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Rocephin (Ceftriaxone) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rocephin (Ceftriaxone) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (446)
Death (72)
Life Threatening Events (53)
Disability (13)

Reports by Reaction Type

Renal Failure Acute (41)Pyrexia (32)Drug Rash With Eosinophilia and Systemic Symptoms (32)Thrombocytopenia (20)Pneumonia (20)Pruritus (19)Sepsis (19)Drug Interaction (18)Confusional State (15)Cytolytic Hepatitis (15)Eosinophilia (15)Renal Failure (15)

Below are a few examples of reports where side effects / adverse reactions may be related to Rocephin (Ceftriaxone). For a complete list or a specific selection of reports, please use the links above.

Possible Rocephin side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-27

Patient: male

Reactions: Sialoadenitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Optiject 300
    Dosage: 90 ml, single
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-20
    End date: 2012-06-20

Primperan TAB
    Dosage: 10 mg, tid
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-20

Rocephin
    Dosage: 1 g, single
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-20

Other drugs received by patient: Acetaminophen; Morphine Sulfate; Zolpidem; Ofloxacin



Possible Rocephin side effects in female

Reported by a physician from France on 2012-08-27

Patient: female

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Administration route: Oral
    Indication: Oral Candidiasis
    Start date: 2011-08-13
    End date: 2011-08-29

Lasix
    Administration route: Oral
    Indication: Hypertension
    Start date: 2011-08-17

Propylthiouracil
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-08-18
    End date: 2011-08-22

Rocephin
    Indication: Bronchitis
    Start date: 2011-08-11
    End date: 2011-08-22

Rovamycine
    Indication: Bronchitis
    Start date: 2011-08-11

Roxithromycine
    Administration route: Oral
    Indication: Bronchitis
    Start date: 2011-08-16
    End date: 2011-08-23

Other drugs received by patient: Potassium Chloride; Potassium Chloride; Transipeg (France)



Possible Rocephin side effects in 65 year old female

Reported by a pharmacist from Switzerland on 2012-08-24

Patient: 65 year old female, weighing 55.3 kg (121.7 pounds)

Reactions: Vomiting, Pruritus, Chills, Pyrexia, Drug Rash With Eosinophilia and Systemic Symptoms, Eosinophilia, Hepatic Enzyme Increased, C-Reactive Protein Increased, Oedema Peripheral, Rash Erythematous, Lymphocyte Morphology Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-01
    End date: 2012-05-25

Keppra
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metronidazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-26
    End date: 2012-05-25

Pantoprazole
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-01
    End date: 2012-05-25

Rocephin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-04-26
    End date: 2012-05-21

Other drugs received by patient: Calcium Carbonate; Clindamycin HCL; Amoxicillin; Konakion; Meropenem; Prednisone TAB; Clemastine Fumarate



Possible Rocephin side effects in 1 year old

Reported by a physician from Japan on 2012-08-24

Patient: 1 year old

Reactions: Ileus

Drug(s) suspected as cause:
Rocephin



Possible Rocephin side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: male

Reactions: Intestinal Ischaemia, Abdominal Pain, Abdominal Distension, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Arixtra
    Start date: 2012-01-27
    End date: 2012-03-01

Atarax
    Dosage: evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Chlorpromazine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27

Codeine
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Flagyl
    Indication: Product Used FOR Unknown Indication

Imodium
    Start date: 2012-02-02

Imodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Nexium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Quetiapine Fumarate
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-02-06

Quetiapine Fumarate
    Administration route: Oral
    Start date: 2012-03-06

Rocephin
    Indication: Product Used FOR Unknown Indication

Sandostatin
    Dosage: 1 in the morning and 1 in the evening
    Start date: 2012-03-01
    End date: 2012-03-01

Sandostatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Spasfon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Tranxene
    Dosage: in the evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Tranxene
    Start date: 2012-01-27
    End date: 2012-03-01



Possible Rocephin side effects in male

Reported by a physician from Japan on 2012-08-23

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Drug Eruption, Renal Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Risperdal; Rohypnol; Carbamazepine; Donepezil HCL



Possible Rocephin side effects in 65 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient: 65 year old female

Reactions: Drug Resistance, Deafness

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Ampicillin
    Indication: Meningitis Pneumococcal

