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Principen

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Principen

Principen Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Principen (ampicillin) is used to treat many different types of infections caused by bacteria, such as ear infections, bladder infections, pneumonia, gonorrhea, and E. coli or salmonella infection. It is an antibiotic in the penicillin group of drugs. This medication is available in generic form. Common side effects include nausea, vomiting, diarrhea, or mouth/tongue sores.

The usual oral dose range of Principen for most infections is 250 to 500 mg 4 times daily for 7-14 days. To treat gonorrhea, a single 3.5 g dose is administered along with probenecid. Principen may interact with allopurinol, methotrexate, sulfa drugs, or tetracycline antibiotics. Tell your doctor all medications you are taking. Principen should be used only when prescribed during pregnancy. This medication passes into breast milk. Consult your doctor before breast-feeding.

Our Principen (ampicillin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Principen in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
  • diarrhea that is watery or bloody;
  • fever, chills, body aches, flu symptoms;
  • easy bruising or bleeding, unusual weakness;
  • urinating less than usual or not at all;
  • agitation, confusion, unusual thoughts or behavior; or
  • seizure (black-out or convulsions).

Less serious side effects may include

  • nausea, vomiting, stomach pain;
  • vaginal itching or discharge;
  • headache;
  • swollen, black, or "hairy" tongue; or
  • thrush (white patches or inside your mouth or throat).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Principen (Ampicillin) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Principen Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, diarrhea, or mouth/tongue sores may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: dark urine, persistent nausea or vomiting, stomach/abdominal pain, yellowing eyes or skin, easy bruising or bleeding, persistent sore throat or fever.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new vaginal yeast infection (oral or vaginal fungal infection). Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge or other new symptoms.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Ampicillin can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, seek immediate medical attention if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Principen (Ampicillin)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Principen FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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 penicillin 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: glositis, stamatitis, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea. These reactions are usually associated with oral dosage forms of the drugs.

Hypersensitivity Reactions: An erythematous, mildly pruritic, maculopapular skin rash has been reported fairly frequently. The rash, which usually does not develop within the first week of therapy, may cover the entire body including the soles, palms, and oral mucosa. The eruption usually disappears in three to seven days.

Other hypersensitivity reactions that have been reported are: skin rash, pruritus, urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis. Anaphylaxis is the most serious reaction experienced and has usually been associated with the parenteral dosage form of the drug

Note: Urticaria, other skin rashes, and serum sickness-like reactions may be controlled by 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 anaphylactoid reactions require emergency measures (see WARNINGS).

Liver: Moderate elevation in serum glutamic oxalaacetic transaminase (SGOT) has been noted, but the significance of this finding is unknown.

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

Other: Other adverse reactions that have been reported with the use at ampicillin are laryngeal stride and high fever. An occasional patient may complain of sore mouth or tongue as with any oral penicillin preparation.

Read the entire FDA prescribing information for Principen (Ampicillin) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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