Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
The following are discussed in more detail in other sections of the labeling: • Anaphylactic reactions [see Warnings and Precautions (5.1)] • CDAD [see Warnings and Precautions (5.2)] 6.1 Clinical Trials 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 common adverse reactions (> 1%) observed in clinical trials of Amoxicillin for oral suspension were diarrhea, rash, vomiting, and nausea.
Triple therapy: The most frequently reported adverse events for patients who received triple therapy (Amoxicillin/clarithromycin/ lansoprazole) were diarrhea (7%), headache (6%), and taste perversion (5%).
Dual therapy:The most frequently reported adverse events for patients who received double therapy Amoxicillin/lansoprazole were diarrhea (8%) and headache (7%).
For more information on adverse reactions with clarithromycin or lansoprazole, refer to the Adverse Reactions section of their package inserts.
6.2 Postmarketing or Other Experience In addition to adverse events reported from clinical trials, the following events have been identified during postmarketing use of penicillins.
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 Amoxicillin.
Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Black hairy tongue, and hemorrhagic/pseudomembranous colitis.
5.1 Anaphylactic Reactions Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy including Amoxicillin.
Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins.
These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens.
There have been reports of individuals with a history of penicillin hypersensitivity who have experienced severe reactions when treated with cephalosporins.
Before initiating therapy with Amoxicillin, careful inquiry should be made regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens.
Like all medications, Amoxil can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: