Levetrax Adverse Reactions

Clinical Trials: The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhea, rash, and hepatic enzymes increased. Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials. The following convention has been used for the classification of frequency: Very common (>1/10); Common (>1/100-<1/100); Uncommon (>1/1000-<1/100); Rare (>1/10000-<1/1000). (See Table 1.)

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Post Marketing: The following adverse reactions have been identified during post-marketing use of ceftriaxone. These reactions are reported from a population of uncertain size, therefore, it is not always possible to reliably estimate their frequency and/or establish a causal relationship to drug exposure.
Systemic Side Effects: Gastrointestinal Complaints: Pancreatitis, stomatitis and glossitis.
Hematological Changes: Isolated cases of agranulocytosis (<500/mm³) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more.
Skin Reactions: Acute generalized exanthematous pustulosis (AGEP) and isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's Syndrome/toxic epidermal necrolysis) have been reported.
Nervous System Disorders: Convulsion.
Infections and Infestations: Superinfection.
Other, Rare Side Effects: Symptomatic precipitation of ceftriaxone calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions.
Interaction with Calcium: Two in vitro studies, one using adult plasma and the other neonatal plasma from umbilical cord blood have been carried out to assess interaction of ceftriaxone and calcium. Ceftriaxone concentrations up to 1 mM (in excess of concentrations achieved in vivo following administration of 2 grams ceftriaxone infused over 30 minutes) were used in combination with calcium concentrations up to 12 mM (48 mg/dL). Recovery of ceftriaxone from plasma was reduced with calcium concentrations of 6 mM (24 mg/dL) or higher in adult plasma or 4 mM (16 mg/dL) or higher in neonatal plasma. This may be reflective of ceftriaxone calcium precipitation. 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 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 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. Cases of ceftriaxone precipitation in the urinary tract have been reported, mostly in children treated with high doses (e.g. ≥80 mg/kg/day or total doses exceeding 10 grams) and who have other risk factors (e.g. dehydration, confinement to bed). This event may be asymptomatic or symptomatic, and may lead to ureteric obstruction and postrenal acute renal failure, but is usually reversible upon discontinuation of Ceftriaxone.
Local Side Effects: In rare cases, phlebitis reactions occurred after i.v. administration. These may be minimized by slow (2-4 minutes) injection.
Investigations: Coombs test false positive, galactosemia test false positive, non-enzymatic methods for glucose determination false positive.