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Augmentin XR Side Effects Center
Medical Editor: Charles Patrick Davis, MD, PhD
Augmentin XR (amoxicillin/clavulante potassium) Extended Release Tablets is a compound drug containing an antibiotic (amoxicillin) and a B-lactamase inhibitor (clavulanate) and is available in generic form. It is indicated for patients with community-acquired pneumonia or acute bacterial sinusitis. Some side effects include but are not limited to: mild diarrhea, gas, or stomach pain.
Augmentin XR (amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid) should be taken at the start of a meal to enhance absorption of amoxicillin and to minimize gastrointestinal intolerance. Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients taking penicillin or penicillin-related drugs like amoxicillin. People allergic to amoxicillin or clavulante potassium, or if they had liver problems caused by any Augmentin treatment, should avoid the drug. Prophylactic treatment with Augmentin may be associated with an increased risk of necrotizing enterocolitis in neonates. Caution should be exercised when Augmentin XR is administered to a nursing woman.
Our Augmentin XR (amoxicillin/clavulante potassium) 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.
Augmentin XR 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.
Stop using this medicine and call your doctor at once if you have a serious side effect such as:
- diarrhea that is watery or has blood in it;
- 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, seizure (convulsions);
- nausea, upper stomach pain, itching, loss of appetite, dark urine, 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.
Less serious side effects may include:
- mild diarrhea, gas, stomach pain;
- nausea or vomiting;
- skin rash or itching;
- white patches in your mouth or throat; or
- vaginal yeast infection (itching or discharge).
Read the entire detailed patient monograph for Augmentin XR (Amoxicillin Clavulanic Potassium)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Augmentin XR Overview - Patient Information: Side Effects
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 the doctor right away if any of these rare but serious side effects occur: dark urine, persistent nausea/vomiting, severe stomach/abdominal pain, yellowing eyes/skin, easy bruising/bleeding, new signs of infection (such as fever, persistent sore throat), unusual tiredness.
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 the following symptoms because these products may make them worse. Tell the doctor right away 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 yeast infection. Contact the 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, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
Amoxicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.
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 Augmentin XR (Amoxicillin Clavulanic Potassium)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Augmentin XR FDA Prescribing Information: Side 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 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, 5,643 patients have been treated with AUGMENTIN XR. The most frequently reported adverse reactions which were suspected or probably drug-related were diarrhea (15%), vaginal mycosis (3%) nausea (2%), and loose stools (2%). AUGMENTIN XR had a higher rate of diarrhea which required corrective therapy (4% versus 3% for AUGMENTIN XR and all comparators, respectively). Two percent of patients discontinued therapy because of drug-related adverse reactions.
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN products, including AUGMENTIN XR. 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: Diarrhea, nausea, vomiting, indigestion, gastritis, stomatitis, glossitis, black “hairy” tongue, mucocutaneous candidiasis, enterocolitis, and hemorrhagic/pseudo membranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment.
Hypersensitivity Reactions: Skin rashes, pruritus, urticaria, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported [see WARNINGS AND PRECAUTIONS].
Liver: A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted in patients treated with ampicillin-class antibiotics, but the significance of these findings is unknown. Hepatic dysfunction, including hepatitis and cholestatic jaundice, [see CONTRAINDICATIONS], increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been reported with AUGMENTIN or AUGMENTIN XR. 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, 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].
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. There have been reports of increased prothrombin time in patients receiving AUGMENTIN and anticoagulant therapy concomitantly.
Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity have been reported rarely.
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 XR (Amoxicillin Clavulanic Potassium)
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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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