Ceftin
- Generic Name: cefuroxime axetil
- Brand Name: Ceftin
- Drug Class: Cephalosporins, 2nd Generation
Ceftin (Cefuroxime Axetil) side effects drug center
Ceftin Side Effects Center
What Is Ceftin?
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.
What Are Side Effects of Ceftin?
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).
Tell your doctor if you experience serious side effects of Ceftin including watery or bloody diarrhea, fever, chills, body aches, flu symptoms, chest pain, fast or pounding heartbeats, unusual bleeding, blood in your urine or dark colored urine, seizure (convulsions), confusion, weakness, jaundice (yellowing of the skin or eyes), severe blistering/peeling/red skin rash, bruising, severe tingling, numbness, pain, muscle weakness, increased thirst, loss of appetite, swelling, weight gain, shortness of breath, painful or difficult urination, or urinating less than usual or not at all.
Dosage for Ceftin
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.
What Drugs, Substances, or Supplements Interact with Ceftin?
Drug interactions with Ceftin include vaccines (for example, typhoid vaccine) and probenecid.
Ceftin During Pregnancy and Breastfeeding
Ceftin use during pregnancy may lead to adverse effects in the newborn. Ceftin is found in breast milk.Additional Information
Our Ceftin Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Ceftin 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);
- jaundice (yellowing of the skin or eyes);
- fever, chills, headache, muscle pain;
- light-headed feeling, like you might pass out;
- problems with your hearing;
- a seizure; or
- kidney problems--little or no urination, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath.
Common side effects may include:
- diarrhea;
- fever and body aches;
- nausea, vomiting; 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 Ceftin (Cefuroxime Axetil)
Ceftin Professional Information
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.
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 1,000-mg 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 U.S. 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 U.S. 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%) U.S. subjects discontinued medication due to adverse reactions. The discontinuations were primarily for gastrointestinal disturbances, usually diarrhea or vomiting. Thirteen (1.4%) U.S. pediatric subjects discontinued therapy due to the taste and/or problems with drug administration.
The adverse reactions in Table 7 are for U.S. 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 U.S. 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
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)
&Copy; Ceftin Patient Information is supplied by Cerner Multum, Inc. and Ceftin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.