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Applies to ceftriaxone: injection powder for solution
Along with its needed effects, ceftriaxone may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking ceftriaxone:
Incidence not known
Some side effects of ceftriaxone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Incidence not known
Applies to ceftriaxone: injectable powder for injection, intramuscular kit, intravenous powder for injection, intravenous solution
This drug was generally well tolerated. The most common side effects were eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, and increased hepatic enzymes. Incidence of side effects was somewhat higher in children and with higher doses.
Very common (10% or more): Warmth/tightness/induration with IM injection (up to 17%)
Uncommon (0.1% to 1%): Injection site pain/discomfort, injection site induration, injection site tenderness, phlebitis after IV administration
Local side effects were increased if water was used as the diluent instead of lidocaine (lignocaine).
IM 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.
Nineteen cases (10 adults, 9 children) of immune hemolytic anemia have been reported, 9 of which were fatal. Symptoms occurred within minutes or weeks of drug administration. Initial symptoms included tachycardia, hypotension, dyspnea, pallor, back or leg pain, and decreased hemoglobin levels. Most of these patients had preexisting hematologic or immunodeficiency disorders, and 1 had Crohn's disease.
Bleeding and bruising (due to hypoprothrombinemia) may have been more prevalent in patients with liver or renal dysfunction, malnourished patients, patients with low vitamin K levels, and patients using this drug for a prolonged duration.
Hemolytic anemia and agranulocytosis have also been reported during postmarketing experience. Most cases of agranulocytosis (less than 500/mm3) were after 10 days of therapy and after total doses of at least 20 g.
Common (1% to 10%): Eosinophilia, thrombocytosis, leukopenia, thrombocytopenia, neutropenia
Uncommon (0.1% to 1%): Anemia, granulocytopenia, coagulopathy, hemolytic anemia, lymphopenia, prolonged prothrombin time
Rare (less than 0.1%): Agranulocytosis, lymphocytosis, leukocytosis, monocytosis, basophilia, decreased prothrombin time, hemolysis (fatal)
Frequency not reported: Bleeding, hypoprothrombinemia
Postmarketing reports: Coombs' test false positive
-Frequency not reported: Aplastic anemia, hemorrhage, positive direct Coombs' test
Shadows on sonograms of the gallbladder (mistaken for gallstones, but actually ceftriaxone-calcium precipitates) have been reported, primarily after doses higher than the standard recommended dose. Prospective studies showed variable incidence of precipitation with IV administration in children (more than 30% in some studies), but slow infusion (20 to 30 minutes) appeared to lower the incidence. Risk of forming precipitates was increased by duration of therapy exceeding 14 days, renal failure, dehydration, or total parenteral nutrition. Effect was usually asymptomatic, but clinical symptoms (e.g., pain, nausea, vomiting) have been reported. Precipitation was usually reversible upon drug discontinuation.
Both pseudocholelithiasis (biliary "sludging") and true cholelithiasis (ceftriaxone-containing gallstone) have been reported in association with doses greater than 2 g/day. A false-positive hepatobiliary scan occurred in a patient receiving this drug. A repeat test 2 weeks after this drug was discontinued was normal.
Hepatitis has also been reported during postmarketing experience.
Common (1% to 10%): Increased hepatic enzymes, increased ALT, increased AST
Uncommon (0.1% to 1%): Increased bilirubin
Rare (less than 0.1%): Hepatitis, jaundice, gallbladder sludge, biliary lithiasis, cholestatic jaundice
Frequency not reported: Transient elevations in liver function tests, shadows on sonograms of the gallbladder, cholelithiasis, pseudocholelithiasis, false-positive hepatobiliary scan
Postmarketing reports: Gallbladder precipitation
-Frequency not reported: Hepatic dysfunction, cholestasis
The onset of pseudomembranous colitis symptoms has been reported during or after antimicrobial treatment.