Rocephin
    Indication: Meningitis Pneumococcal

Vancomycin
    Indication: Meningitis Pneumococcal



Possible Rocephin side effects in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient: 45 year old male

Reactions: Drug Resistance

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Vancomycin



Possible Rocephin side effects in 68 year old female

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient: 68 year old female

Reactions: Drug Resistance

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Ampicillin; Vancomycin



Possible Rocephin side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-22

Patient:

Reactions: Enterococcal Bacteraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocephin



Possible Rocephin side effects in 50 year old male

Reported by a health professional (non-physician/pharmacist) from Korea, Republic of on 2012-08-22

Patient: 50 year old male

Reactions: Drug Resistance

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Vancomycin



Possible Rocephin side effects in

Reported by a pharmacist from Taiwan, Province of China on 2012-08-21

Patient:

Reactions: Hepatotoxicity

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Vancomycin; Penicillin G



Possible Rocephin side effects in 66 year old male

Reported by a physician from France on 2012-08-21

Patient: 66 year old male

Reactions: Cardio-Respiratory Arrest, Anaphylactic Shock

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Amikacin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-02

Rocephin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-07-02

Other drugs received by patient: Vancomycin; Clamoxyl (France); Tazobactam; Gentamicin



Possible Rocephin side effects in male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: male

Reactions: Abdominal Pain, Intestinal Ischaemia, Abdominal Distension, Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen
    Indication: Product Used FOR Unknown Indication

Acetaminophen
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Arixtra
    Start date: 2012-03-06
    End date: 2012-03-01

Arixtra
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27
    End date: 2012-03-01

Atarax
    Dosage: evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Chlorpromazine HCL
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-01-27

Codeine
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Flagyl
    Indication: Product Used FOR Unknown Indication

Imodium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06
    End date: 2012-03-01

Imodium
    Start date: 2012-02-02

Nexium
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Quetiapine Fumarate
    Administration route: Oral
    Start date: 2012-02-06

Quetiapine Fumarate
    Administration route: Oral
    Indication: Schizophrenia
    Start date: 2012-03-06

Rocephin
    Indication: Product Used FOR Unknown Indication

Sandostatin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-01
    End date: 2012-03-01

Sandostatin
    Dosage: 1 in the morning and 1 in the evening
    Start date: 2012-03-01
    End date: 2012-03-01

Spasfon
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-02-02

Tranxene
    Dosage: in the evening
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-03-06

Tranxene
    Start date: 2012-01-27
    End date: 2012-03-01



Possible Rocephin side effects in 89 year old female

Reported by a physician from France on 2012-08-20

Patient: 89 year old female

Reactions: Cytolytic Hepatitis, Ocular Icterus, Pyrexia

Adverse event resulted in: death

Drug(s) suspected as cause:
Cymbalta
    Administration route: Oral
    Indication: Anxiety
    Start date: 2012-06-26
    End date: 2012-06-29

Folic Acid
    Administration route: Oral
    Indication: Folate Deficiency
    Start date: 2012-06-19
    End date: 2012-06-29

Lovenox
    Indication: Prophylaxis
    Start date: 2012-06-18
    End date: 2012-06-30

Oxycodone Hydrochloride
    Administration route: Oral
    Indication: Abdominal Pain
    Start date: 2012-06-18
    End date: 2012-06-29

Rocephin
    Indication: Cardiac Failure

Rocephin
    Indication: Lung Infection
    Start date: 2012-06-18
    End date: 2012-06-29

Other drugs received by patient: Nexium; Gaviscon (France); Tramadol HCL; Alprazolam; Acetaminophen; Aspirin; Transipeg (France); Furosemide; Calcium Carbonate; Potassium Chloride



Possible Rocephin side effects in female

Reported by a physician from France on 2012-08-20

Patient: female

Reactions: Dysaesthesia, Paraesthesia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Flagyl
    Administration route: Oral
    Indication: Mastoiditis
    Start date: 2012-06-19
    End date: 2012-07-26

Ofloxacin
    Dosage: auricular drops 1.5mg/0.5ml
    Administration route: Oral
    Indication: Mastoiditis
    Start date: 2012-06-19

