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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.

Postmarketing Experience

In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with Rocephin. Data are generally insufficient to allow an estimate of incidence or to establish causation.

A small number of cases of fatal outcomes in which a crystalline material was observed in the lungs and kidneys at autopsy have been reported in neonates receiving Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin and calcium-containing fluids and in some a precipitate was observed in the intravenous infusion line. At least one fatality has been reported in a neonate in whom Rocephin and calcium-containing fluids were administered at different time points via different intravenous lines; no crystalline material was observed at autopsy in this neonate. There have been no similar reports in patients other than neonates.

GASTROINTESTINAL – stomatitis and glossitis.

GENITOURINARY – oliguria.

DERMATOLOGIC – exanthema, allergic dermatitis, urticaria, edema. As with many medications, isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported.

Cephalosporin Class Adverse Reactions

In addition to the adverse reactions listed above which have been observed in patients treated with ceftriaxone, the following adverse reactions and altered laboratory test results have been reported for cephalosporin class antibiotics:

Adverse Reactions: Allergic reactions, drug fever, serum sickness-like reaction, renal dysfunction, toxic nephropathy, reversible hyperactivity, hypertonia, hepatic dysfunction including cholestasis, aplastic anemia, hemorrhage, and superinfection.

Altered Laboratory Tests: Positive direct Coombs' test, false-positive test for urinary glucose, and elevated LDH.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION). If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.



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: 2013-06-21

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