Amoxicillin
Generic name: amoxicillin (as the trihydrate, USP) · Brand names: Amoxil, Dispermox (no longer on the market), Larotid Suspension, Polymox Suspension (no longer on the market), Trimox (no longer on the market), Wymox (no longer on the market)
Quick facts
Drug class
Amoxicillin is a penicillin-class antibacterial.
Section
Highlights, Indications and Usage (Chartwell RX label)
Source text (exact source wording)
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1)
Rx or otc
Rx (DailyMed Product Type: HUMAN PRESCRIPTION DRUG)
Controlled schedule
Not a controlled substance (no schedule shown in the label)
Forms and strengths
- Tablets: 500 mg, 875 mg (this record's primary form)
- Capsules: 250 mg, 500 mg (this record's primary form)
- Tablets (Chewable): 125 mg, 250 mg (same label; not covered in detail)
- For Oral Suspension: 125 mg/5 mL, 200 mg/5 mL, 250 mg/5 mL, 400 mg/5 mL (same label; not covered in detail)
Generic available
Value
yes
Source
DailyMed Chartwell RX label, Marketing Category ANDA, ANDA065056 (tablets 500 mg)
Common use one line
Antibiotic for bacterial infections of the ear, nose, throat, urinary tract, skin and lower airways; also used with other medicines for H. pylori.
What it is used for
Amoxicillin treats infections caused by certain bacteria in the ear, nose and throat, the genitourinary tract, the skin and the lower respiratory tract. In adults only, it is also used with other medicines for H. pylori infection and duodenal ulcer disease. It should be used only for infections that are proven or strongly suspected to be caused by bacteria.
Section
1 INDICATIONS AND USAGE
Medlineplus section
Why is this medication prescribed?
Source text (exact source wording)
Adults and Pediatric Patients
Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.
Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Adult Patients only
Helicobacter pylori Infection and Duodenal Ulcer Disease:
Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole:
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcusspecies. (α- and β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae.
Infections of the Genitourinary Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Escherichia coli, Proteus mirabilis, or Enterococcus faecalis.
Infections of the Skin and Skin Structure: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), Staphylococcus spp., or E. coli.
Infections of the Lower Respiratory Tract: Amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are indicated in the treatment of infections due to susceptible (ONLY β-lactamase-negative) isolates of Streptococcus spp. (α- and β-hemolytic isolates only), S. pneumoniae, Staphylococcus spp., or H. influenzae.
Adult Patients only
Helicobacter pylori Infection and Duodenal Ulcer Disease:
Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole: Amoxicillin, in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori.
Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Dual therapy for H. pylori with lansoprazole:
Amoxicillin, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.
Usage
To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and other antibacterial drugs, amoxicillin should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Medlineplus source text (exact source wording)
Amoxicillin is used to
treat certain infections caused by bacteria, such as pneumonia, skin, and urinary tract infections
eliminate H. pylori, a bacteria that causes ulcers in combination with other medications
Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria.
Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
treat certain infections caused by bacteria, such as pneumonia, skin, and urinary tract infections
eliminate H. pylori, a bacteria that causes ulcers in combination with other medications
Amoxicillin is in a class of medications called penicillin-like antibiotics. It works by stopping the growth of bacteria.
Antibiotics such as amoxicillin will not work for colds, flu, and other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
How it works
Amoxicillin works like penicillin. It blocks the building of the bacteria's cell wall while they are multiplying, which kills them.
Section
12.4 Microbiology (12.1 Mechanism of Action only says: Amoxicillin is an antibacterial drug [see Microbiology (12.4)] .)
Source text (exact source wording)
Mechanism of Action
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Amoxicillin is similar to penicillin in its bactericidal action against susceptible bacteria during the stage of active multiplication. It acts through the inhibition of cell wall biosynthesis that leads to the death of the bacteria.
Dosage: adults
Take amoxicillin at the start of a meal to lessen stomach upset. For adults with mild or moderate ear, nose, throat, skin or urinary infections, the label lists 500 mg every 12 hours or 250 mg every 8 hours. For severe infections of those types, and for lower respiratory tract infections, it lists 875 mg every 12 hours or 500 mg every 8 hours. Treatment continues for a minimum of 48 to 72 hours beyond the time the patient has no symptoms. Strep (Streptococcus pyogenes) infections need at least 10 days of treatment. Your prescriber chooses the dose for you.