Common (1% to 10%): Diarrhea/loose stools
Uncommon (0.1% to 1%): Nausea, vomiting
Rare (less than 0.1%): Colitis, flatulence, dyspepsia, abdominal pain, pseudomembranous colitis
Frequency not reported: Clostridium difficile-associated diarrhea
Postmarketing reports: Pancreatitis, stomatitis, glossitis
Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Pruritus, maculopapular rash/exanthema, allergic dermatitis, diaphoresis
Rare (less than 0.1%): Urticaria
Frequency not reported: Severe dermatitis, exfoliative erythroderma, bruising
Postmarketing reports: Exanthema, severe cutaneous reactions, erythema multiforme, Stevens-Johnson syndrome, Lyell's syndrome/toxic epidermal necrolysis, acute generalized exanthematous pustulosis (AGEP)
-Frequency not reported: Contact dermatitis
A case of AGEP has been reported after administration of this drug. 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. This drug was discontinued and the AGEP was completely resolved after 2 weeks.
Allergic dermatitis and urticaria have also been reported during postmarketing experience.
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.
Common (1% to 10%): Increased BUN/serum urea
Uncommon (0.1% to 1%): Increased blood creatinine
Rare (less than 0.1%): Renal precipitations, nephrolithiasis, acute renal tubular necrosis
Postmarketing reports: Oliguria, ureteric obstruction, post-renal acute renal failure
-Frequency not reported: Renal dysfunction, toxic nephropathy
Cases of renal precipitation have been reported, primarily in children older than 3 years who received either high daily doses (e.g., at least 80 mg/kg/day) or total doses exceeding 10 g and who had other risk factors (e.g., fluid restrictions, confinement to bed). Risk of forming precipitates was increased in immobilized or dehydrated patients. Precipitation was reversible upon drug discontinuation.
Renal precipitation has also been reported during postmarketing experience.
Uncommon (0.1% to 1%): Genital fungal infection, urinary casts, candidiasis, vaginitis
Rare (less than 0.1%): Glycosuria, hematuria, crystalluria
Severe and sometimes fatal reactions have been reported in term and premature newborns (younger than 28 days) treated with IV ceftriaxone and calcium-containing IV solutions; a crystalline material (ceftriaxone-calcium precipitate) has been observed in the lungs and kidneys at autopsy. The same IV infusion line was used for this drug and calcium-containing solutions in some cases; precipitate was observed in the IV infusion line in some cases. Ceftriaxone and calcium-containing solutions infused at different times by different IV lines resulted in at least 1 neonate fatality; there was no crystalline material observed at autopsy.
Edema has also been reported during postmarketing experience.
Uncommon (0.1% to 1%): Pyrexia/fever, flushing
Rare (less than 0.1%): Edema, chills, drug fever, shivering
Postmarketing reports: Superinfection with nonsusceptible microorganisms, ceftriaxone-calcium precipitates/crystalline material
-Frequency not reported: Drug fever, superinfection
Uncommon (0.1% to 1%): Headache, dizziness, dysgeusia
Rare (less than 0.1%): Seizures
Postmarketing reports: Convulsion, vertigo, kernicterus
-Frequency not reported: Reversible hyperactivity, hypertonia, seizures triggered
Several cephalosporins have been implicated in triggering seizures, especially in patients with renal dysfunction when dose was not reduced.
Uncommon (0.1% to 1%): Increased alkaline phosphatase
Postmarketing reports: Galactosemia test false positive, false-positive test for urinary glucose (nonenzymatic methods)
-Frequency not reported: Increased LDH, false-positive test for urinary glucose
Rare (less than 0.1%): Anaphylaxis/anaphylactic-type reactions (e.g., bronchospasms), serum sickness
Frequency not reported: Allergic reaction, cross-sensitivity
Postmarketing reports: Anaphylaxis (anaphylactic shock, transient leukopenia, neutropenia, agranulocytosis, thrombocytopenia), anaphylactic reaction, anaphylactoid reaction, hypersensitivity
-Frequency not reported: Allergic reactions, serum sickness-like reaction
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 has occurred; however, the incidence is unknown.
Rare (less than 0.1%): Palpitations
Frequency not reported: Thrombus
Rare (less than 0.1%): Bronchospasm, epistaxis, allergic pneumonitis
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