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

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.

REPORTS OF SUSPECTED AUGMENTIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Augmentin side effects / adverse reactions in 22 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-13

Patient: 22 year old male weighing 57.1 kg (125.6 pounds)

Reactions: Respiratory Rate Increased, Viral Infection, Vomiting, Nausea, Chills, Urinary Tract Infection, Bone Pain, Pyrexia, Oropharyngeal Pain, Headache, Lower Respiratory Tract Infection, Haemoglobin Decreased, Skin Ulcer, Oxygen Saturation Decreased

Adverse event resulted in: hospitalization

Suspect drug(s):
HQK-1001
    Dosage: 40 mg/kg, 1 d, oral
    Administration route: Oral
    Indication: Sickle Cell Anaemia
    Start date: 2011-07-11
    End date: 2011-09-15

Augmentin
    Dosage: 625 mg, 2 in 1 d, oral
    Administration route: Oral
    Indication: Sepsis
    Start date: 2011-09-05
    End date: 2011-09-15

Augmentin
    Dosage: 1.2 mg, intravenous
    Indication: Sepsis
    Start date: 2011-09-05
    End date: 2011-09-05

Voltaren
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-09-05

Ferrous Sulfate TAB
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-11

Other drugs received by patient: Folic Acid; Codeine Sulfate

Possible Augmentin side effects / adverse reactions in 76 year old male

Reported by a physician from Ireland on 2011-10-21

Patient: 76 year old male

Reactions: Acute Hepatic Failure, Hepatitis

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Augmentin
    Dosage: 875/125 mg
    Indication: Bacterial Infection
    Start date: 2009-05-27

Nexium
    Administration route: Oral
    Indication: Duodenal Ulcer
    Start date: 2009-04-03

Fucidine CAP
    Indication: Bacterial Infection
    Start date: 2009-05-22

Lexapro
    Administration route: Oral
    Indication: Depression
    Start date: 2009-04-03

Seroquel
    Administration route: Oral
    Indication: Psychotic Disorder
    Start date: 2009-04-03

Rifadin
    Administration route: Oral
    Indication: Bacterial Infection
    Start date: 2009-05-22
    End date: 2009-05-27

Metronidazole
    Indication: Bacterial Infection
    Start date: 2009-05-22

Possible Augmentin side effects / adverse reactions in 74 year old male

Reported by a physician from Switzerland on 2011-10-24

Patient: 74 year old male

Reactions: Blood Bilirubin Increased, Blood Alkaline Phosphatase Increased, Gamma-Glutamyltransferase Increased, International Normalised Ratio Increased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Adverse event resulted in: hospitalization

Suspect drug(s):
Amoxicillin
    Dosage: 750 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-26
    End date: 2011-08-15

Clindamycin HCL
    Dosage: 600 mg, 3x/day
    Administration route: Oral
    Start date: 2011-07-26
    End date: 2011-08-15

Augmentin
    Dosage: 2.2 g, 3x/day
    Start date: 2011-07-07
    End date: 2011-07-24

Other drugs received by patient: Norvasc; Atorvastatin Calcium; Marcumar; Nexium; Aspirin; Ramipril