RiteMED Meropenem Trihydrate Adverse Reactions

Adverse reactions reported in 1 % or more of patients receiving meropenem include gastrointestinal (GI) effects (diarrhea, nausea, vomiting, constipation) local reactions (pain, edema and inflammation at injection site, phlebitis/thrombophlebitis), headache, anemia, rash, pruritus, sepsis, apnea, shock, glossitis, oral candidiasis, and thrombocytosis.
In children, the most common adverse events reported as possibly, probably, or definitely related to meropenem include diarrhea, rash (mostly diaper area moniliasis), nausea, vomiting, oral moniliasis, and glossitis.
Additional adverse reactions that were reported irrespective of relationship to meropenem therapy include: Body as a Whole: Abdominal enlargement, chills, fever, infection, pain (abdominal, back, chest, pelvic).
Hypersensitivity Reactions/Dermatologic: angioedema, eosinophilia, erythema multiforme, exfoliative dermatitis, manifestations of anaphylaxis, skin ulcer, Stevens-Johnson syndrome, sweating, superinfection, toxic epidermal necrolysis, urticaria.
Nervous System: Agitation/delirium, anxiety, asthenia, confusion, depression, dizziness, hallucinations, insomnia, mental disturbances, nervousness, neuropathy, paresthesia, seizure/convulsion, somnolence.
Cardiovascular: Bradycardia, heart arrest, heart failure, hypertension, hypotension, myocardial infarction, peripheral vascular disorder, pulmonary embolus, syncope, tachycardia.
Gastrointestinal: Anorexia, dyspepsia, flatulence, GI hemorrhage, hemoperitoneum, ileus, intestinal obstruction, melena, pseudomembranous colitis, tooth or tongue discoloration.
Metabolic/Nutritional: Hypoglycemia, hypokalemia, hypomagnesemia, hypoxia, peripheral edema.
Respiratory: Asthma, increased cough, dyspnea, epistaxis, lung edema, pharyngitis, pleural effusion, pneumonia, respiratory disorder.
Genitourinary: Increased creatinine and blood urea nitrogen (BUN); dysuria, urinary incontinence, presence of red blood cells in urinalysis, kidney failure, renal impairment, vaginal candidiasis/moniliasis, vaginitis.
For patients with varying degrees of renal impairment, the incidence of heart failure, kidney failure, seizure and shock reported irrespective of relationship to meropenem increased in patients with moderately severe renal impairment.
Hepatic: Increased alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, lactate dehydrogenase (LDH), gamma-glutamyltransferase, and bilirubin; cholestatic jaundice/jaundice, hepatic failure, hepatitis.
Hematologic: Increased platelets, eosinophils; decreased platelets, hemoglobin, hematocrit, white blood cells; abnormal/shortened prothrombin time and partial thromboplastin time; agranulocytosis, anemia, hemolytic anemia, hypervolemia, hypochromic anemia, leukocytosis, leukopenia, neutropenia, positive Coombs' test, thrombocytopenia (with bleeding).
Other Adverse Effects: Accidental injury, taste perversion.