Lorabid Side Effects

Generic name: loracarbef

Note: This document contains side effect information about loracarbef. Some of the dosage forms listed on this page may not apply to the brand name Lorabid.

Some side effects of Lorabid may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to loracarbef: oral capsule, oral powder for reconstitution

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

• diarrhea that is watery or bloody;

• seizure (convulsions);

• fever, sore throat, and joint pain with a severe blistering, peeling, and red skin rash;

• easy bruising or bleeding, unusual weakness; or

• skin rash, bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects of loracarbef (the active ingredient contained in Lorabid) may include:

• mild itching or skin rash;

• mild nausea, vomiting, stomach pain, loss of appetite;

• warmth, redness, or tingling under your skin;

• headache;

• dizziness, drowsiness; or

• vaginal itching or discharge.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to loracarbef: oral capsule, oral powder for reconstitution

General

Loracarbef (the active ingredient contained in Lorabid) is generally well tolerated.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (4.1%), nausea (1.9%), vomiting (1.4%), abdominal pain (1.4%), and anorexia. The incidence of side effects increases with higher doses. Pseudomembranous colitis has been reported in patients treated with beta-lactam antibiotics.

Nervous system

Nervous system side effects have included headache (2.9%), somnolence, insomnia, and dizziness. Some beta-lactam antibiotics have been associated with seizures in renally impaired patients.

Hypersensitivity

Hypersensitivity reactions have included rash (1.2%), urticaria, pruritus, and erythema multiforme. Anaphylaxis, serum-sickness-like reactions, and Stevens-Johnson syndrome have been reported rarely. Beta-lactam antibiotics have been associated with toxic epidermal necrolysis,

Respiratory

Respiratory side effects have included rhinitis (1.6%).

Hematologic

Hematologic side effects have included transient thrombocytopenia, leukopenia, and eosinophilia. Beta-lactam antibiotics as a class have been associated with agranulocytosis, aplastic anemia, hemolytic anemia, hemorrhage, positive direct Coombs' test, pancytopenia, neutropenia, and prolonged prothrombin time.

Renal

Renal side effects have included transient elevations in serum creatinine and BUN. Some beta-lactam antibiotics have been associated with toxic nephropathy.

Hepatic

Hepatic side effects have included transient elevations in AST (SGOT), ALT (SGPT), and alkaline phosphatase. Hepatic dysfunction including cholestasis with or without jaundice has been rarely reported. Some beta-lactam antibiotics have been associated with LDH elevations.

A 73-year-old man developed itching and jaundice, pale stools, and right upper quadrant pain two weeks after completion of a four week course of loracarbef for pneumonia. Bilirubin, AST, ALT, alkaline phosphatase levels were elevated. Liver biopsy showed widening of portal areas, pericellular fibrosis, and irregular fibrous bands in the parenchyma. Swollen hepatocytes and cholestasis in the cytoplasma and canaliculi were observed. Lab values returned to normal after 10 weeks.

Cardiovascular

Cardiovascular side effects have included vasodilatation.

Genitourinary

Genitourinary side effects have included vaginitis (1.3%) and vaginal moniliasis (1.1%).

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