August 1, 2015
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Ceftin

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Ceftin




Ceftin Side Effects Center

Pharmacy Editor: Eni Williams, PharmD, PhD

Last reviewed on RxList 4/8/2015

Ceftin (cefuroxime) is a cephalosporin antibiotic. 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, drowsiness, itching/swelling, rash, nausea, vomiting, abdominal pain, stomach upset, gas, headache, itching or rash, hives, cough, stuffy nose, stiff or tight muscles, muscle pain, joint pain or swelling, restlessness, irritability, hyperactivity, vaginal itching or discharge, unusual or unpleasant taste in the mouth white patches or sores in the mouth, and diaper rash (in infants taking liquid cefuroxime).

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

The following serious and otherwise important adverse reaction is described in greater detail in the WARNINGS AND PRECAUTIONS section of the label:

Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Tablets

Multiple-dose Dosing Regimens with 7 to 10 Days' Duration: In multiple-dose clinical trials, 912 subjects were treated with CEFTIN (125 to 500 mg twice daily). It is noted that 125 mg twice daily is not an approved dosage. Twenty (2.2%) subjects discontinued medication due to adverse reactions. Seventeen (85%) of the 20 subjects who discontinued therapy did so because of gastrointestinal disturbances, including diarrhea, nausea, vomiting, and abdominal pain. The percentage of subjects treated with CEFTIN who discontinued study drug because of adverse reactions was 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 reactions increased with the higher recommended doses.

The adverse reactions in Table 5 are for subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.

Table 5: Adverse Reactions ( ≥ 1%) after Multiple-dose Regimens with CEFTIN Tablets

Adverse Reaction CEFTIN
(n = 912)
Blood and lymphatic system disorders
  Eosinophilia 1%
Gastrointestinal disorders
  Diarrhea 4%
  Nausea/Vomiting 3%
Investigations
  Transient elevation in AST 2%
  Transient elevation in ALT 2%
  Transient elevation in LDH 1%

The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 912) treated with CEFTIN in multiple-dose clinical trials.

Immune System Disorders: Hives, swollen tongue.

Metabolism and Nutrition Disorders: Anorexia.

Nervous System Disorders: Headache.

Cardiac Disorders: Chest pain.

Respiratory Disorders: Shortness of breath.

Gastrointestinal Disorders: Abdominal pain, abdominal cramps, flatulence, indigestion, mouth ulcers.

Skin and Subcutaneous Tissue Disorders: Rash, itch

Renal and Urinary Disorders: Dysuria.

Reproductive System and Breast Disorders: Vaginitis, vulvar itch.

General Disorders and Administration Site Conditions: Chills, sleepiness, thirst.

Investigations: Positive Coombs' test.

5-Day Regimen: In clinical trials using CEFTIN 250 mg twice daily in the treatment of secondary bacterial infections of acute bronchitis, 399 subjects were treated for 5 days and 402 subjects were treated for 10 days. No difference in the occurrence of adverse reactions was found between the 2 regimens.

Early Lyme Disease with 20-Day Regimen: Two multicenter trials assessed CEFTIN 500 mg twice daily for 20 days. The most common drug-related adverse experiences were diarrhea (10.6%), 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 1,000mg dose of CEFTIN, 1,061 subjects were treated for uncomplicated gonorrhea.

The adverse reactions in Table 6 were for subjects treated with a single dose of 1,000 mg CEFTIN in US clinical trials.

Table 6: Adverse Reactions ( ≥ 1%) after Single-dose Regimen with 1,000-mg CEFTIN Tablets for Uncomplicated Gonorrhea

Adverse Reaction CEFTIN
(n = 1,061)
Gastrointestinal disorders
  Nausea/Vomiting 7%
  Diarrhea 4%

The following adverse reactions occurred in less than 1% but greater than 0.1% of subjects (n = 1,061) treated with a single dose of CEFTIN 1,000 mg for uncomplicated gonorrhea in US clinical trials.

Infections and Infestations: Vaginal candidiasis.

Nervous System Disorders: Headache, dizziness, somnolence.

Cardiac Disorders: Tightness/pain in chest, tachycardia.

Gastrointestinal Disorders: Abdominal pain, dyspepsia.

Skin and Subcutaneous Tissue Disorders: Erythema, rash, pruritus.

Musculoskeletal and Connective Tissue Disorders: Muscle cramps, muscle stiffness, muscle spasm of neck, lockjaw-type reaction.

Renal and Urinary Disorders: Bleeding/pain in urethra, kidney pain.

Reproductive System and Breast Disorders: Vaginal itch, vaginal discharge.

Oral Suspension

In clinical trials using multiple doses of CEFTIN, pediatric subjects (96.7% were younger than 12 years) were treated with CEFTIN (20 to 30 mg/kg/day divided twice daily up to a maximum dose of 500 or 1,000 mg/day, respectively). Eleven (1.2%) US subjects discontinued medication due to adverse reactions. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. Thirteen (1.4%) US pediatric subjects discontinued therapy due to the taste and/or problems with drug administration.

The adverse reactions in Table 7 are for US subjects (n = 931) treated with CEFTIN in multiple-dose clinical trials.

Table 7: Adverse Reactions ( ≥ 1%) after Multiple-dose Regimens with CEFTIN for Oral Suspension

Adverse Reaction CEFTIN
(n = 931)
Gastrointestinal disorders
  Diarrhea 9%
  Dislike of taste 5%
  Nausea/vomiting 3%
Skin and subcutaneous tissue disorders
  Diaper rash 3%

The following adverse reactions occurred in less than 1% but greater than 0.1% of US subjects (n = 931) treated with CEFTIN for oral suspension in multiple-dose clinical trials.

Infections and Infestations: Gastrointestinal infection, candidiasis, viral illness, upper respiratory infection, sinusitis, urinary tract infection.

Blood and Lymphatic System Disorders: Eosinophilia.

Psychiatric Disorders: Hyperactivity, irritable behavior.

Gastrointestinal Disorders: Abdominal pain, flatulence, ptyalism.

Skin and Subcutaneous Tissue Disorders: Rash.

Musculoskeletal and Connective Tissue Disorders: Joint swelling, arthralgia.

Reproductive System and Breast Disorders: Vaginal irritation.

General Disorders and Administration Site Conditions: Cough, fever.

Investigations: Elevated liver enzymes, positive Coombs' test.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of CEFTIN. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders

Hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia.

Gastrointestinal Disorders

Pseudomembranous colitis [see WARNINGS AND PRECAUTIONS].

Hepatobiliary Disorders

Hepatic impairment including hepatitis and cholestasis, jaundice.

Immune System Disorders

Anaphylaxis, serum sickness-like reaction.

Investigations

Increased prothrombin time.

Nervous System Disorders

Seizure, encephalopathy.

Renal and Urinary Disorders

Renal dysfunction.

Skin and Subcutaneous Tissue Disorders

Angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria.

Read the entire FDA prescribing information for Ceftin (Cefuroxime Axetil)

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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