Rocephin
    Indication: Mastoiditis
    Start date: 2012-06-19

Other drugs received by patient: Antalgic; Previscan



Possible Rocephin side effects in 53 year old female

Reported by a physician from Germany on 2012-08-17

Patient: 53 year old female

Reactions: Ageusia, Anosmia

Drug(s) suspected as cause:
Keppra
    Administration route: Oral
    Indication: Epilepsy
    Start date: 2012-03-15

Rocephin
    Indication: Lyme Disease
    Start date: 2012-04-22
    End date: 2012-05-06

Other drugs received by patient: Propranolol HCL



Possible Rocephin side effects in male

Reported by a physician from Japan on 2012-08-17

Patient: male

Reactions: Shock

Drug(s) suspected as cause:
Rocephin
    Start date: 2012-06-26
    End date: 2012-06-28

Rocephin
    Start date: 2012-06-18
    End date: 2012-06-23

Rocephin
    Start date: 2012-06-30
    End date: 2012-06-30

Rocephin
    Indication: Pneumonia
    Start date: 2012-06-14
    End date: 2012-06-16

Rocephin
    Start date: 2012-07-02
    End date: 2012-07-02

Other drugs received by patient: Levofloxacin; Levofloxacin; Mucosolvan L; Loxonin; Garenoxacin Mesylate



Possible Rocephin side effects in 58 year old male

Reported by a physician from France on 2012-08-16

Patient: 58 year old male

Reactions: Sialoadenitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ioversol
    Dosage: 300mg dl/ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-20
    End date: 2012-06-20

Primperan Elixir
    Dosage: 10mg/2ml
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-20

Rocephin
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-17
    End date: 2012-06-20

Other drugs received by patient: Transipeg (France); Actiskenan (Morphine Chlorhydrate); Ofloxacin; Acetaminophen; Normacol (France); Skenan LP; Zolpidem Tartrate



Possible Rocephin side effects in female

Reported by a physician from France on 2012-08-15

Patient: female

Reactions: Anaemia, Drug Interaction, Haematoma, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient possibly interacting with the suspect drug:
Previscan (France)
    Dosage: restarted

Previscan (France)
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    End date: 2011-01-07

Other drugs received by patient: Escitalopram; Lasix; Depakene; Dicetel; Potassium Chloride



Possible Rocephin side effects in 88 year old female

Reported by a physician from France on 2012-08-14

Patient: 88 year old female

Reactions: Linear IGA Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocephin



Possible Rocephin side effects in 65 year old male

Reported by a physician from France on 2012-08-13

Patient: 65 year old male

Reactions: Pancytopenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Augmentin '500'
    Administration route: Oral
    Indication: Arthritis Bacterial
    Start date: 2012-06-21
    End date: 2012-06-26

Colchicine
    Administration route: Oral
    Indication: Arthritis Bacterial
    Start date: 2012-06-26
    End date: 2012-06-28

Rocephin
    Indication: Arthritis Bacterial
    Start date: 2012-06-26
    End date: 2012-06-28

Other drugs received by patient: Bisoprolol Fumarate; Enalapril Maleate



Possible Rocephin side effects in

Reported by a physician from Japan on 2012-08-13

Patient:

Reactions: Haemoglobin Decreased, Pyelonephritis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
PEG-Intron
    Dosage: 1.5mcg/kg/week
    Indication: Hepatitis C
    Start date: 2012-04-11

PEG-Intron
    Dosage: 1.5mcg/kg/week
    Start date: 2012-06-13

PEG-Intron
    Dosage: 1.5mcg/kg/week
    Start date: 2012-05-30
    End date: 2012-06-05

Rebetol
    Administration route: Oral
    Start date: 2012-06-27

Rebetol
    Administration route: Oral
    Start date: 2012-05-23

Rebetol
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-11
    End date: 2012-05-22

Rebetol
    Administration route: Oral
    Start date: 2012-05-30
    End date: 2012-06-05

Rebetol
    Administration route: Oral
    Start date: 2012-06-06
    End date: 2012-06-26

Rocephin
    Indication: Adverse Event
    Start date: 2012-05-29
    End date: 2012-06-04

Telavic
    Administration route: Oral
    Start date: 2012-06-13

Telavic
    Administration route: Oral
    Start date: 2012-05-30
    End date: 2012-06-05

Telavic
    Administration route: Oral
    Indication: Hepatitis C
    Start date: 2012-04-11

