Ceftriaxone Side Effects

Brand Names: Rocephin

Please note - some side effects for Ceftriaxone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ceftriaxone - for the Consumer

Ceftriaxone

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ceftriaxone:

Mild diarrhea; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; pain, swelling, or redness at the injection site; seizures; severe diarrhea; severe or persistent stomach or back pain with nausea and vomiting; vaginal irritation or discharge; yellowing of the skin or eyes.

Ceftriaxone Side Effects - for the Professional

Ceftriaxone

Ceftriaxone for Injection is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Ceftriaxone for Injection 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.

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 Ceftriaxone for Injection. 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 for Injection and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Ceftriaxone for Injection 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 Ceftriaxone for Injection 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. If seizures associated with drug therapy occur, the drug should be discontinued. Anticonvulsant therapy can be given if clinically indicated.

Side Effects by Body System

Gastrointestinal

Both pseudocholelithiasis (biliary "sludging") and true cholelithiasis (ceftriaxone-containing gallstone) have been reported in association with ceftriaxone dosages greater than 2 grams per day. A false-positive hepatobiliary scan occurred in a patient receiving ceftriaxone. A repeat test two weeks after discontinuation of ceftriaxone was normal.

Ceftriaxone-associated diarrhea may, in rare cases, be associated with C difficile pseudomembranous colitis. If diarrhea occurs and is unresponsive to discontinuation of the drug and/or standard therapy, pseudomembranous colitis should be considered.

Gastrointestinal side effects have included diarrhea (2.7%); nausea, vomiting, and dysgeusia (less than 1%); gallbladder sludge, biliary lithiasis, colitis, flatulence, dyspepsia, abdominal pain (less than 0.1%); cholelithiasis, and pseudomembranous colitis. Rare cases of pancreatitis, possibly secondary to biliary obstruction, have been reported. Stomatitis and glossitis have been reported during postmarketing experience.

Hematologic

Ceftriaxone-associated neutropenia and thrombocytopenia are reversible upon discontinuation of therapy. Fever and rash often accompany these conditions.

Nineteen cases (10 adults, 9 children) of immune hemolytic anemia have been reported, 9 of which were fatal. Symptoms may occur within minutes or weeks of drug administration. Initial symptoms included tachycardia, dyspnea, pallor, back or leg pain, and decrease in hemoglobin levels.

Hematologic side effects have included eosinophilia (6%), thrombocytosis (5.1%), and leukopenia (2.1%). Anemia, hemolytic anemia, neutropenia, lymphopenia, thrombocytopenia, and prothrombin time prolongation have been reported in less than 1% of patients. Agranulocytosis, lymphocytosis, leukocytosis, monocytosis, basophilia, and decreased prothrombin time have been reported in less than 0.1% of patients. Cephalosporins as a class have also been associated with aplastic anemia, hemorrhage and pancytopenia.

Hypersensitivity

A case of occupational contact dermatitis has been reported in a nurse who prepared cephalosporin solutions for administration to patients. The dermatitis resolved after the nurse stopped preparing the solutions.

A case of an acute generalized exanthematic pustulosis (AGEP) has been reported following administration of ceftriaxone. This was characterized by the appearance of an erythematous and generalized scarlatiniform rash with plaques covered by small nonfollicular pustules on the thighs, abdomen, and lower extremities. Ceftriaxone was discontinued and the AGEP was completely resolved after two weeks.

An allergic reaction manifested by itching, maculopapular rash, hyperthermia, flushing has been reported in a patient with X-linked agammaglobulinemia in the absence of IgE. T cell involvement was proposed as the mechanism.

Cross-sensitivity with other cephalosporins and penicillins may occur; however, the incidence is unknown.

Hypersensitivity side effects have included rash (1.7%), pruritus, fever, chills, anaphylaxis, and serum sickness. Allergic pneumonitis, allergic reaction, contact dermatitis, and acute generalized exanthematic pustulosis have also been reported. Cephalosporin class antibiotics have been associated with Stevens-Johnson syndrome, erythema multiforme, drug fever, serum sickness-like reaction, and toxic epidermal necrolysis.

Renal

Patients with underlying renal dysfunction may be at higher risk for these conditions.

Renal side effects have included elevations of BUN (1.2%), creatinine, urinary casts, renal precipitations, and nephrolithiasis. Cephalosporins as a class have been associated with renal dysfunction and toxic nephropathy.

Local

Local side effects have included pain, induration, and tenderness in 1% of patients. Phlebitis has occurred in less than 1% of patients after intravenous administration. Intramuscular injection has been associated with warmth, tightness and induration in 17% of patients receiving the 350 mg/mL solution and 5% of patients receiving the 250 mg/mL solution. Lidocaine 1% may be used as a diluent to decrease pain at the injection site.

Genitourinary

Genitourinary side effects have included moniliasis, vaginitis, glycosuria, and hematuria. Oliguria has been reported during postmarketing experience.

Hepatic

Hepatic side effects have included elevations of SGOT (3.1%), SGPT (3.3%), alkaline phosphatase (less than 1%), bilirubin (less than 1%), and jaundice (less than 0.1%). Cephalosporins as a class have been associated with hepatic dysfunction including cholestasis.

Nervous system

Nervous system side effects have included headache, dizziness, and seizures. Cephalosporin class antibiotics have been associated with reversible hyperactivity and hypertonia.

Endocrine

Endocrine side effects have included diaphoresis and flushing (less than 1%).

Respiratory

Respiratory side effects have rarely included bronchospasm and epistaxis.

Cardiovascular

Cardiovascular side effects have included palpitations (less than 0.1%) and thrombus.

Immunologic

Immunologic side effects have included life-threatening and fatal cases of immune hemolytic anemia, with symptoms of pallor, tachycardia, hypotension, dyspnea, and severe back pain. Most of these patients had preexisting hematologic or immunodeficiency disorders, and 1 had Crohn's disease.

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