The most frequent adverse reactions recorded with ceftriaxone in clinical trials are eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, and an increase in hepatic enzyme activity.
The incidence of adverse reactions is given in accordance with the following classification: very often (≥1 / 10); often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10,000, <1/1000); very rarely (<1/10 000), including isolated cases.
Undesirable reactions are grouped according to the classes of systems of the medical dictionary authorities for regulatory activities MedDRA.
Infectious and parasitic diseases: infrequently - mycoses of genital organs; rarely - pseudomembranous colitis.
Violations of the blood and lymphatic system: often - thrombocytopenia, leukopenia, eosinophilia; infrequently - granulocytopenia, anemia, coagulopathy.
Disturbances from the nervous system: infrequently - headache and dizziness.
Disturbances from the respiratory system, chest and mediastinal organs: rarely - bronchospasm.
Disorders from the gastrointestinal tract: often - diarrhea, unformed stool; infrequently - nausea, vomiting.
Disturbances from the liver and bile ducts: often - increased activity of "hepatic" enzymes (aspartate aminotransferase (ACT), alanine aminotransferase (ALT), alkaline phosphatase (alkaline phosphatase)).
Disturbances from the skin and subcutaneous tissues: often - a rash; infrequently itching; rarely - hives.
Disorders from the kidneys and urinary tract: rarely - hematuria, glucosuria.
General disorders and disorders at the site of administration: infrequently - phlebitis, pain at the injection site, fever; rarely - swelling, chills.
Impact on the results of laboratory and instrumental studies: infrequently - an increase in the concentration of creatinine in the blood.
Post-Business Monitoring
The side effects observed with the use of ceftriaxone in post-marketing period are described below. The definition of often observed side effects, as well as their association with the use of ceftriaxone, is not always possible, since it is impossible to establish the exact size of the patient population.
Disorders from the gastrointestinal tract: pancreatitis, stomatitis, glossitis, taste disorder.
Violations of the blood and lymphatic system: thrombocytosis, increased thromboplastin and prothrombin time, decreased prothrombin time, hemolytic anemia. Individual cases of agranulocytosis (<500 cells / μl) are described, most of them developed after 10 days of treatment and a cumulative dose of 20 g or more was used.
Immune system disorders: anaphylactic shock, hypersensitivity.
Disturbances from the skin and subcutaneous tissuesAcute generalized exanthematous pustulosis, individual cases of severe adverse reactions (exudative erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome)).
Disturbances from the nervous system: convulsions.
Hearing disorders and labyrinthine disorders: Vertigo.
Infectious and parasitic diseases: superinfection.
The following undesirable reactions are also known: Formation of calcium salt precipitates ceftriaxone in the gallbladder with the appropriate symptoms, bilirubin encephalopathy, hyperbilirubinemia, oliguria, vaginitis, increased sweating, "flushing", hypersensitivity pneumonitis, nasal bleeding, jaundice, palpitations, serum sickness, and anaphylactic or anaphylactoid reactions.
Some fatal cases of precipitates formation in the lungs and kidneys have been described based on the results of an autopsy study in newborns receiving ceftriaxone and calcium-containing solutions.In some cases, one venous access was used, and the formation of precipitates was observed directly in the system for intravenous administration. Also, at least one fatal case with different venous accesses and at different times of drug administration ceftriaxone and calcium-containing solutions. At the same time, according to the results of the autopsy study, no precipitates were found in this newborn. Similar cases were observed only in newborns.
Cases of formation of ceftriaxone precipitates in the urinary tract were recorded, mainly in children who received either large daily doses of the drug (> 80 mg / kg / day) or cumulative doses greater than 10 g, and who had additional risk factors (dehydration, bed rest) . The formation of precipitates in the kidneys can be asymptomatic or manifest clinically, can lead to ureteral obstruction and postrenal acute renal failure. This undesirable phenomenon is reversible and disappears after cessation of ceftriaxone therapy.
General disorders and disorders at the site of administration: phlebitis after intravenous administration. It can be avoided by injecting the drug slowly for 5 minutes, preferably in a large vein.
Intramuscular injection without lidocaine is painful.
Impact on the results of laboratory and instrumental studies: in the treatment of ceftriaxone, false positive results of Coombs test may be noted in patients. Like other antibiotics, ceftriaxone can give a false positive test result for galactosemia. False positive results can be obtained in the determination of glucose in urine by non-enzyme methods, therefore, during therapy with the drug Ceftriaxone Glucosuria, if necessary, should be determined only by the enzyme method.
Ceftriaxone may cause an unreliable decrease in the glycemic index obtained with some blood glucose monitoring devices. Refer to the instruction manual for the device you are using. If necessary, alternative methods for determining blood glucose should be used.