Section
2.1, 2.2 (Table 1), 2.4; Highlights: In Adults, 750 to 1750 mg/day in divided doses every 8 to 12 hours.
Source text (exact source wording)
2.1 Important Administration Instructions
To minimize the potential for gastrointestinal intolerance, amoxicillin should be taken at the start of a meal.
2.2 Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older
Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract: Mild/Moderate: Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg: 500 mg every 12 hours or 250 mg every 8 hours. Severe: 875 mg every 12 hours or 500 mg every 8 hours.
Lower Respiratory Tract: Mild/Moderate or Severe: 875 mg every 12 hours or 500 mg every 8 hours.
a Dosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
(Table 1 above was flattened from the label's table layout; row and column content is as shown in the label.)
2.4 Dosage for H. pyloriInfection in Adults
Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
To minimize the potential for gastrointestinal intolerance, amoxicillin should be taken at the start of a meal.
2.2 Dosage for Adults and Pediatric Patients Aged 3 Months (12 weeks) and Older
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
In some infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Table 1. Dosage Recommendations for Adult and Pediatric Patients Aged 3 Months (12 weeks) and Older
Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract: Mild/Moderate: Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg: 500 mg every 12 hours or 250 mg every 8 hours. Severe: 875 mg every 12 hours or 500 mg every 8 hours.
Lower Respiratory Tract: Mild/Moderate or Severe: 875 mg every 12 hours or 500 mg every 8 hours.
a Dosage for infections caused by bacteria that are intermediate in their susceptibility to amoxicillin should follow the recommendations for severe infections.
(Table 1 above was flattened from the label's table layout; row and column content is as shown in the label.)
2.4 Dosage for H. pyloriInfection in Adults
Triple therapy: The recommended adult oral dose is 1 gram amoxicillin, 500 mg clarithromycin, and 30 mg lansoprazole, all given twice daily (every 12 hours) for 14 days.
Dual therapy: The recommended adult oral dose is 1 gram amoxicillin and 30 mg lansoprazole, each given three times daily (every 8 hours) for 14 days.
Please refer to clarithromycin and lansoprazole full prescribing information.
Dosage: children
For children aged 3 months and older who weigh less than 40 kg, the label gives doses by body weight per day, split into doses every 12 hours or every 8 hours. For mild or moderate infections the label lists 25 mg/kg/day divided every 12 hours or 20 mg/kg/day divided every 8 hours; for severe infections and lower respiratory tract infections it lists 45 mg/kg/day divided every 12 hours or 40 mg/kg/day divided every 8 hours. For babies younger than 12 weeks (3 months), the recommended upper dose is 30 mg/kg/day divided every 12 hours. Safety and effectiveness for H. pylori have not been established in children.
Section
2.2 (Table 1), 2.3, 8.4
Source text (exact source wording)
Table 1 (children under 40 kg, aged 3 months and older): Ear/Nose/Throat, Skin/Skin Structure, Genitourinary Tract, Mild/Moderate: 25 mg/kg/day in divided doses every 12 hours or 20 mg/kg/day in divided doses every 8 hours. Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours. Lower Respiratory Tract, Mild/Moderate or Severe: 45 mg/kg/day in divided doses every 12 hours or 40 mg/kg/day in divided doses every 8 hours.
2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)
It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
8.4 Pediatric Use
The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients.
The safety and effectiveness of amoxicillin for the treatment of H. Pylori infection have not been established in pediatric patients.
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3)] .
2.3 Dosage in Pediatric Patients Aged Less than 12 Weeks (3 months)
It is recommended that there be at least 10 days’ treatment for any infection caused by Streptococcus pyogenes to prevent the occurrence of acute rheumatic fever.
Due to incompletely developed renal function affecting elimination of amoxicillin in this age group, the recommended upper dose of amoxicillin is 30 mg/kg/day divided every 12 hours. There are currently no dosing recommendations for pediatric patients with impaired renal function.
