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.
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REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO AUGMENTIN XR
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 cosidered as verified clinical evidence.
Possible Augmentin XR side effects / adverse reactions in 71 year old male
Reported by a physician from United States on 2007-02-05
Patient: 71 year old male
Reactions: Weight Decreased, Hypoglycaemia, Rash, Somnolence, Fatigue, Hepatotoxicity, Dizziness, Asthenia, Lung Infiltration, Cough, Infection
Suspect drug(s):
Augmentin XR
Other drugs received by patient: Prilosec; Allegra-D 12 Hour; Multi-Vitamin; Azithromycin; Advair Diskus 100/50; Allergy Injections; Lipitor; Levaquin
Possible Augmentin XR side effects / adverse reactions in 57 year old female
Reported by a consumer/non-health professional from United States on 2007-06-01
Patient: 57 year old female
Reactions: Therapeutic Response Delayed
Suspect drug(s):
Augmentin XR
Other drugs received by patient: Multiple Medications
Possible Augmentin XR side effects / adverse reactions in 37 year old female
Reported by a consumer/non-health professional from United States on 2007-06-01
Patient: 37 year old female
Reactions: Pruritus, Urticaria, Erythema
Suspect drug(s):
Augmentin XR
Other drugs received by patient: Celexa; Calcium Chloride; Ascorbic Acid; Folic Acid
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