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