Treatment should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic, or evidence of bacterial eradication has been obtained.
8.4 Pediatric Use
The safety and effectiveness of amoxicillin for the treatment of upper respiratory tract infections, and infections of the genitourinary tract, skin and skin structure and lower respiratory tract have been established in pediatric patients.
The safety and effectiveness of amoxicillin for the treatment of H. Pylori infection have not been established in pediatric patients.
Because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed. Dosing of amoxicillin should be modified in pediatric patients 12 weeks or younger (3 months or younger) [see Dosage and Administration (2.3)] .
Dosage adjustments
Kidney
People with kidney problems usually do not need a lower dose unless the problem is severe. If the glomerular filtration rate (GFR) is less than 30 mL/min, the 875 mg dose should not be used. For GFR 10 to 30 mL/min the label lists 500 mg or 250 mg every 12 hours, and for GFR less than 10 mL/min it lists 500 mg or 250 mg every 24 hours, depending on how serious the infection is. People on hemodialysis get an additional dose during and at the end of dialysis.
Section
2.5 (Table 2), 8.6
Source text (exact source wording)
2.5 Dosage in Renal Impairment for Adults and Pediatric Patients Aged 3 Months and Older and Weight Greater than 40 kg
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of less than 30 mL/min should NOT receive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2.
Table 2. Dosing in Patients with Severe Renal Impairment
GFR 10 to 30 mL/min: 500 mg or 250 mg every 12 hours, depending on the severity of the infection
GFR less than 10 mL/min: 500 mg or 250 mg every 24 hours, depending on severity of the infection
Hemodialysis: 500 mg or 250 mg every 24 hours, depending on severity of the infection. Administer an additional dose both during and at the end of dialysis
8.6 Dosing in Renal Impairment
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment (2.5)for specific recommendations in patients with renal impairment.
Patients with impaired renal function do not generally require a reduction in dose unless the impairment is severe. Renal impairment patients with a glomerular filtration rate of less than 30 mL/min should NOT receive the 875 mg dose. See dosage regimens in patients with severe renal impairment provided in Table 2.
Table 2. Dosing in Patients with Severe Renal Impairment
GFR 10 to 30 mL/min: 500 mg or 250 mg every 12 hours, depending on the severity of the infection
GFR less than 10 mL/min: 500 mg or 250 mg every 24 hours, depending on severity of the infection
Hemodialysis: 500 mg or 250 mg every 24 hours, depending on severity of the infection. Administer an additional dose both during and at the end of dialysis
8.6 Dosing in Renal Impairment
Amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (GFR less than 30 mL/min). See Dosing in Renal Impairment (2.5)for specific recommendations in patients with renal impairment.
Elderly
Studies did not find differences in response between people aged 65 and over and younger people, but some older people may be more sensitive. Because older people are more likely to have reduced kidney function, the dose should be chosen with care and kidney function may be monitored.
Section
8.5 Geriatric Use
Source text (exact source wording)
8.5 Geriatric Use
An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
An analysis of clinical studies of amoxicillin was conducted to determine whether subjects aged 65 and over respond differently from younger subjects. These analyses have not identified differences in responses between the elderly and younger patients, but a greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
Missed dose
Take the missed dose as soon as you remember it. If it is almost time for the next dose, skip the missed dose and go back to your regular schedule. Do not take a double dose.
Source text (exact source wording)
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.
Overdose
In an overdose, call poison control at 1-800-222-1222. Overdose can harm the kidneys, and crystals can form in the urine. Symptoms may include cloudy or bloody urine and decreased urination. Call 911 if the person has collapsed, had a seizure, has trouble breathing, or can't be awakened.
Section
10 OVERDOSAGE
Source text (exact source wording)
10 OVERDOSAGE
In case of overdosage, discontinue amoxicillin, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
In case of overdosage, discontinue amoxicillin, treat symptomatically, and institute supportive measures as required. A prospective study of 51 pediatric patients at a poison-control center suggested that overdosages of less than 250 mg/kg of amoxicillin are not associated with significant clinical symptoms.
