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Amoxil (Amoxicillin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

As with other penicillins, it may be expected that untoward reactions will be essentially limited to sensitivity phenomena. They are more likely to occur in individuals who have previously demonstrated hypersensitivity to penicillins and in those with a history of allergy, asthma, hay fever, or urticaria. The following adverse reactions have been reported as associated with the use of penicillins:

Infections and Infestations

Mucocutaneous candidiasis.

Gastrointestinal

Nausea, vomiting, diarrhea, black hairy tongue, and hemorrhagic/pseudomembranous colitis.

Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (See WARNINGS.)

Hypersensitivity Reactions

Anaphylaxis (See WARNING)

Serum sickness−like reactions, erythematous maculopapular rashes, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, hypersensitivity vasculitis and urticaria have been reported.

NOTE: These hypersensitivity reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, amoxicillin should be discontinued unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to amoxicillin therapy.

Liver

A moderate rise in AST (SGOT) and/or ALT (SGPT) has been noted, but the significance of this finding is unknown. Hepatic dysfunction including cholestatic jaundice, hepatic cholestasis and acute cytolytic hepatitis have been reported.

Renal

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.

Central Nervous System

Reversible hyperactivity, agitation, anxiety, insomnia, confusion, convulsions, behavioral changes, and/or dizziness 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.

Combination Therapy with Clarithromycin and Lansoprazole

In clinical trials using combination therapy with amoxicillin plus clarithromycin and lansoprazole, and amoxicillin plus lansoprazole, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with amoxicillin, clarithromycin, or lansoprazole.

Triple Therapy

Amoxicillin/Clarithromycin/Lansoprazole

The most frequently reported adverse events for patients who received triple therapy were diarrhea (7%), headache (6%), and taste perversion (5%). No treatment-emergent adverse events were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy

Amoxicillin/Lansoprazole

The most frequently reported adverse events for patients who received amoxicillin three times daily plus lansoprazole three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse events were observed at significantly higher rates with amoxicillin three times daily plus lansoprazole three times daily dual therapy than with lansoprazole alone.

For more information on adverse reactions with clarithromycin or lansoprazole, refer to their package inserts, ADVERSE REACTIONS.



REPORTS OF SUSPECTED AMOXIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Amoxil. The information is not vetted and should not be considered as verified clinical evidence.

Possible Amoxil side effects / adverse reactions in 66 year old male

Reported by a consumer/non-health professional from United Kingdom on 2011-10-14

Patient: 66 year old male

Reactions: Blood Pressure Increased, Respiratory Disorder, Nasopharyngitis, Malaise, Asthenia

Suspect drug(s):
Xalatan

Penicillin NOS

Amoxil



Possible Amoxil side effects / adverse reactions in 55 year old female

Reported by a health professional (non-physician/pharmacist) from Singapore on 2011-10-28

Patient: 55 year old female

Reactions: Angioedema

Suspect drug(s):
Acetaminophen

Acetylsalicylic Acid SRT

Amoxil



Possible Amoxil side effects / adverse reactions in 45 year old male

Reported by a health professional (non-physician/pharmacist) from Singapore on 2011-11-23

Patient: 45 year old male

Reactions: Angioedema

Suspect drug(s):
Acetylsalicylic Acid SRT

Amoxil



See index of all Amoxil side effect reports >>

Drug label data at the top of this Page last updated: 2008-06-16

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