ADVERSE REACTIONS: 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. General Disorders and Administration Site Conditions —injection site pain (0.6%). Hypersensitivity — rash (1.7%). Less frequently reported (< 1%) were pruritus, fever or chills. Infections and Infestations —genital fungal infection (0.1%). 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. Blood and Lymphatic Disorders —granulocytopenia (0.9%), coagulopathy (0.4%). Gastrointestinal — diarrhea/loose stools (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 ). Hepatic — elevations of aspartate aminotransferase (AST) (3.1%) or alanine aminotransferase (ALT) (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%). Investigations —blood creatinine increased (0.6%). 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 — pancreatitis, stomatitis and glossitis. Genitourinary — oliguria, ureteric obstruction, post-renal acute renal failure. Dermatologic — exanthema, allergic dermatitis, urticaria, edema; 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. Hematological Changes – Isolated cases of agranulocytosis (< 500/mm 3) have been reported, most of them after 10 days of treatment and following total doses of 20 g or more. Nervous System Disorders – convulsion Other Adverse Reactions – symptomatic precipitation of ceftriaxone calcium salt in the gallbladder, kernicterus, oliguria, and anaphylactic or anaphylactoid reactions. 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 (see PRECAUTIONS ). 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 EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.