Interstitial nephritis resulting in oliguric renal failure has been reported in a small number of patients after overdosage with amoxicillin 1.
Crystalluria, in some cases leading to renal failure, has also been reported after amoxicillin overdosage in adult and pediatric patients. In case of overdosage, adequate fluid intake and diuresis should be maintained to reduce the risk of amoxicillin crystalluria.
Renal impairment appears to be reversible with cessation of drug administration. High blood levels may occur more readily in patients with impaired renal function because of decreased renal clearance of amoxicillin. Amoxicillin may be removed from circulation by hemodialysis.
Medlineplus source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.
Symptoms of overdose may include the following:
cloudy or bloody urine
decreased urination
Symptoms of overdose may include the following:
cloudy or bloody urine
decreased urination
Storage
Store at 20° to 25°C (68° to 77°F). Keep out of the reach of children. MedlinePlus adds to keep tablets and capsules away from excess heat and moisture (not in the bathroom). Liquid should be thrown away after 14 days.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING (Chartwell RX label; storage details are labeler-specific). Section 17, Storage and Special Handling Instructions (suspension): It is preferable to refrigerate amoxicillin suspensions, but not required. ... Discard any unused portion of the suspension after 14 days.
Source text (exact source wording)
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Keep this and all medications out of the reach of children.
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
Keep this and all medications out of the reach of children.
Medlineplus source text (exact source wording)
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the capsules and tablets at room temperature and away from excess heat and moisture (not in the bathroom). The liquid medication preferably should be kept in the refrigerator, but it may be stored at room temperature. Do not freeze. Dispose of any unused liquid medication after 14 days.
Boxed warning
NONEContraindications
Do not take amoxicillin if you have had a serious allergic reaction, such as anaphylaxis or Stevens-Johnson syndrome, to amoxicillin or to other beta-lactam antibiotics such as penicillins and cephalosporins.
Section
4 CONTRAINDICATIONS
Source text (exact source wording)
Amoxicillin is contraindicated in patients who have experienced a serious hypersensitivity reaction (e.g., anaphylaxis or Stevens-Johnson syndrome) to amoxicillin or to other β-lactam antibacterial drugs (e.g., penicillins and cephalosporins).
Warnings and precautions
Serious and sometimes fatal allergic reactions have happened with penicillins, including amoxicillin. People with a history of penicillin allergy are more likely to react. Tell your prescriber about past reactions to penicillins, cephalosporins or other allergens. If an allergic reaction happens, amoxicillin should be stopped.
Heading
5.1 Anaphylactic Reactions
Source text (exact source wording)
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. If an allergic reaction occurs, amoxicillin should be discontinued, and appropriate therapy instituted.
Amoxicillin may cause severe skin reactions. If you get a skin rash you should be monitored closely, and amoxicillin should be stopped if the lesions progress.
Heading
5.2 Severe Cutaneous Adverse Reactions
Source text (exact source wording)
Amoxicillin may cause severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP). If patients develop skin rash they should be monitored closely, and amoxicillin discontinued if lesions progress.
Drug-induced enterocolitis syndrome has been reported, mostly in patients 18 years of age or younger. It causes long-lasting vomiting 1 to 4 hours after taking the drug. If it happens, amoxicillin should be stopped.
Heading
5.3 Drug-Induced Enterocolitis Syndrome (DIES)
Source text (exact source wording)
Drug-induced enterocolitis syndrome (DIES) has been reported with amoxicillin use [see Adverse Reactions (6.2)] , with most cases occurring in pediatric patients ≤18 years of age. DIES is a non-IgE mediated hypersensitivity reaction characterized by protracted vomiting occurring 1 to 4 hours after drug ingestion in the absence of skin or respiratory symptoms. DIES may be associated with pallor, lethargy, hypotension, shock, diarrhea within 24 hours after ingesting amoxicillin, and leukocytosis with neutrophilia. If DIES occurs, discontinue amoxicillin and institute appropriate therapy.
Nearly all antibiotics, including amoxicillin, can cause C. difficile-associated diarrhea, from mild diarrhea to fatal colitis. It can happen even over 2 months after the antibiotic.
