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Unasyn (Ampicillin Sodium / Sulbactam Sodium) - Side Effects and Adverse Reactions



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.

The following adverse reactions have been identified in post-marketing reports. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and Lymphatic System Disorders: Hemolytic anemia, thrombocytopenic purpura

General Disorders and Administration Site Conditions: Injection site reaction

Hepatobiliary Disorders: Hepatitis cholestatic, cholestasis, hyperbilirubinemia, jaundice, and hepatic function abnormal

Nervous System Disorders: Convulsion

Renal and Urinary Disorders: Tubulointerstitial nephritis

Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens-Johnson syndrome, and acute generalised exanthematous pustulosis (AGEP)

The following adverse reactions have been reported with ampicillin-class antibiotics and can also occur with UNASYN.

Gastrointestinal Disorders

Gastritis, stomatitis, black "hairy" tongue and enterocolitis. Onset of pseudomembranous colitis symptoms may occur during or after antibiotic treatment. (see WARNINGS section).

Skin and Subcutaneous Tissue Disorders

Urticaria, erythema multiforme, and an occasional case of exfoliative dermatitis have been reported. These reactions may be controlled with antihistamines and, if necessary, systemic corticosteroids. Whenever such reactions occur, the drug should be discontinued, unless the opinion of the physician dictates otherwise.

Immune System Disorders

Serious and occasional fatal hypersensitivity (anaphylactic) reactions can occur with a penicillin including UNASYN. (See WARNINGS section).

Blood and Lymphatic System Disorders

In addition to the adverse laboratory changes listed above, agranulocytosis has been reported during therapy with penicillins including UNASYN. All of 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 antibiotics.


Below is a sample of reports where side effects / adverse reactions may be related to Unasyn. The information is not vetted and should not be considered as verified clinical evidence.

Possible Unasyn side effects / adverse reactions in 78 year old male

Reported by a physician from Italy on 2011-10-05

Patient: 78 year old male

Reactions: Purpura, Vasculitis, Toxic Skin Eruption

Suspect drug(s):

Other drugs received by patient: Spiriva; Amiodarone HCL; Lento-Kalium; Mircera; Aspirin; Pantoprazole Sodium; Nitroglycerin; Plavix; Furosemide

Possible Unasyn side effects / adverse reactions in 84 year old male

Reported by a physician from Japan on 2011-10-07

Patient: 84 year old male

Reactions: Blood Bilirubin Increased, Jaundice, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Liver Disorder

Adverse event resulted in: hospitalization

Suspect drug(s):
Doripenem Monohydrate
    Indication: Pneumonia
    Start date: 2011-09-02
    End date: 2011-09-08

    Indication: Pneumonia
    Start date: 2011-09-08
    End date: 2011-09-15

    Indication: Pneumonia
    Start date: 2011-08-31
    End date: 2011-09-01

Possible Unasyn side effects / adverse reactions in 60 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-11

Patient: 60 year old female weighing 58.5 kg (128.7 pounds)

Reactions: Abdominal Pain Lower, Back Pain, Nausea, Pain, Post Procedural Complication, Drug Intolerance, Urinary Tract Infection, Clostridium Difficile Colitis, Constipation, Gastritis, Dysuria, Urinary Retention

Adverse event resulted in: hospitalization

Suspect drug(s):
Augmentin '875'
    Dosage: 2 in 1 d, oral
    Administration route: Oral
    Indication: Urinary Tract Infection
    Start date: 2011-08-04
    End date: 2011-08-07

Blinded Therapy (Blinded)
    Dosage: oral
    Administration route: Oral
    Indication: Osteoarthritis
    Start date: 2011-07-15
    End date: 2011-08-02

    Dosage: 3 gm, 1 in 6 hr, intravenous
    Indication: Urinary Tract Infection
    Start date: 2011-08-03
    End date: 2011-08-04

Other drugs received by patient: Norco (Hydrocodone Bitartrate + Paracetamol) (Procet /01554201/); Colecalciferol (Colecalciferol); Levoxyl; Estradiol; Milk OF Magnesia TAB; Etodolac; Colace (Docusate Sodium); Aspirin; Vytorin (Ezetimibe+simvastatin) (Inegy); Lisinopril; Omega 3 Plus D3 Fish OIL (Fish Oil); Hexavitamin (Hexavitamin /01719701/); Lutein (Xantofyl); Calcium W/magnesium (Calcium W/magnesium); Lidoderm; Ibuprofen; Macrobid

See index of all Unasyn side effect reports >>

Drug label data at the top of this Page last updated: 2013-12-09

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