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Ceftin

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Ceftin

Ceftin Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Ceftin (cefuroxime) is a medication that belongs to the drug class, cephalosporin antibiotics. Ceftin is available as a generic drug and is prescribed to treat infections with susceptible bacteria including skin and middle ear infections, tonsillitis, throat infections, laryngitis, bronchitis, pneumonia, urinary tract infections, and gonorrhea. Common side effects of Ceftin include diarrhea, dizziness, headache, stomach upset, abdominal pain, nausea/vomiting, itching/swelling, rash, diarrhea, nausea, vomiting, abdominal pain, headache, rash, hives, vaginitis, and mouth ulcers.

Ceftin oral dose range in adults is from 125mg to 500mg twice daily for 7-10 days and dosage in children is usually weight based. Drug interactions with Ceftin include vaccines (for example, typhoid vaccine) and probenecid. Ceftin use during pregnancy may lead to adverse effects in the newborn. Ceftin is found in breast milk.

Our Ceftin 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.

Ceftin 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 any of these serious side effects:

  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • chest pain, fast or pounding heartbeats;
  • unusual bleeding;
  • blood in your urine;
  • seizure (convulsions);
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • jaundice (yellowing of the skin or eyes);
  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
  • increased thirst, loss of appetite, swelling, weight gain, feeling short of breath; or
  • painful or difficult urination, urinating less than usual or not at all.

Less serious side effects may include:

  • nausea, vomiting, stomach pain, mild diarrhea, gas, upset stomach;
  • cough, stuffy nose;
  • stiff or tight muscles, muscle pain;
  • joint pain or swelling;
  • headache, drowsiness;
  • feeling restless, irritable, or hyperactive;
  • white patches or sores inside your mouth or on your lips;
  • unusual or unpleasant taste in your mouth;
  • diaper rash in an infant taking liquid cefuroxime;
  • mild itching or skin rash; 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ceftin (Cefuroxime Axetil) »

What is Patient Information Overview?

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

Ceftin Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, or stomach pain may occur. Dizziness and drowsiness may occur less frequently, especially with higher doses. If any of these effects persist or worsen, notify 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 immediately if any of these unlikely but serious side effects occur: unusual tiredness/weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: yellowing of the eyes/skin, severe stomach/abdominal pain, persistent nausea/vomiting, dark urine, change in the amount of urine, signs of new infection (e.g., fever, persistent sore throat), easy bruising/bleeding, jerky movements, chest pain, mental/mood changes (such as confusion).

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a resistant bacteria. This condition may occur while receiving therapy or even weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have the following 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 (oral or vaginal fungal 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Ceftin (Cefuroxime Axetil)»

What is Prescribing information?

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

Ceftin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

CEFTIN (cefuroxime axetil) TABLETS IN CLINICAL TRIALS

Multiple-Dose Dosing Regimens

7 to 10 Days Dosing

Using multiple doses of cefuroxime axetil tablets, 912 patients were treated with cefuroxime axetil (125 to 500 mg twice daily). There were no deaths or permanent disabilities thought related to drug toxicity. Twenty (2.2%) patients discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. Seventeen (85%) of the 20 patients who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of cefuroxime axetil tablet-treated patients who discontinued study drug because of adverse events was very similar at daily doses of 1,000, 500, and 250 mg (2.3%, 2.1%, and 2.2%, respectively). However, the incidence of gastrointestinal adverse events increased with the higher recommended doses.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil tablets in multiple-dose clinical trials (n = 912 cefuroxime axetil-treated patients).

Table 4. Adverse Reactions-CEFTIN (cefuroxime axetil) Tablets
Multiple-Dose Dosing Regimens-Clinical Trials

Incidence ≥ 1% Diarrhea/loose stools 3.7%
Nausea/vomiting 3.0%
Transient elevation in AST 2.0%
Transient elevation in ALT 1.6%
Eosinophilia 1.1%
Transient elevation in LDH 1.0%
Incidence
< 1% but > 0.1%
Abdominal pain
Abdominal cramps
Flatulence
Indigestion
Headache
Vaginitis
Vulvar itch
Rash
Hives
Itch
Dysuria
Chills
Chest pain
Shortness of breath
Mouth ulcers
Swollen tongue
Sleepiness
Thirst
Anorexia
Positive Coombs test

5-Day Experience (see CLINICAL STUDIES section)

In clinical trials using CEFTIN (cefuroxime axetil) in a dose of 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 patients were treated for 5 days and 402 patients were treated for 10 days. No difference in the occurrence of adverse events was found between the 2 regimens.