Heading
5.4 Clostridioides difficile-Associated Diarrhea (CDAD)
Source text (exact source wording)
Clostridioides difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including amoxicillin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
Taking amoxicillin without a proven or strongly suspected bacterial infection is unlikely to help and raises the risk of drug-resistant bacteria.
Heading
5.5 Development of Drug-Resistant Bacteria
Source text (exact source wording)
Prescribing amoxicillin in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
A high percentage of people with mononucleosis who take amoxicillin develop a skin rash, so amoxicillin should not be given to them.
Heading
5.6 Skin Rash in Patients with Mononucleosis
Source text (exact source wording)
A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash. Thus, amoxicillin should not be administered to patients with mononucleosis.
Pregnancy and breastfeeding
Animal studies showed no harm to the fetus, but there are no adequate and well-controlled studies in pregnant women, so amoxicillin should be used during pregnancy only if clearly needed. Penicillins are excreted in human milk and may lead to sensitization of infants, so caution is advised for nursing women. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Section
8.1, 8.2, 8.3
Source text (exact source wording)
8.1 Pregnancy
Teratogenic Effects:
Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
8.2 Labor and Delivery
Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
8.3 Nursing Mothers
Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Teratogenic Effects:
Reproduction studies have been performed in mice and rats at doses up to 2000 mg/kg (3 and 6 times the 3 g human dose, based on body surface area). There was no evidence of harm to the fetus due to amoxicillin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, amoxicillin should be used during pregnancy only if clearly needed.
8.2 Labor and Delivery
Oral ampicillin is poorly absorbed during labor. It is not known whether use of amoxicillin in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention.
8.3 Nursing Mothers
Penicillins have been shown to be excreted in human milk. Amoxicillin use by nursing mothers may lead to sensitization of infants. Caution should be exercised when amoxicillin is administered to a nursing woman.
Medlineplus source text (exact source wording)
tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while taking amoxicillin, call your doctor.
Side effects
Common
The most common side effects (greater than 1%) in clinical trials were diarrhea, rash, vomiting and nausea.
Threshold
greater than 1%
Section
6.1 Clinical Trials Experience
Source text (exact source wording)
The most common adverse reactions (greater than 1%) observed in clinical trials of amoxicillin capsules, amoxicillin tablets or for oral suspension were diarrhea, rash, vomiting, and nausea.
Less common
In H. pylori combination therapy, the most frequently reported events were diarrhea (7%), headache (6%) and taste perversion (5%) with triple therapy, and diarrhea (8%) and headache (7%) with dual therapy.
Section
6.1 Clinical Trials Experience (H. pylori regimens). The label has no placebo-controlled adverse reaction table.
Source text (exact source wording)
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.
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.
Serious
Serious problems reported include severe allergic reactions, severe skin reactions, severe diarrhea or colitis, liver problems, blood problems and seizures (convulsions). MedlinePlus says to stop amoxicillin and call your doctor right away for rash, itching or hives, skin blisters or peeling, wheezing or trouble swallowing or breathing, swelling of the face, throat, tongue, lips or eyes, prolonged vomiting, or severe watery or bloody diarrhea.
Label section
6.2 Postmarketing Experience (plus Warnings 5.1 to 5.4)
Medlineplus section
What side effects can this medication cause?
Label source text (exact source wording)
6.2 Postmarketing Experience ... Infections and Infestations: Mucocutaneous candidiasis.
Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.4)] .
Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)] .
Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.
Liver: A moderate rise in AST and/or ALT 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 been reported [see Overdosage (10)] .
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. 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, aseptic meningitis, and/or dizziness 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.
Gastrointestinal: Drug-induced enterocolitis syndrome (DIES), black hairy tongue, and hemorrhagic/pseudomembranous colitis. Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.4)] .
Immune: Hypersensitivity reactions, anaphylactic/anaphylactoid reactions (including shock), angioedema, serum sickness-like reactions (urticaria or skin rash accompanied by arthritis, arthralgia, myalgia, and frequently fever), hypersensitivity vasculitis [see Warnings and Precautions (5.1)] .
