Medical Editor: John P. Cunha, DO, FACOEP
What Is Augmentin?
Augmentin (amoxicillin/clavulanate) is a combination antibiotic used to treat bacterial infections including sinusitis, pneumonia, ear infections, bronchitis, urinary tract infections, and infections of the skin.
What Are Side Effects of Augmentin?
Common side effects of Augmentin include:
- Nausea
- Vomiting
- Headache
- Diarrhea
- Gas
- Stomach pain
- Skin rash or itching
- White patches in your mouth or throat
- Vaginal yeast infection (itching or discharge)
Rare and severe side effects of Augmentin can include:
- watery or bloody diarrhea;
- pale or yellowed skin, dark colored urine, fever, confusion or weakness;
- easy bruising or bleeding;
- skin rash, bruising, severe tingling, numbness, pain, muscle weakness;
- agitation, confusion, unusual thoughts or behavior, seizures (convulsions);
- nausea, upper stomach pain, itching, loss of appetite, clay-colored stools, jaundice (yellowing of the skin or eyes); 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.
Augmentin During Pregnancy and Breastfeeding
Augmentin is not expected to be harmful to an unborn baby, but a woman should tell her doctor if she is pregnant or plans to become pregnant during treatment. Amoxicillin and clavulanate potassium can pass into breast milk and may harm a nursing baby. Do not use Augmentin without telling your doctor if you are breastfeeding a baby.
Additional Information
Our Augmentin 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.
SLIDESHOW
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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 eyes, skin pain, red or purple skin rash with 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);
- pale or yellowed skin, dark colored urine, fever, confusion or weakness;
- loss of appetite, upper stomach pain;
- little or no urination; or
- easy bruising or bleeding.
Common side effects may include:
- nausea, vomiting; diarrhea;
- rash, itching;
- vaginal itching or discharge; or
- diaper rash.
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.
QUESTION
Bowel regularity means a bowel movement every day. See AnswerSIDE EFFECTS
The following are discussed in more detail in other sections of the labeling:
- Anaphylactic reactions [see WARNINGS AND PRECAUTIONS]
- Hepatic Dysfunction [see WARNINGS AND PRECAUTIONS]
- CDAD [see WARNINGS AND PRECAUTIONS]
Clinical Trial 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.
In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. [See Clinical Studies]
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.
Gastrointestinal
Indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. [see WARNINGS AND PRECAUTIONS]
Hypersensitivity Reactions
Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. [see WARNINGS AND PRECAUTIONS]
Liver
Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN. It has been reported more commonly in the elderly, in males, or in patients on prolonged treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, treatment. The histologic findings on liver biopsy have consisted of predominantly cholestatic, hepatocellular, or mixed cholestatic hepatocellular changes. The onset of signs/symptoms of hepatic dysfunction may occur during or several weeks after therapy has been discontinued. The hepatic dysfunction, which may be severe, is usually reversible. Deaths have been reported. [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS]
Renal
Interstitial nephritis, hematuria, and crystalluria have been reported. [see OVERDOSE]
Hemic And Lymphatic Systems
Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly. [see DRUG INTERACTIONS]
Central Nervous System
Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.
Miscellaneous
Tooth discoloration (brown, yellow, or gray staining) has been reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.
Read the entire FDA prescribing information for Augmentin (Amoxicillin Clavulanate)
© Augmentin Patient Information is supplied by Cerner Multum, Inc. and Augmentin Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
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