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Rocephin

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Rocephin

Rocephin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Rocephin (ceftriaxone sodium) for Injection is used to treat many kinds of bacterial infections, including severe or life-threatening forms such as meningitis. It is a cephalosporin antibiotic. This medication is available in generic form. Common side effects include swelling, redness, pain, or soreness at the injection. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache.

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

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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Rocephin in Detail - Patient Information: Side Effects

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 a serious side effect such as:

  • diarrhea that is watery or bloody;
  • fever, chills, swollen glands, rash or itching, joint pain, or general ill feeling;
  • white patches or sores inside your mouth or on your lips;
  • unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • pale or yellowed skin, dark colored urine, confusion or weakness;
  • urinating less than usual or not at all;
  • seizure (convulsions);
  • swelling, pain, or irritation where the injection was given;
  • chalky-colored stools, stomach pain just after eating a meal, nausea, heartburn, bloating, and severe upper stomach pain that may spread to your back; or
  • severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects may include:

  • a hard lump where the injection was given;
  • nausea, vomiting, upset stomach;
  • headache, dizziness, overactive reflexes;
  • pain or swelling in your tongue;
  • sweating; or
  • vaginal itching or discharge.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Rocephin Overview - Patient Information: Side Effects

SIDE EFFECTS: Swelling, redness, pain, or soreness at the injection site may occur. This medication may also infrequently cause loss of appetite, nausea, vomiting, diarrhea, or headache. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: dark urine, easy bruising/bleeding, fast/pounding/irregular heartbeat, seizures, unusual weakness/tiredness, yellowing eyes/skin, change in the amount of urine, chest pain, trouble breathing, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of these symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Rocephin (Ceftriaxone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Rocephin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Rocephin (ceftriaxone) is generally well tolerated. In clinical trials, the following adverse reactions, which were considered to be related to Rocephin (ceftriaxone) 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.

HYPERSENSITIVITY - rash (1.7%). Less frequently reported ( < 1%) were pruritus, fever or chills.

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.

GASTROINTESTINAL - diarrhea (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 SGOT (3.1%) or SGPT (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%).

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 (ceftriaxone) . 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 (ceftriaxone) and calcium-containing fluids. In some of these cases, the same intravenous infusion line was used for both Rocephin (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 Rocephin (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.

GASTROINTESTINAL - stomatitis and glossitis.

GENITOURINARY - oliguria.

DERMATOLOGIC - exanthema, allergic dermatitis, urticaria, edema. As with many medications, isolated cases of severe cutaneous adverse reactions (erythema multiforme, Stevens-Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported.

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.

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) »

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Rocephin - User Reviews

Rocephin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Rocephin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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