Skin and Appendages: Rashes, pruritus, urticaria, erythema multiforme, SJS, TEN, DRESS, AGEP, exfoliative dermatitis, and linear IgA bullous dermatosis.
Liver: A moderate rise in AST and/or ALT 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 been reported [see Overdosage (10)] .
Hemic and Lymphatic Systems: Anemia, including hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported. 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, aseptic meningitis, and/or dizziness 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.
Medlineplus source text (exact source wording)
Some side effects can be serious. If you experience any of these symptoms, stop taking amoxicillin and call your doctor immediately or get emergency medical treatment:
rash, itching, hives
skin blisters or peeling
wheezing; difficulty swallowing or breathing; swelling of the face, throat, tongue, lips, and eye
prolonged vomiting (occurring 1 to 4 hours after taking amoxicillin), diarrhea, extreme tiredness, and paleness that may occur within 24 hours of taking amoxicillin
severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
rash, itching, hives
skin blisters or peeling
wheezing; difficulty swallowing or breathing; swelling of the face, throat, tongue, lips, and eye
prolonged vomiting (occurring 1 to 4 hours after taking amoxicillin), diarrhea, extreme tiredness, and paleness that may occur within 24 hours of taking amoxicillin
severe diarrhea (watery or bloody stools) that may occur with or without fever and stomach cramps (may occur up to 2 months or more after your treatment)
Medlineplus mild
Section
MedlinePlus, What side effects can this medication cause?
Source text (exact source wording)
Amoxicillin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
nausea, vomiting, diarrhea
temporary discoloration (yellow, brown, or gray color) of your teeth
nausea, vomiting, diarrhea
temporary discoloration (yellow, brown, or gray color) of your teeth
Interactions
Drugs
Probenecid can raise and prolong amoxicillin blood levels. The label highlights say coadministration with probenecid is not recommended.
Name
Probenecid
Section
7.1 Probenecid
Source text (exact source wording)
Probenecid decreases the renal tubular secretion of amoxicillin. Concurrent use of amoxicillin and probenecid may result in increased and prolonged blood levels of amoxicillin.
Blood-thinner tests (prothrombin time, INR) can become abnormally prolonged. Appropriate monitoring is needed, and the blood thinner dose may need adjusting.
Name
Oral anticoagulants
Section
7.2 Oral Anticoagulants
Source text (exact source wording)
Abnormal prolongation of prothrombin time (increased international normalized ratio [INR]) has been reported in patients receiving amoxicillin and oral anticoagulants.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Appropriate monitoring should be undertaken when anticoagulants are prescribed concurrently. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation.
Taking allopurinol with amoxicillin increases the incidence of rashes compared with amoxicillin alone.
Name
Allopurinol
Section
7.3 Allopurinol
Source text (exact source wording)
The concurrent administration of allopurinol and amoxicillin increases the incidence of rashes in patients receiving both drugs as compared to patients receiving amoxicillin alone. It is not known whether this potentiation of rashes is due to allopurinol or the hyperuricemia present in these patients.
Amoxicillin may reduce how well combined estrogen/progesterone birth control pills work.
Name
Oral contraceptives
Section
7.4 Oral Contraceptives
Source text (exact source wording)
Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.
Chloramphenicol, macrolides, sulfonamides and tetracyclines may interfere with penicillin's germ-killing effect. This was shown in the lab; the clinical significance is not well documented.
Name
Other antibacterials (chloramphenicol, macrolides, sulfonamides, tetracyclines)
Section
7.5 Other Antibacterials
Source text (exact source wording)
Chloramphenicol, macrolides, sulfonamides, and tetracyclines may interfere with the bactericidal effects of penicillin. This has been demonstrated in vitro; however, the clinical significance of this interaction is not well documented.
Food and alcohol
Take amoxicillin at the start of a meal to lessen stomach upset.
Name
Food
Section
2.1 Important Administration Instructions
Source text (exact source wording)
To minimize the potential for gastrointestinal intolerance, amoxicillin should be taken at the start of a meal.
