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.
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)
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)
© Unasyn Patient Information is supplied by Cerner Multum, Inc. and Unasyn Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.