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Augmentin XR

Last reviewed on RxList: 1/24/2019
Augmentin XR Side Effects Center

Last reviewed on RxList 1/24/2019

Augmentin XR (amoxicillin/clavulante potassium) Extended Release Tablets is a combination of an antibiotic and a B-lactamase inhibitor indicated for patients with community-acquired pneumonia or acute bacterial sinusitis. Augmentin XR is available in generic form. Side effects of Augmentin XR include:

The recommended dose of Augmentin XR to treat bacterial sinusitis is 2 tablets every 12 hours, for a duration of 10 days. The recommended dose of Augmentin XR to treat pneumonia is 2 tablets every 12 hours, for 7 to 10 days. Augmentin XR may interact with allopurinol, probenecid, blood thinners, or other antibiotics. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Augmentin XR; it is not expected to be harmful to a fetus. Augmentin XR can make birth control pills less effective. Talk to your doctor about using a non-hormone method of birth control. Augmentin XR can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

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.

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Augmentin XR Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody;
  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • loss of appetite, upper stomach pain, jaundice (yellowing of the skin or eyes);
  • easy bruising or bleeding;
  • little or no urination; 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.

Common side effects may include:

  • nausea, diarrhea; 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 Augmentin XR (Amoxicillin Clavulanic Potassium)

QUESTION

Bowel regularity means a bowel movement every day. See Answer
Augmentin XR Professional Information

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

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.

Postmarketing Experience

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].

Renal: Interstitial nephritis, hematuria, and crystalluria have been reported [see OVERDOSAGE].

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)

Related Resources for Augmentin XR

Read the Augmentin XR User Reviews »

© Augmentin XR Patient Information is supplied by Cerner Multum, Inc. and Augmentin XR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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