Name
Alcohol
Other
Amoxicillin may cause false-positive urine sugar results with CLINITEST, Benedict's Solution or Fehling's Solution. Tests based on enzymatic glucose oxidase (such as CLINISTIX) are recommended.
Name
Urine glucose tests
Section
7.6 Effects on Laboratory Tests
Source text (exact source wording)
High urine concentrations of ampicillin may result in false-positive reactions when testing for the presence of glucose in urine using CLINITEST ®, Benedict’s Solution, or Fehling’s Solution. Since this effect may also occur with amoxicillin, it is recommended that glucose tests based on enzymatic glucose oxidase reactions (such as CLINISTIX ®) be used.
Patient tips
Take amoxicillin exactly as directed and finish the whole prescription, even if you feel better, because skipping doses or stopping early may leave the infection not completely treated and may let bacteria become resistant. It may be taken every 8 hours or every 12 hours depending on the dose prescribed. Antibiotics do not treat viral infections such as the common cold. Stop taking it and report skin rash or any sign of allergic reaction right away. If watery or bloody stools develop, even as late as 2 or more months after the last dose, contact your doctor as soon as possible. Amoxicillin may decrease the effectiveness of hormonal contraceptives, so another birth control method is needed.
Label
Section
17 PATIENT COUNSELING INFORMATION (the label has no separate Patient Information leaflet in the printable page)
Source text (exact source wording)
17 PATIENT COUNSELING INFORMATION
Administration Instructions
Advise patients that amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
Allergic Reactions
Counsel patients that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.
Severe Cutaneous Adverse Reactions (SCAR)
Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.2)] .
Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
Antibacterial Resistance
Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat or prevent bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future.
Administration Instructions
Advise patients that amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules may be taken every 8 hours or every 12 hours, depending on the dose prescribed.
Allergic Reactions
Counsel patients that amoxicillin contains a penicillin class drug product that can cause allergic reactions in some individuals.
Severe Cutaneous Adverse Reactions (SCAR)
Advise patients about the signs and symptoms of serious skin manifestations. Instruct patients to stop taking amoxicillin immediately and promptly report the first signs or symptoms of skin rash, mucosal lesions, or any other sign of hypersensitivity [see Warnings and Precautions (5.2)] .
Diarrhea
Counsel patients that diarrhea is a common problem caused by antibacterial drugs which usually ends when the antibacterial drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as 2 or more months after having taken their last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
Antibacterial Resistance
Patients should be counseled that antibacterial drugs, including amoxicillin, should only be used to treat or prevent bacterial infections. Antibacterial drugs do not treat viral infections (e.g., the common cold). When amoxicillin tablets, amoxicillin for oral suspension, amoxicillin tablets (chewable), and amoxicillin capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may: (1) decrease the effectiveness of the immediate treatment, and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by amoxicillin or other antibacterial drugs in the future.
Medlineplus
Section
MedlinePlus a685001: How should this medicine be used? / What special precautions should I follow? / dietary instructions
Source text (exact source wording)
Take amoxicillin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Take amoxicillin until you finish the prescription, even if you feel better. If you stop taking amoxicillin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
you should know that amoxicillin may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking amoxicillin.
tell your doctor if you have mononucleosis (a virus; also called 'mono') and if you have or have ever had kidney or liver disease, allergies, asthma, hay fever, or hives.
Unless your doctor tells you otherwise, continue your normal diet.
Take amoxicillin until you finish the prescription, even if you feel better. If you stop taking amoxicillin too soon or skip doses, your infection may not be completely treated and the bacteria may become resistant to antibiotics.
you should know that amoxicillin may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, and injections). You will need to use another method of contraception to prevent pregnancy while taking amoxicillin.
tell your doctor if you have mononucleosis (a virus; also called 'mono') and if you have or have ever had kidney or liver disease, allergies, asthma, hay fever, or hives.
Unless your doctor tells you otherwise, continue your normal diet.
Alternatives
Class statement
Source text (exact source wording)
Amoxicillin is a penicillin-class antibacterial indicated for treatment of infections due to susceptible strains of designated microorganisms. ( 1)
Recommendation
none (not ranked)
Frequently asked questions
Question
What is amoxicillin used for?
