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Unasyn Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Unasyn (ampicillin sodium/sulbactam sodium) is a combination antibiotic indicated for the treatment of infections due to susceptible strains of microorganisms. Common side effects of Unasyn include:
- sore throat,
- body aches,
- stomach pain,
- vaginal itching or discharge,
- swollen/black/"hairy" tongue,
- thrush (white patches inside your mouth or throat), or
- pain, swelling, or irritation where the needle is placed.
Unasyn is administered orally in the form of tablets. Unasyn may interact with allopurinol, probenecid, or other antibiotics. Tell your doctor all medications and supplements you use. Safe use of Unasyn during pregnancy and breastfeeding has not been established; therefore, the potential benefits must be weighed against the possible hazards.
Our Unasyn 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.
Unasyn 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 any of these serious side effects:
- fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
- diarrhea that is watery or bloody; or
- fever, chills, body aches, flu symptoms.
Less serious side effects may include:
- nausea, vomiting, stomach pain, bloating, gas;
- vaginal itching or discharge;
- swollen, black, or "hairy" tongue;
- thrush (white patches or inside your mouth or throat); or
- pain, swelling, or other irritation where the needle is placed.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Unasyn (Ampicillin and Sulbactam)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Unasyn Overview - Patient Information: Side Effects
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 right away if you have any serious side effects, including: pain/swelling at injection site (if this drug is injected into a vein), chest pain, difficult/painful urination, easy bruising/bleeding, signs of liver disease (such as persistent nausea/vomiting, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), new signs of infection (such as fever, persistent sore throat), change in the amount of urine.
This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a 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. 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 rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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, get medical help right away 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 Unasyn (Ampicillin and Sulbactam)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Unasyn FDA Prescribing Information: Side Effects
UNASYN is generally well tolerated. The following adverse reactions have been reported in clinical trials.
Local Adverse Reactions
Pain at IM injection site – 16%
Pain at IV injection site – 3%
Thrombophlebitis – 3%
Phlebitis – 1.2%
Systemic Adverse Reactions
The most frequently reported adverse reactions were diarrhea in 3% of the patients and rash in less than 2% of the patients.
Additional systemic reactions reported in less than 1% of the patients were: itching, nausea, vomiting, candidiasis, fatigue, malaise, headache, chest pain, flatulence, abdominal distension, glossitis, urine retention, dysuria, edema, facial swelling, erythema, chills, tightness in throat, substernal pain, epistaxis and mucosal bleeding.
Available safety data for pediatric patients treated with UNASYN demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving UNASYN.
Adverse Laboratory Changes
Adverse laboratory changes without regard to drug relationship that were reported during clinical trials were:
Blood Chemistry: Decreased serum albumin and total proteins.
Renal: Increased BUN and creatinine.
Urinalysis: Presence of RBC's and hyaline casts in urine.
In addition to adverse reactions reported from clinical trials, the following have been identified during postmarketing use of UNASYN or other products containing ampicillin. 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, or potential causal connection to UNASYN.
Blood And Lymphatic System Disorders
Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis have been reported. These reactions are usually reversible on discontinuation of therapy and are believed to be hypersensitivity phenomena. Some individuals have developed positive direct Coombs Tests during treatment with UNASYN, as with other beta-lactam antibacterials.
Cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, gastritis, stomatitis, black "hairy" tongue and Clostridium difficile associated diarrhea (see CONTRAINDICATIONS and WARNINGS).
General Disorders And Administration Site Conditions
Injection site reaction
Immune System Disorders
Serious and fatal hypersensitivity (anaphylactic) reactions (See WARNINGS).
Nervous System Disorders
Renal And Urinary Disorders
Skin And Subcutaneous Tissue Disorders
Toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalized exanthematous pustulosis (AGEP), urticaria, erythema multiforme, and exfoliative dermatitis (see CONTRAINDICATIONS and WARNINGS).
Read the entire FDA prescribing information for Unasyn (Ampicillin and Sulbactam)
Additional Unasyn Information
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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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