Augmentin Side Effects

Generic name: amoxicillin / clavulanate

Note: This document contains side effect information about amoxicillin / clavulanate. Some of the dosage forms listed on this page may not apply to the brand name Augmentin.

Some side effects of Augmentin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to amoxicillin / clavulanate: oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking amoxicillin / clavulanate: 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 of amoxicillin / clavulanate may include:

• mild diarrhea, gas, stomach pain;

• nausea or vomiting;

• headache;

• skin rash or itching;

• white patches in your mouth or throat; or

• vaginal yeast infection (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.

For Healthcare Professionals

Applies to amoxicillin / clavulanate: oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet extended release

General

In general, side effects have been classified as mild and transient. Less than 3% of patients in clinical trials discontinued treatment due to side effects. The most frequent adverse reactions associated with immediate-release formulations have included diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%), and vaginitis (1%). Extended-release tablets have been most frequently associated with diarrhea (14.5%), vaginal mycosis (3.3%), nausea (2.1%), and loose stools (1.6%).

Gastrointestinal

Amoxicillin has been associated with hemorrhagic, sometimes inflammatory colitis, which typically affects the ascending colon. In addition, C difficile pseudomembranous colitis should be considered in patients who develop severe or prolonged diarrhea during or following amoxicillin-clavulanate therapy.

The incidence of diarrhea appears to increase with higher doses, and to decrease with twice daily dosing regimens (of immediate release formulations).

Gastrointestinal side effects have included diarrhea, nausea, abdominal pain, vomiting, indigestion, gastritis, generalized abdominal cramps, stomatitis, glossitis, mucocutaneous candidiasis, enterocolitis, black "hairy" tongue, small intestinal motor disturbances, hemorrhagic colitis, and pseudomembranous colitis. Colitis and Clostridium difficile pseudomembranous colitis have been reported with amoxicillin.

Hypersensitivity

Hypersensitivity reactions have occurred in up to 10% of patients, and may present as a skin rash, urticaria, pruritus, angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens-Johnson syndrome (rarely), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, exfoliative dermatitis, and toxic epidermal necrolysis. Anaphylaxis has been rarely reported (up to 0.2%). Hypersensitivity may play a role in some cases of amoxicillin-clavulanate-induced renal and hepatic toxicity. Urticarial rash, erythematous maculopapular rash, edema, hypotension, fever, eosinophilia, and dyspnea have been associated with hypersensitivity reactions to amoxicillin.

Hypersensitivity reactions to amoxicillin are more likely in patients with a history of allergy, asthma, hay fever, or urticaria.

Dermatologic

Dermatologic side effects have included rash, fixed drug eruption, bullous pemphigoid, erythema multiforme, Stevens-Johnson syndrome, and exfoliative dermatitis. Amoxicillin rashes occur more frequently in patients with unrecognized infectious mononucleosis. This rash is not necessarily indicative of a lifelong amoxicillin hypersensitivity.

Three out of four patients with infectious mononucleosis and an amoxicillin-associated rash displayed hypersensitivity to amoxicillin and ampicillin by skin tests and lymphocyte transformation tests. Two of these patients had side-chain-specific sensitization.

Hepatic

In cases of amoxicillin-clavulanate-induced hepatotoxicity, biopsy findings have typically revealed evidence of cholestatic injury. However, hepatocellular and mixed-type (cholestatic and hepatocellular) injury have also been documented. In many instances, hepatotoxicity may be due to a hypersensitivity. Onset of symptoms has been delayed in some patients, with presentation occurring after therapy has been discontinued. Prolonged treatment may increase the risk of hepatotoxicity. Elderly patients may be at increased risk of developing amoxicillin-clavulanate-induced jaundice. Fatalities are rare, but have been reported.

Rechallenge with amoxicillin alone has not been followed by a recurrence of hepatitis. However, rechallenge with amoxicillin-clavulanate has resulted in a relapse of liver injury. Therefore, the clavulanic acid may be the hepatotoxic part of the drug.

In patients with liver disease, frequent monitoring of liver function tests during amoxicillin-clavulanate therapy is recommended.

Hepatic side effects have included moderate elevations in serum transaminases (ALT and/or AST). Hepatic dysfunction (including cholestatic jaundice and hepatitis, increases in ALT and/or AST, serum bilirubin, and/or alkaline phosphatase) has been reported infrequently. Rare cases of jaundice, ductopenia, cholestatic hepatitis, granulomatous hepatitis, hepatic necrosis, and hepatocellular damage have also been reported. Less than 1 death per approximately 4 million prescriptions has been reported worldwide. Hepatic cholestasis and acute cytolytic hepatitis have been reported with amoxicillin use.

Renal

A 45-year-old female developed massive crystalluria, gross hematuria, and acute anuric renal failure after 12 days of intravenous amoxicillin-clavulanate at a dose of 2 g amoxicillin 3 times daily (not available in the United States). The crystals were composed of amoxicillin trihydrate. The renal failure and hematuria resolved over 6 days after discontinuation of the antibiotic.

Renal side effects have rarely included crystalluria, hematuria, acute renal failure, and acute interstitial nephritis, often associated with fever, rash, and eosinophilia.

Hematologic

Hematologic side effects associated with penicillins have included thrombocytopenia, anemia, hemolytic anemia, thrombocytopenic purpura, eosinophilia, agranulocytosis, and leukopenia. These are believed to be due to hypersensitivity and are usually reversible when the drug is discontinued. Mild to moderate thrombocytosis has been reported in less than 1% of patients treated with amoxicillin-clavulanate and 3.6% of patients treated with the extended-release tablets. Purpura, pancytopenia, granulocytopenia, medullary aplasia, prolongation of prothrombin time, and transient neutropenia have also been reported.

Amoxicillin has been shown to induce hemolytic anemia in rare cases. A case of bone marrow "maturation arrest" resulting in neutropenia and of Henoch-Schonlein purpura syndrome has been associated with amoxicillin-clavulanate.

A patient undergoing dental extraction and receiving warfarin anticoagulation therapy had prolonged bleeding times (PT and INR), and decreased hemoglobin and hematocrit. The bleeding was felt due to vitamin K deficiency as a result of depletion of intrinsic vitamin K-producing gut flora from use of amoxicillin for prophylaxis of subacute bacterial endocarditis.

Immunologic

Immunologic side effects associated with amoxicillin have included mucocutaneous candidiasis and vulvovaginal mycotic infection.

Nervous system

Nervous system side effects have rarely included agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, headache, insomnia, and reversible hyperactivity. Rare cases of psychosis associated with amoxicillin therapy have been reported, but may have been due to underlying infection or concomitant medication. Rarely, somnolence and aseptic meningitis have been reported with amoxicillin.

Genitourinary

Genitourinary side effects have included genital moniliasis (2.1%).

Other

Amoxicillin-clavulanate may cause false-positive urine glucose tests in patients using Clinitest(R) tablets. Enzymatic glucose oxidase tests should be used during amoxicillin-clavulanate therapy.

Other side effects have rarely included brown, yellow, or gray tooth discoloration, primarily in pediatric patients. Brushing or dental cleaning reduced or eliminated the discoloration in most cases.

Respiratory

Respiratory side effects associated with amoxicillin have included cough and rhinorrhea.

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