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Rocephin (Ceftriaxone Sodium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Rocephin is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Rocephin therapy or of uncertain etiology, were observed:

LOCAL REACTIONS —pain, induration and tenderness was 1% overall. Phlebitis was reported in <1% after IV administration. The incidence of warmth, tightness or induration was 17% (3/17) after IM administration of 350 mg/mL and 5% (1/20) after IM administration of 250 mg/mL.

HYPERSENSITIVITY —rash (1.7%). Less frequently reported (<1%) were pruritus, fever or chills.

HEMATOLOGIC —eosinophilia (6%), thrombocytosis (5.1%) and leukopenia (2.1%). Less frequently reported (<1%) were anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia and prolongation of the prothrombin time.

GASTROINTESTINAL —diarrhea (2.7%). Less frequently reported (<1%) were nausea or vomiting, and dysgeusia. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS).

HEPATIC —elevations of SGOT (3.1%) or SGPT (3.3%). Less frequently reported (<1%) were elevations of alkaline phosphatase and bilirubin.

RENAL —elevations of the BUN (1.2%). Less frequently reported (<1%) were elevations of creatinine and the presence of casts in the urine.

CENTRAL NERVOUS SYSTEM —headache or dizziness were reported occasionally (<1%).

GENITOURINARY —moniliasis or vaginitis were reported occasionally (<1%).

MISCELLANEOUS —diaphoresis and flushing were reported occasionally (<1%).

Other rarely observed adverse reactions (<0.1%) include abdominal pain, agranulocytosis, allergic pneumonitis, anaphylaxis, basophilia, biliary lithiasis, bronchospasm, colitis, dyspepsia, epistaxis, flatulence, gallbladder sludge, glycosuria, hematuria, jaundice, leukocytosis, lymphocytosis, monocytosis, nephrolithiasis, palpitations, a decrease in the prothrombin time, renal precipitations, seizures, and serum sickness.

Cases of fatal reactions with ceftriaxone-calcium precipitates in lung and kidneys in neonates have been described. In some cases the infusion lines and times of administration of ceftriaxone and calcium-containing solutions differed (see CONTRAINDICATIONS).



REPORTS OF SUSPECTED ROCEPHIN SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Rocephin. The information is not vetted and should not be considered as verified clinical evidence.

Possible Rocephin side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-07

Patient: 56 year old female

Reactions: Toxic Epidermal Necrolysis, Liver Disorder

Adverse event resulted in: death, life threatening event, hospitalization

Suspect drug(s):
Voltaren
    Dosage: 25 mg, 1x/day
    Indication: Antipyresis
    Start date: 2009-05-01
    End date: 2009-05-01

Levofloxacin
    Dosage: 100 mg, 3x/day
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2009-04-27

Banan
    Dosage: 100 mg, 2x/day
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2009-04-25

Voltaren
    Dosage: 25 mg, 1x/day
    Start date: 2009-05-03
    End date: 2009-05-03

Metilon
    Indication: Antipyresis

Voltaren
    Dosage: 12.5 mg, 1x/day
    Start date: 2009-05-07
    End date: 2009-05-07

Metilon
    Dosage: 1 df, 1x/day
    Indication: Pyelonephritis
    Start date: 2009-05-01
    End date: 2009-05-01

Rocephin
    Dosage: 1 g, 1x/day
    Indication: Pyelonephritis
    Start date: 2009-04-29
    End date: 2009-05-10

Voltaren
    Dosage: 12.5 mg, 1x/day
    Start date: 2009-05-06
    End date: 2009-05-06

Voltaren
    Dosage: 12.5 mg, 1x/day
    Start date: 2009-05-10
    End date: 2009-05-10

Other drugs received by patient: Maoto; Tranexamic Acid; Acetaminophen; Betamethasone; Biofermin; Carnaculin; Acetaminophen; Potassium Chloride



Possible Rocephin side effects / adverse reactions in 21 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-13

Patient: 21 year old male

Reactions: Drug Interaction, Ear Infection, Status Epilepticus, Anticonvulsant Drug Level Below Therapeutic

Adverse event resulted in: hospitalization

Suspect drug(s):
Rocephin
    Dosage: parenteral
    Indication: Ear Infection
    Start date: 2011-09-22
    End date: 2011-09-26

Jantoven
    Dosage: 2.5 mg, qd-bid, oral
    Administration route: Oral
    Indication: Deep Vein Thrombosis
    Start date: 2011-09-01
    End date: 2011-09-25

Dilantin
    Dosage: oral
    Administration route: Oral
    Indication: Epilepsy



Possible Rocephin side effects / adverse reactions in 67 year old female

Reported by a physician from France on 2011-10-14

Patient: 67 year old female

Reactions: Myositis, Pyrexia, Inflammation

Adverse event resulted in: hospitalization

Suspect drug(s):
Rocephin
    Indication: Cholecystitis
    Start date: 2011-09-04
    End date: 2011-09-12

Rocephin
    Indication: Pyelonephritis



See index of all Rocephin side effect reports >>

Drug label data at the top of this Page last updated: 2008-01-29

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