Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS Ceftriaxone is generally well tolerated.
In clinical trials, the following adverse reactions, which were considered to be related to ceftriaxone 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.
General Disorders and Administration Site Conditions Injection site pain (0.6%) Hypersensitivity Rash (1.7%).
Less frequently reported (<1%) were pruritus, fever or chills.
Infections and Infestations Genital fungal infection (0.1%) 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.
Blood and Lymphatic Disorders Granulocytopenia (0.9%), coagulopathy (0.4%) Gastrointestinal Diarrhea/loose stools (2.7%).
Less frequently reported (<1%) were nausea or vomiting, and dysgeusia.
WARNINGS Hypersensitivity Reactions Before therapy with ceftriaxone for injection is instituted, careful inquiry should be made to determine whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins and other beta-lactam agents or other drugs.
This product should be given cautiously to penicillin and other beta-lactam agent-sensitive patients.
Antibacterial drugs should be administered with caution to any patient who has demonstrated some form of allergy, particularly to drugs.
Serious acute hypersensitivity reactions may require the use of subcutaneous epinephrine and other emergency measures.
As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions (i.e., anaphylaxis) have been reported.
Like all medications, Ceftriaxone Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: