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Augmentin XR (Amoxicillin / Clavulanate Potassium) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In clinical trials, 5,643 patients have been treated with AUGMENTIN XR. The majority of side effects observed in clinical trials were of a mild and transient nature; 2% of patients discontinued therapy because of drug-related side effects. The most frequently reported adverse effects which were suspected or probably drug-related were diarrhea (14.5%), vaginal mycosis (3.3%) nausea (2.1%), and loose stools (1.6%). AUGMENTIN XR had a higher rate of diarrhea which required corrective therapy (3.8% versus 2.6% for AUGMENTIN XR and all comparators, respectively).

The following adverse reactions have been reported for ampicillin-class antibiotics:

Gastrointestinal

Diarrhea, nausea, vomiting, 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).

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 (rarely Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, hypersensitivity vasculitis, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise. Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with oral penicillin (see WARNINGS).

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 infrequently 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. On rare occasions, deaths have been reported (less than 1 death reported per estimated 4 million prescriptions worldwide). These have generally been cases associated with serious underlying diseases or concomitant medications.

Renal

Interstitial nephritis and hematuria have been reported rarely. Crystalluria has also been reported.

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 rarely reported. Most reports occurred in pediatric patients. Discoloration was reduced or eliminated with brushing or dental cleaning in most cases.



REPORTS OF SUSPECTED AUGMENTIN XR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Augmentin XR. The information is not vetted and should not be considered as verified clinical evidence.

Possible Augmentin XR side effects / adverse reactions in 29 year old male

Reported by a health professional (non-physician/pharmacist) from Spain on 2012-04-25

Patient: 29 year old male

Reactions: Migraine, Rash Generalised, Ear Pain, Headache, Pyrexia, Erythema, Toxic Skin Eruption, Infection

Adverse event resulted in: hospitalization

Suspect drug(s):
Ibuprofen
    Administration route: Oral
    Indication: Pain
    Start date: 2009-04-16
    End date: 2009-04-20

Augmentin XR
    Dosage: 1000 / 62.5 mg
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2009-04-16
    End date: 2009-04-20

Viramune
    Administration route: Oral
    Indication: Asymptomatic HIV Infection
    Start date: 2009-04-14
    End date: 2009-04-24

Emtricitabine and Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2009-04-14
    End date: 2009-04-24



See index of all Augmentin XR side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-01

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