Unasyn Side Effects Center

Last updated on RxList: 3/29/2021
Unasyn Side Effects Center

What Is Unasyn?

Unasyn (ampicillin sodium/sulbactam sodium) is a combination antibiotic indicated for the treatment of infections due to susceptible strains of the designated microorganisms.

What Are Side Effects of Unasyn?

Common side effects of Unasyn include:

  • fever,
  • sore throat,
  • headache,
  • rash,
  • diarrhea,
  • body aches,
  • nausea,
  • vomiting,
  • stomach pain,
  • bloating,
  • gas,
  • vaginal itching or discharge,
  • itching,
  • swollen/black/"hairy" tongue,
  • thrush (white patches inside your mouth or throat), or
  • pain, swelling, or irritation where the needle is placed

Dosage for Unasyn

Unasyn is administered orally in the form of tablets.

What Drugs, Substances, or Supplements Interact with Unasyn?

Unasyn may interact with allopurinol, probenecid, or other antibiotics. Tell your doctor all medications and supplements you use.

Unasyn During Pregnancy and Breastfeeding

Safe use of Unasyn during pregnancy and breastfeeding has not been established; therefore, the potential benefits must be weighed against the possible hazards.

Additional Information

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.

QUESTION

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Unasyn Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

  • severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);
  • thrush (white patches inside your mouth or throat);
  • heart problems--fast heartbeats, chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
  • signs of a new infection--fever, headache, tiredness, ear pain or drainage, eye pain or redness, cough, skin rash, sores or pimples with pus, joint pain, ongoing neck or back pain, diarrhea, pain or burning when you urinate.

Common side effects may include:

  • diarrhea;
  • rash;
  • swollen, black, or "hairy" tongue;
  • vaginal itching or discharge;
  • pain where the medicine was injected.

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.

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Pelvic Pain: What's Causing Your Pelvic Pain? See Slideshow
Unasyn Professional Information

SIDE EFFECTS

Adult Patients

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.

Pediatric Patients

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:

Hepatic: Increased AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH.

Hematologic: Decreased hemoglobin, hematocrit, RBC, WBC, neutrophils, lymphocytes, platelets and increased lymphocytes, monocytes, basophils, eosinophils, and platelets.

Blood Chemistry: Decreased serum albumin and total proteins.

Renal: Increased BUN and creatinine.

Urinalysis: Presence of RBC’s and hyaline casts in urine.

Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following have been identified during post-marketing use of ampicillin sodium/sulbactam sodium 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 ampicillin sodium/sulbactam sodium.

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.

Gastrointestinal Disorders: Abdominal pain, cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function, melena, gastritis, stomatitis, dyspepsia, black “hairy” tongue, and Clostridium difficile associated diarrhea (see CONTRAINDICATIONS and WARNINGS sections).

General Disorders and Administration Site Conditions: Injection site reaction

Immune System Disorders: Serious and fatal hypersensitivity (anaphylactic) reactions (see WARNINGS section).

Nervous System Disorders: Convulsion and dizziness

Renal and Urinary Disorders: Tubulointerstitial nephritis

Respiratory, Thoracic and Mediastinal Disorders: Dyspnea

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, Acute generalized exanthematous pustulosis (AGEP), erythema multiforme, exfoliative dermatitis, and urticaria (see CONTRAINDICATIONS and WARNINGS sections).

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.

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