DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

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

 
 



ADVERSE REACTIONS

The following are discussed in more detail in other sections of the labeling:

  • Anaphylactic reactions [see Warnings and Precautions ]
  • Hepatic Dysfunction [see Warnings and Precautions ]
  • CDAD [see Warnings and Precautions ]

Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse reactions were diarrhea/loose stools (9%), nausea (3%), skin rashes and urticaria (3%), vomiting (1%) and vaginitis (1%). Less than 3% of patients discontinued therapy because of drug‑related adverse reactions. The overall incidence of adverse reactions, and in particular diarrhea, increased with the higher recommended dose. Other less frequently reported adverse reactions (<1%) include: Abdominal discomfort, flatulence, and headache.

In pediatric patients (aged 2 months to 12 years), 1 US/Canadian clinical trial was conducted which compared 45/6.4 mg/kg/day (divided every 12 hours) of AUGMENTIN for 10 days versus 40/10 mg/kg/day (divided every 8 hours) of AUGMENTIN for 10 days in the treatment of acute otitis media. A total of 575 patients were enrolled, and only the suspension formulations were used in this trial. Overall, the adverse reactions seen were comparable to that noted above; however, there were differences in the rates of diarrhea, skin rashes/urticaria, and diaper area rashes. [See Clinical Studies ]

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of AUGMENTIN.  Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to AUGMENTIN.

Gastrointestinal:  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 and Precautions ]

Hypersensitivity Reactions: Pruritus, angioedema, serum sickness–like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), erythema multiforme, Stevens‑Johnson syndrome, acute generalized exanthematouspustulosis, hypersensitivity vasculitis, and cases of exfoliative dermatitis (including toxic epidermal necrolysis) have been reported. [see Warnings and Precautions ]

Liver: Hepatic dysfunction, including hepatitis and cholestatic jaundice, increases in serum transaminases (AST and/or ALT), serum bilirubin, and/or alkaline phosphatase, has been 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. Deaths have been reported. [see Contraindications Warnings and Precautions ]

Renal:Interstitial nephritis, hematuria, and crystalluria have been reported. [see Overdosage ]

Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosishave been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. 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. [see Drug Interactions ]

Central Nervous System: Agitation, anxiety, behavioral changes, confusion, convulsions, dizziness, insomnia, and reversible hyperactivity have been reported.

Miscellaneous: Tooth discoloration (brown, yellow, or gray staining) has been 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

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 considered as verified clinical evidence.

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



See index of all Augmentin side effect reports >>

Drug label data at the top of this Page last updated: 2013-03-06

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2015