ADVERSE REACTIONS
AUGMENTIN is generally well tolerated. The majority of side effects observed in clinical trials were of a mild and transient nature and less than 3% of patients discontinued therapy because of drug-related side effects. The most frequently reported adverse effects were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). The overall incidence of side effects, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported reactions include: Abdominal discomfort, flatulence, and headache.
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, and an occasional case of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. 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 increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been infrequently reported with AUGMENTIN. 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. A slight thrombocytosis was noted in less than 1% of the patients treated with AUGMENTIN. 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, 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
Below is a sample of reports where side effects / adverse reactions may be related to Augmentin. The information is not vetted and should not be cosidered as verified clinical evidence.
Possible Augmentin side effects / adverse reactions in 79 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2007-01-11
Patient: 79 year old female weighing 55.0 kg (121.0 pounds)
Reactions: Jaundice, Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Anaemia, Electrocardiogram Change, Pyrexia, Transaminases Increased
Adverse event resulted in: hospitalization
Suspect drug(s):
Enoxaparin Sodium
Dosage: dose: open label phase enoxaparin 40 mg
Start date: 2005-01-04
End date: 2005-01-13
Enoxaparin Sodium
Dosage: dose: code broken: enoxaparin 40 mg
Start date: 2005-01-14
End date: 2005-02-12
Augmentin
Start date: 2004-12-17
End date: 2004-12-24
Other drugs received by patient: Prednisone TAB; Atrovent; Bricanyl /00199202/; Tribemin; Micropirin; Elatrolet; Bezafibrate; Losec /00661201/; Aldactone; Mucolit; Siran; Acamol; Magnesium Sulfate (With Sodium Chloride); Hydrocortison; Hydrocortison; Tazocin; Norvasc; Digoxin; Ikacor; Slow-K; Pulmocare /00960601/; Sedural; Sedural; Calcimore; Elatrol
Possible Augmentin side effects / adverse reactions in 81 year old male
Reported by a individual with unspecified qualification from United States on 2007-02-20
Patient: 81 year old male weighing 96.1 kg (211.4 pounds)
Reactions: Rash
Suspect drug(s):
Augmentin
Possible Augmentin side effects / adverse reactions in 78 year old female
Reported by a individual with unspecified qualification from France on 2007-03-01
Patient: 78 year old female
Reactions: Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Glucophage
Dosage: 1700,00 mg (850 mg, 2 in 1 d) oral
Administration route: Oral
Indication: Diabetes Mellitus
End date: 2006-08-30
Fozitec 10 Mg(10 MG, Tablet) (Fosinopril)
Dosage: 10,000 mg (10 mg, 1 in 1 d) oral
Administration route: Oral
Indication: Essential Hypertension
End date: 2006-08-30
Diamicron (30 MG, Tablet), (Gliclazide)
Dosage: 0,75 mg (0,75 mg, 1 d) oral
Administration route: Oral
Indication: Diabetes Mellitus
End date: 2006-08-30
Augmentin
Dosage: 2,00 gm ( 1gm,2 in 1 d) intravenous (not otherwise specified)
Indication: Drug USE FOR Unknown Indication
Start date: 2006-08-27
End date: 2006-08-31
Amaryl
Dosage: 2,00 mg (2 mg,1 in 1 d) oral
Administration route: Oral
Indication: Diabetes Mellitus
End date: 2006-08-30
Ofloxacin
Dosage: 1,00 dosage forms (1 dosage forms, 1 in 1 d) intravenous (not otherwise specified)
Indication: Drug USE FOR Unknown Indication
Start date: 2006-08-28
End date: 2006-08-29
Amlodipine Besylate
Dosage: 5,00 mg (5 mg, 1 in 1 d) oral
Administration route: Oral
Indication: Essential Hypertension
End date: 2006-09-03
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