs used concurrently: NA.The patient was hospitalized. Although Cefepime demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Rash, may still occur.
Cefepime Side Effect Report#9365632
Muscle Twitching, Asthenia, Hyponatraemia
This Muscle Twitching problem was reported by a pharmacist from US. A 64-year-old patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
May 29, 2013 this consumer started treatment with Cefepime (dosage: 2g Q12h Iv Bolus). The following drugs were being taken at the same time: NA. When using Cefepime, the patient experienced the following unwanted symptoms/side effects: Muscle Twitching, Asthenia, HyponatraemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Muscle Twitching, may become evident only after a product is in use by the general population.
Cefepime Side Effect Report#9362881
Ocular Hyperaemia, Eye Pruritus, Erythema, Pain, Medical Device Complication, Medical Device Complication
This Ocular Hyperaemia side effect was reported by a health professional from US. A 89-year-old female patient (weight:NA) experienced the following symptoms/conditions: urinary tract infection,culture urine.The patient was prescribed Cefepime (drug dosage: May -} June 5), which was initiated on NS. Concurrently used drugs: NA..After starting to take Cefepime the consumer reported adverse symptoms, such as: Ocular Hyperaemia, Eye Pruritus, Erythema, Pain, Medical Device Complication, Medical Device ComplicationThese side effects may potentially be related to Cefepime.
Cefepime Side Effect Report#9341785
Skin Exfoliation, Pruritus, Erythema, Urticaria
This is a report of a 61-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: arthritis bacterial,hypertension, who was treated with Cefepime Hydrochloride (dosage: NA, start time: NS), combined with:
  • Metoprolol
  • Levofloxacin
  • Tacrolimus
  • Coumadin
  • Docusate Sodium
and developed a serious reaction and side effect(s): Skin Exfoliation, Pruritus, Erythema, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Cefepime Hydrochloride treatment in female patients, resulting in Skin Exfoliation side effect. The patient was hospitalized.


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The appearance of Cefepime on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

What are common Cefepime Side Effects for Women?

Women Side EffectsReports
Status Epilepticus 45
Myoclonus 23
Confusional State 21
Encephalopathy 16
Mental Status Changes 16
Agitation 14
Convulsion 14
Pyrexia 13
Blood Creatinine Increased 11
Rash 11

What are common Cefepime Side Effects for Men?

Men Side EffectsReports
Confusional State 20
Pyrexia 20
Rash 19
Myoclonus 17
Status Epilepticus 17
Encephalopathy 16
Neurotoxicity 15
Renal Failure Acute 14
Aphasia 12
Diarrhoea 10

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Cefepime reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    How Effective is Cefepime for You?

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    Cefepime Safety Alerts, Active Ingredients, Usage Information

    NDC0264-3193
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCEFEPIME HYDROCHLORIDE AND DEXTROSE
    NameCEFEPIME HYDROCHLORIDE
    Dosage FormINJECTION, SOLUTION
    RouteINTRAVENOUS
    On market since20100506
    LabelerB. Braun Medical Inc.
    Active Ingredient(s)CEFEPIME HYDROCHLORIDE
    Strength(s)1
    Unit(s)g/50mL
    Pharma ClassCephalosporin Antibacterial [EPC],Cephalosporins [Chemical/Ingredient]

    More About Cefepime

    Side Effects reported to FDA: 397

    Cefepime safety alerts: 2014 2009 2008 2007

    Reported deaths: 69

    Reported hospitalizations: 165

    Cefepime (marketed as Maxipime) Update of Ongoing Safety Review

    Audience: Infectious disease healthcare professionals

    FDA notified healthcare professionals that it has finished its analysis of a possible risk of higher death with cefepime, an antibiotic, following publication of a study that suggested a higher rate of death in patients treated with this drug, as compared to patients treated with similar drugs. FDA reviewed this study data and conducted additional analyses based on additional data, including data submitted by Bristol Meyers Squibb. FDA has determined that the data do not indicate a higher rate of death in cefepime-treated patients. Cefepime remains an appropriate therapy for its approved indications.

    FDA will continue to review the safety of cefepime. As part of this ongoing review, both FDA and Bristol Meyers Squib are conducting separate analyses of death potentially associated with cefepime, using hospital drug use data. The results of these analyses likely will be reported in approximately one year.

    [06/17/2009 - Information for Healthcare Professionals - FDA]

    Previous MedWatch safety alert:

    November 2007, updated May 2008 - Cefepime (marketed as Maxipime)

    Latest Cefepime clinical trials