Answer
Amoxicillin treats infections caused by certain bacteria in the ear, nose and throat, the genitourinary tract, the skin and the lower respiratory tract. In adults it is also used with other medicines for H. pylori infection and duodenal ulcer disease. It does not work for colds, flu and other viral infections.
Source section
1 INDICATIONS AND USAGE; MedlinePlus Why is this medication prescribed?
Source
DailyMed Chartwell RX label; MedlinePlus a685001
Question
Should I take amoxicillin with food?
Answer
The label says to take amoxicillin at the start of a meal to lessen stomach upset. MedlinePlus says it may be taken with food to prevent stomach upset and that you should continue your normal diet unless your doctor says otherwise.
Source section
2.1 Important Administration Instructions
Source
DailyMed Chartwell RX label; MedlinePlus a685001
Question
What should I do if I miss a dose of amoxicillin?
Answer
Take the missed dose as soon as you remember it. If it is almost time for the next dose, skip the missed dose and continue your regular schedule. Do not take a double dose.
Source section
What should I do if I forget a dose?
Source
MedlinePlus a685001
Question
What are the most common side effects of amoxicillin?
Answer
In clinical trials the most common side effects (greater than 1%) were diarrhea, rash, vomiting and nausea.
Source section
6.1 Clinical Trials Experience
Source
DailyMed Chartwell RX label
Question
Can I take amoxicillin if I am pregnant or breastfeeding?
Answer
The label says amoxicillin should be used during pregnancy only if clearly needed, because there are no adequate and well-controlled studies in pregnant women. Penicillins are excreted in human milk and may lead to sensitization of infants, so caution is advised. Tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.
Source section
8.1 Pregnancy; 8.3 Nursing Mothers
Source
DailyMed Chartwell RX label; MedlinePlus a685001
Question
What medicines should not be combined with amoxicillin?
Answer
The label lists probenecid, oral anticoagulants (blood thinners), allopurinol and oral contraceptives. Probenecid can raise and prolong amoxicillin blood levels. Allopurinol increases the incidence of rashes. Amoxicillin may reduce the efficacy of combined oral contraceptives. Tell your doctor and pharmacist about everything you take.
Source section
7 DRUG INTERACTIONS
Source
DailyMed Chartwell RX label
Question
Does amoxicillin affect birth control pills?
Answer
Amoxicillin may affect the intestinal flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives. MedlinePlus advises using another method of contraception while taking amoxicillin.
Source section
7.4 Oral Contraceptives
Source
DailyMed Chartwell RX label; MedlinePlus a685001
Question
Should I stop amoxicillin when I feel better?
Answer
No. Although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course may decrease the effectiveness of the treatment and increase the likelihood that bacteria will become resistant.
Source section
17 PATIENT COUNSELING INFORMATION, Antibacterial Resistance
Source
DailyMed Chartwell RX label; MedlinePlus a685001
Sources
- DailyMed amoxicillin label (primary)
Set id: b07b5ac4-253e-4c83-91c3-3fdc46e91a0f · Label effective or revised date: Revised: 9/2026 · Dailymed version date: Updated September 4, 2026 (shown on drugInfo page); DailyMed list API published_date Oct 09, 2026 · Fetched at: 2026-11-02 · Sections used: 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 16, 17 - Alternate label 1
Set id: 110ba6b1-f175-48a1-8e30-616c02212538 · Label effective or revised date: Revised: 6/2026 (read from Highlights; body not opened) · Fetched at: 2026-11-02 - Alternate label 2
Set id: 4fb7837e-964c-4d38-a3a5-b384b1bd6e08 · Label effective or revised date: Revised: 3/2026 (read from Highlights; body not opened) · Fetched at: 2026-11-02 - Other label checked, not chosen
Set id: 13bd4214-9b7f-425b-af5f-fc1ddc678230 · Label effective or revised date: Revised: 2/2024 - MedlinePlus Amoxicillin
Set id: n/a · Label effective or revised date: Last Revised - 05/15/2026 · Fetched at: 2026-11-02 · Sections used: all patient sections - Drugs@FDA
- openFDA
Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug