Principen Side Effects

Generic Name: ampicillin,ampicillin sodium and sulbactam sodium

Please note - some side effects for Principen may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Principen - for the Consumer

Principen

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 Principen:

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 .

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

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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