Rocephin

• Generic Name: ceftriaxone
• Brand Name: Rocephin
• Drug Class: Cephalosporins, 3rd Generation

Rocephin (Ceftriaxone) side effects drug center

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PROFESSIONAL

CONSUMER

SIDE EFFECTS

• Overview
• Consumer Information
• Professional Information

 

Rocephin Side Effects Center

What Is Rocephin?

Rocephin (ceftriaxone sodium) for Injection is a cephalosporin antibiotic used to treat many kinds of bacterial infections, including severe or life-threatening forms such as meningitis. Rocephin is available in generic form.

What Are Side Effects of Rocephin?

Common side effects of Rocephin include:

• injection site reactions (swelling, redness, pain, a hard lump, or soreness),
• loss of appetite,
• nausea,
• vomiting,
• upset stomach,
• diarrhea,
• headache,
• dizziness,
• overactive reflexes,
• pain or swelling in your tongue,
• sweating, or
• vaginal itching or discharge.

Dosage for Rocephin

The usual adult daily dose is 1 to 2 grams given once a day (or in equally divided doses twice a day) depending on the type and severity of infection. Pediatric dosing depends on the condition being treated and the child's weight.

What Drugs, Substances, or Supplements Interact with Rocephin?

Other drugs may interact with Rocephin. Tell your doctor all prescription and over-the-counter medications and supplements you use.

Rocephin During Pregnancy and Breastfeeding

During pregnancy, Rocephin should be used only if prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Additional Information

Our Rocephin (ceftriaxone sodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Rocephin Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
• new signs of infection (fever, chills, sweating);
• nausea, vomiting, pain in your upper stomach that spreads to your back;
• pale or yellowed skin, dark colored urine;
• new or worsening breathing problems (wheezing, feeling short of breath);
• a blood cell disorder--headache, chest pain, dizziness, weakness, severe tingling or numbness; or
• kidney or bladder problems--pain in your side or lower back spreading to your groin, blood in your urine, painful or difficult urination, little or no urine.

Common side effects may include:

• symptoms of a blood cell disorder;
• diarrhea;
• vaginal itching or discharge;
• warmth, tight feeling, or a hard lump where the injection was given;
• rash; or
• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Rocephin (Ceftriaxone)

 

Rocephin Professional Information

SIDE EFFECTS

Rocephin is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Rocephin 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 Rocephin. 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 Rocephin and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin 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 Rocephin 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/mm³) 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.

Read the entire FDA prescribing information for Rocephin (Ceftriaxone)

&Copy; Rocephin Patient Information is supplied by Cerner Multum, Inc. and Rocephin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.