In Clinical Trials for Early Lyme Disease With 20 Days Dosing

Two multicenter trials assessed cefuroxime axetil tablets 500 mg twice a day for 20 days. The most common drug-related adverse experiences were diarrhea (10.6% of patients), Jarisch-Herxheimer reaction (5.6%), and vaginitis (5.4%). Other adverse experiences occurred with frequencies comparable to those reported with 7 to 10 days dosing.

Single-Dose Regimen for Uncomplicated Gonorrhea

In clinical trials using a single dose of cefuroxime axetil tablets, 1,061 patients were treated with the recommended dosage of cefuroxime axetil (1,000 mg) for the treatment of uncomplicated gonorrhea. There were no deaths or permanent disabilities thought related to drug toxicity in these studies.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil in 1,000-mg single-dose clinical trials of cefuroxime axetil tablets in the treatment of uncomplicated gonorrhea conducted in the United States.

Table 5. Adverse Reactions-CEFTIN (cefuroxime axetil) Tablets
1-g Single-Dose Regimen for Uncomplicated Gonorrhea-Clinical Trials

Incidence ≥ 1% Nausea/vomiting 6.8%
Diarrhea 4.2%
Incidence
< 1% but > 0.1%
Abdominal pain
Dyspepsia
Erythema
Rash
Pruritus
Vaginal candidiasis
Vaginal itch
Vaginal discharge
Headache
Dizziness
Somnolence
Muscle cramps
Muscle stiffness
Muscle spasm of
Tightness/pain in
Bleeding/pain in
Kidney pain
Tachycardia
Lockjaw-type

Ceftin (cefuroxime axetil) For Oral Suspension In Clinical Trials

In clinical trials using multiple doses of cefuroxime axetil powder for oral suspension, pediatric patients (96.7% of whom were younger than 12 years of age) were treated with the recommended dosages of cefuroxime axetil (20 to 30 mg/kg/day divided twice a day up to a maximum dose of 500 or 1,000 mg/day, respectively). There were no deaths or permanent disabilities in any of the patients in these studies. Eleven US patients (1.2%) discontinued medication due to adverse events thought by the investigators to be possibly, probably, or almost certainly related to drug toxicity. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. During clinical trials, discontinuation of therapy due to the taste and/or problems with administering this drug occurred in 13 (1.4%) pediatric patients enrolled at centers in the United States.

The following adverse events were thought by the investigators to be possibly, probably, or almost certainly related to cefuroxime axetil for oral suspension in multiple-dose clinical trials (n = 931 cefuroxime axetil-treated US patients).

Table 6. Adverse Reactions-CEFTIN (cefuroxime axetil) for Oral Suspension
Multiple-Dose Dosing Regimens-Clinical Trials

Incidence ≥ 1% Diarrhea/loose stools8.6%
Dislike of taste 5.0%
Diaper rash 3.4%
Nausea/vomiting 2.6%
Incidence
< 1% but > 0.1%
Abdominal pain
Flatulence
Gastrointestinal
Candidiasis
Vaginal irritation
Rash
Hyperactivity
Irritable behavior
Eosinophilia
Positive direct Coombs
Elevated liver
Viral illness
Upper respiratory
Sinusitis
Cough
Urinary tract
Joint swelling
Arthralgia
Fever
Ptyalism

Postmarketing Experience With Ceftin (cefuroxime axetil) Products

In addition to adverse events reported during clinical trials, the following events have been identified during clinical practice in patients treated with CEFTIN (cefuroxime axetil) Tablets or with CEFTIN (cefuroxime axetil) for Oral Suspension and were reported spontaneously. Data are generally insufficient to allow an estimate of incidence or to establish causation.

General

The following hypersensitivity reactions have been reported: anaphylaxis, angioedema, pruritus, rash, serum sickness-like reaction, urticaria.

Gastrointestinal

Pseudomembranous colitis (see WARNINGS).

Hematologic

Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia, and increased prothrombin time.

Hepatic

Hepatic impairment including hepatitis and cholestasis, jaundice.

Neurologic

Seizure.

Skin

Erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis.

Urologic

Renal dysfunction.

Cephalosporin-Class Adverse Reactions

In addition to the adverse reactions listed above that have been observed in patients treated with cefuroxime axetil, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics: toxic nephropathy, aplastic anemia, hemorrhage, increased BUN, increased creatinine, false-positive test for urinary glucose, increased alkaline phosphatase, neutropenia, elevated bilirubin, and agranulocytosis.

Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment when the dosage was not reduced (see DOSAGE AND ADMINISTRATION and OVERDOSAGE). 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 Ceftin (Cefuroxime Axetil) »

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Ceftin - User Reviews

Ceftin 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 Ceftin 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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