Medical Editor: John P. Cunha, DO, FACOEP
What Is Ceftriaxone?
Ceftriaxone (ceftriaxone sodium and dextrose) Injection is an antibacterial drug used to treat conditions such as lower respiratory tract infections, skin and skin structure infections, urinary tract infections, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, and meningitis. Ceftriaxone is available in generic form.
What Are Side Effects of Ceftriaxone?
Common side effects of Ceftriaxone include:
- upset stomach,
- blood clots,
- pain or swelling in your tongue,
- a lump where the medicine was injected,
- vaginal itching or discharge,
- vaginal yeast infection,
- changes in taste, or
Dosage for Ceftriaxone
The recommended dose of Ceftriaxone is 1 to 2 grams once per day. Do not exceed 4 grams in one day. Talk to your doctor about your individual dosage recommendation.
What Drugs, Substances, or Supplements Interact with Ceftriaxone?
Ceftriaxone During Pregnancy and Breastfeeding
If you are pregnant, only use Ceftriaxone if clearly needed. Exercise caution if you are taking Ceftriaxone while breastfeeding.
Our Ceftriaxone (ceftriaxone sodium and dextrose) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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).
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%).
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.
In addition to the adverse reactions reported during clinical trials, the following adverse experiences have been reported during clinical practice in patients treated with ceftriaxone. 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 ceftriaxone and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both ceftriaxone and calciumcontaining 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 ceftriaxone 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.
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:
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.
To report SUSPECTED ADVERSE REACTIONS, contact Mylan Pharmaceuticals Inc. at 1-877- 446-3679 (1-877-4-INFO-RX). or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Read the entire FDA prescribing information for Ceftriaxone (Ceftriaxone Sodium and Dextrose Injection )