Other drugs received by patient: Norvasc; Candesartan Cilexetil; Allegra



Possible Rocephin side effects in female

Reported by a physician from Japan on 2012-08-13

Patient: female, weighing 55.0 kg (121.0 pounds)

Reactions: Cardio-Respiratory Arrest, Shock

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Rocephin
    Start date: 2012-07-24
    End date: 2012-07-24

Rocephin
    Indication: Cystitis
    Start date: 2012-07-06
    End date: 2012-07-07



Possible Rocephin side effects in

Reported by a physician from United States on 2012-08-10

Patient:

Reactions: Pruritus, Dyspnoea, Nausea, Erythema, Cardiac Failure Congestive

Drug(s) suspected as cause:
Actos
    Indication: Product Used FOR Unknown Indication

Blockain
    Indication: Product Used FOR Unknown Indication

Excedrin (United States)
    Indication: Product Used FOR Unknown Indication

Levaquin
    Indication: Product Used FOR Unknown Indication

Rocephin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lipitor; Spiriva; Niacin; Aspirin; Narcotics; Fish OIL; Albuterol; Fluticasone Propionate; Dimexid; Calcium D3; Levothyroxine Sodium; Aldactone; Glipizide; Potassium Chloride; Fosamax; Zantac; Ativan



Possible Rocephin side effects in male

Reported by a physician from Japan on 2012-08-09

Patient: male, weighing 52.0 kg (114.4 pounds)

Reactions: Drug Eruption, Renal Disorder

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Rocephin



Possible Rocephin side effects in female

Reported by a physician from France on 2012-08-09

Patient: female

Reactions: Drug Eruption

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Pantoprazole Sodium; Gaviscon (France); Acetaminophen; Econazole



Possible Rocephin side effects in female

Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-08-09

Patient: female

Reactions: Enterocolitis Haemorrhagic, Gastrointestinal Haemorrhage, Anaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clarithromycin
    Dosage: 1000 mg
    Administration route: Oral
    Indication: Pneumonia
    Start date: 2012-03-23
    End date: 2012-04-05

Escitalopram
    Dosage: 10 mg
    Administration route: Oral

Fragmin
    Dosage: 5000 iu
    Indication: Prophylaxis
    Start date: 2012-03-01
    End date: 2012-04-04

Ibruprofen
    Administration route: Oral
    Indication: Back Pain
    Start date: 2012-03-01
    End date: 2012-04-04

Methotrexate
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2005-08-01
    End date: 2012-04-04

Prednisone TAB
    Dosage: 10 mg
    Administration route: Oral
    Indication: Psoriasis
    Start date: 2005-08-01

Rocephin
    Dosage: 2 g
    Indication: Pneumonia
    Start date: 2012-03-23
    End date: 2012-04-05

Other drugs received by patient: Pantoprazole; Calcimagon D3; Ramipril



Possible Rocephin side effects in male

Reported by a pharmacist from Japan on 2012-08-09

Patient: male, weighing 59.0 kg (129.8 pounds)

Reactions: Cholelithiasis, Cholecystitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Rocephin

Other drugs received by patient: Aldactone; Lasix; Artist; Gramalil; Enalapril Maleate; Kalimate



Possible Rocephin side effects in male

Reported by a pharmacist from Japan on 2012-08-08

Patient: male, weighing 63.0 kg (138.6 pounds)

Reactions: International Normalised Ratio Increased, Haematuria, Drug Interaction, Epistaxis, Pyelonephritis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Garenoxacin Mesylate
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-05-15
    End date: 2012-05-21

Loxonin
    Administration route: Oral
    Start date: 2012-05-15
    End date: 2012-05-21

Loxonin
    Administration route: Oral
    Indication: Analgesic Therapy
    Start date: 2012-05-10
    End date: 2012-05-14

Miconazole
    Dosage: 2%
    Indication: Laryngitis Fungal
    Start date: 2012-05-10
    End date: 2012-05-19

Miconazole

Rabeprazole Sodium
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2012-05-11

Rocephin
    Indication: Laryngitis
    Start date: 2012-05-10
    End date: 2012-05-15

Selbex
    Administration route: Oral
    Start date: 2012-05-15
    End date: 2012-05-21

Selbex
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2012-05-10
    End date: 2012-05-14

Other drugs received by patient possibly interacting with the suspect drug:
Warfarin Sodium
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2012-06-04

Warfarin Sodium
    Administration route: Oral

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