Ampicillin Side Effects

Please note - some side effects for Ampicillin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ampicillin - for the Consumer

Ampicillin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ampicillin:

Inflammation and redness of the tongue; irritation of mouth or throat; mild diarrhea; nausea; second infection; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; severe diarrhea; stomach pain/cramps; vaginal irritation or discharge.

Ampicillin/Sulbactam

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ampicillin/Sulbactam:

Mild diarrhea; pain, swelling, or redness at injection site.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools or severe diarrhea; chest pain; chills; fever; severe nausea or vomiting; stomach pain or cramps; unusual bruising or bleeding; vaginal irritation or discharge; vein inflammation or tenderness; white patches in mouth.

Ampicillin Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ampicillin Solution:

Black, "hairy" tongue; inflammation and redness of the tongue; mild diarrhea; nausea; second infection; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; chills; fever; itching; muscle pain; pain, redness, or swelling at the injection site; severe diarrhea; stomach pain/cramps; vaginal irritation or discharge.

Ampicillin Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ampicillin Suspension:

Mild diarrhea; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody stools; fever, chills, or sore throat; seizures; severe diarrhea; severe nausea or vomiting; stomach pain or cramps; unusual bruising or bleeding; unusual tiredness or weakness; vaginal irritation or discharge; vein inflammation or tenderness; white patches in mouth.

Ampicillin Side Effects - for the Professional

Ampicillin

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 Ampicillin:

Gastrointestinal

Glossitis, stomatitis, black "hairy" tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. (These reactions are usually associated with oral dosage forms.)

Hypersensitivity Reactions

Skin rashes and urticaria have been reported frequently. A few cases of exfoliative dermatitis and erythema multiforme have been reported. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form.

Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, Ampicillin should be discontinued, unless, in the opinion of the physician, the condition being treated is life-threatening and amenable only to Ampicillin therapy. Serious anaphylactic reactions require the immediate use of epinephrine, oxygen, and intravenous steroids.

Liver– A moderate rise in serum glutamic oxaloacetic transaminase (SGOT) has been noted, particularly in infants, but the significance of this finding is unknown. Mild transitory SGOT elevations have been observed in individuals receiving larger (two to four times) than usual and oft-repeated intramuscular injections. Evidence indicates that glutamic oxaloacetic transaminase (GOT) is released at the site of intramuscular injection of Ampicillin sodium and that the presence of increased amounts of this enzyme in the blood does not necessarily indicate liver involvement.

Hemic and Lymphatic Systems– Anemia, thrombocytopenia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during therapy with the penicillins. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena.

Side Effects by Body System

Hypersensitivity

The eruption that is sometimes observed in ampicillin-treated patients with undiagnosed infectious mononucleosis is characterized by a delayed pruritic maculopapular erythematous rash that generally occurs 5 to 10 days after ampicillin therapy is initiated. It is often more severe and extensive and longer in duration than the typical spontaneous eruption of infectious mononucleosis, but does not necessarily indicate a lifelong allergy to ampicillin or other penicillin derivatives. Although this type of reaction has been described with penicillin and also tetracycline, ampicillin has been implicated most frequently. Therefore, ampicillin may not be suitable in patients suspected of having infectious mononucleosis.

Hypersensitivity reactions have included urticarial rash, erythema multiforme, exfoliative dermatitis, serum sickness-like reactions, edema, hypotension, fever, eosinophilia, dyspnea, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, Stevens-Johnson syndrome, bullous pemphigoid, hypersensitivity myocarditis, toxic epidermal necrolysis, and fixed drug eruptions. Anaphylaxis is rare (up to 0.2%), but is more common in patients receiving parenteral ampicillin therapy. Erythematous eruptions have been reported in patients with infectious mononucleosis who were given ampicillin.

Gastrointestinal

Gastrointestinal side effects have included diarrhea (5% to 20%), nausea, vomiting, anorexia, gastritis, generalized abdominal cramps, oral candidiasis, black hairy tongue, mouth or tongue soreness, glossitis, stomatitis, enterocolitis, and pseudomembranous colitis. Rare cases of pancreatitis have occurred.

Ampicillin-associated diarrhea is usually self-limiting and thought to be related to alterations of intestinal microflora. However, Clostridium difficile toxin diarrhea may occasionally occur and may be indicative of pseudomembranous colitis. If diarrhea is severe, or if the patient has more than 10 loose stools per day, the stools should be tested for Clostridium difficile toxin. Clostridium perfringens type C has also been implicated in an isolated case of ampicillin-related pseudomembranous colitis in an 11-year-old boy.

Transient increases in liver function tests and chronic cholestasis have rarely been associated with ampicillin. Acute pancreatitis has been reported and confirmed by rechallenge with ampicillin in a patient in whom there was no other obvious cause of pancreatitis.

Hematologic

Neutropenia was described in one case report of 3 pediatric patients who received high dosages (150 to 400 mg/kg) of intravenous ampicillin. In all 3 cases, white blood cell and neutrophil counts returned to normal after discontinuation of therapy.

Hematologic side effects have rarely included thrombocytopenia, thrombocytopenic purpura, Henoch Schönlein purpura, red cell aplasia, leukopenia, neutropenia, anemia, eosinophilia and agranulocytosis. These reactions are generally reversible and some may be allergic in nature. Prolongations in activated partial thromboplastin time and bleeding time, and platelet aggregation abnormalities have also been reported. Leukopenia has been reported in 23% of patients with liver disease receiving beta-lactam antibiotics.

Nervous system

Nervous system side effects have rarely included seizures in patients treated with large intravenous doses of ampicillin, headache, and dizziness.

Seizures have been reported in patients with high serum concentrations of ampicillin, although these patients were otherwise very ill. High cerebral spinal fluid (CSF) levels of some penicillins are known to be potentially neurotoxic, and the CSF concentrations of ampicillin rise significantly in meningitis.

Generalized seizures have been described in 2 patients during treatment with ampicillin, although in both cases, there were underlying disease factors that may have predisposed the patients to seizure activity.

Renal

Renal side effects have rarely included crystalluria in patients receiving high dosages of intravenous ampicillin, interstitial nephritis, and glomerulonephritis. The latter two may be associated with hypersensitivity.

Hepatic

Hepatic side effects have included rare cases of hepatitis, cholestasis, and elevated AST (SGOT) and ALT (SGPT). Glutamic oxalacetic transaminase is released at intramuscular injection sites; therefore increased SGOT is not necessarily a hepatic side effect.

Local

Local side effects have rarely included phlebitis after IV administration and pain with IM administration of ampicillin.

Dermatologic

Dermatologic side effects have included rash, maculopapular rash, morbilliform rash, exfoliative dermatitis, erythema multiforme, purpura, urticaria, pruritus, and acute generalized exanthematous pustulosis. Rashes have been reported in patients with infectious mononucleosis and Epstein-Barr virus. Ampicillin has also been associated with a case of reactivation of latent Epstein-Barr virus infection and rash.

HIV/AIDS patients have a significantly higher incidence of rash than other patients.

Genitourinary

Genitourinary side effects have included vaginal candidiasis.

Respiratory

Respiratory side effects have included laryngeal stridor.

Other

Other side effects have included fever.

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