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 SIDE EFFECTS / ADVERSE REACTIONS RELATED TO ROCEPHIN

Possible Rocephin side effects / adverse reactions in 4 year old male

Reported by a consumer/non-health professional from Italy on 2007-01-05

Patient: 4 year old male

Reactions: Urticaria Generalised, Urticaria

Adverse event resulted in: hospitalization

Suspect drug(s):
Rocephin

Possible Rocephin side effects / adverse reactions in 54 year old male

Reported by a consumer/non-health professional from United Kingdom on 2007-01-09

Patient: 54 year old male

Reactions: Toxic Epidermal Necrolysis

Suspect drug(s):
Rocephin
    Indication: Drug USE FOR Unknown Indication

Actrapid
    Indication: Drug USE FOR Unknown Indication

Vitamin K
    Indication: Drug USE FOR Unknown Indication

Tinzaparin
    Indication: Drug USE FOR Unknown Indication

Thiamin
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Sodium Chloride
    Indication: Drug USE FOR Unknown Indication

Sodium Bicarbonate
    Indication: Drug USE FOR Unknown Indication

Simvastatin
    Indication: Drug USE FOR Unknown Indication

Silver Sulphadiazine
    Administration route: Topical
    Indication: Drug USE FOR Unknown Indication

Sando-K
    Indication: Drug USE FOR Unknown Indication

Ventolin
    Indication: Drug USE FOR Unknown Indication

Propofol
    Indication: Drug USE FOR Unknown Indication

Potassium Phosphates
    Indication: Drug USE FOR Unknown Indication

Potassium Chloride
    Indication: Drug USE FOR Unknown Indication

Piriton
    Indication: Drug USE FOR Unknown Indication

Acetaminophen
    Indication: Drug USE FOR Unknown Indication

Omeprazole
    Indication: Drug USE FOR Unknown Indication

Noradrenaline
    Indication: Drug USE FOR Unknown Indication

Magnesium Sulfate
    Indication: Drug USE FOR Unknown Indication

Lorazepam
    Indication: Drug USE FOR Unknown Indication

Lansoprazole
    Indication: Drug USE FOR Unknown Indication

Lactulose
    Indication: Drug USE FOR Unknown Indication

Hydrocortisone
    Indication: Drug USE FOR Unknown Indication

Furosemide
    Administration route: Oral
    Indication: Drug USE FOR Unknown Indication

Furosemide

Fragmin
    Indication: Drug USE FOR Unknown Indication

Fluconazole
    Indication: Drug USE FOR Unknown Indication

Dobutamine HCL
    Indication: Drug USE FOR Unknown Indication

Clexane
    Indication: Drug USE FOR Unknown Indication

Calcium Gluconate
    Indication: Drug USE FOR Unknown Indication

Calcium Chloride
    Indication: Drug USE FOR Unknown Indication

Bactroban
    Indication: Drug USE FOR Unknown Indication

Aquasept
    Indication: Drug USE FOR Unknown Indication

Amoxicillin
    Indication: Drug USE FOR Unknown Indication

Alfentanil
    Indication: Drug USE FOR Unknown Indication

Other drugs received by patient: Amoxicillin; Aspirin; Atrovent; Ciprofloxacin; Amoxicillin + Clavulanate Potassium; Erythromycin; Metoclopramide; Midodrine; Pantoprazole Sodium; Tazocin; Vancomycin; Zopiclone

Possible Rocephin side effects / adverse reactions in 24 month old male

Reported by a physician from China on 2007-01-11

Patient: 24 month old male weighing 13.0 kg (28.6 pounds)

Reactions: Haemolysis

Adverse event resulted in: life threatening event

Suspect drug(s):
Rocephin

Other drugs received by patient: Bricanyl; Ambroxol Hydrochloride