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

 
 



ADVERSE REACTIONS

Adult Patients

Ampicillin and Sulbactam for Injection is generally well tolerated. The following adverse reactions have been reported.

Local Adverse Reactions

  •  Pain at IM injection site – 16%
  •  Pain at IV injection site – 3%
  •  Thrombophlebitis – 3%

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 Ampicillin and Sulbactam demonstrate a similar adverse events profile to those observed in adult patients. Additionally, atypical lymphocytosis has been observed in one pediatric patient receiving Ampicillin and Sulbactam.

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 reported with ampicillin-class antibiotics and can also occur with Ampicillin and Sulbactam for Injection.

Gastrointestinal

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

Hypersensitivity Reactions

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

Hematologic

In addition to the adverse laboratory changes listed above for Ampicillin and Sulbactam, agranulocytosis has been reported during therapy with penicillins. 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 Ampicillin and Sulbactam, as with other beta-lactam antibiotics.



REPORTS OF SUSPECTED AMPICILLIN AND SULBACTAM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Ampicillin and Sulbactam side effects / adverse reactions in 91 year old male

Reported by a pharmacist from United States on 2011-10-17

Patient: 91 year old male

Reactions: Rash

Adverse event resulted in: hospitalization

Suspect drug(s):
Ampicillin and Sulbactam
    Dosage: 3 gm bid iv
    Indication: Balanoposthitis
    Start date: 2011-09-21
    End date: 2011-09-23

Ampicillin and Sulbactam
    Dosage: 3 gm bid iv
    Indication: Cellulitis
    Start date: 2011-09-21
    End date: 2011-09-23



Possible Ampicillin and Sulbactam side effects / adverse reactions in 56 year old female

Reported by a pharmacist from United States on 2011-10-26

Patient: 56 year old female weighing 116.5 kg (256.3 pounds)

Reactions: Pruritus, Glossodynia, Lymphadenopathy, Vomiting, Nausea, Urticaria, Pain, Parotitis, Rash Erythematous, Erythema Multiforme, Papule

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ampicillin and Sulbactam
    Dosage: 3 gm other iv
    Indication: Soft Tissue Infection
    Start date: 2011-05-23
    End date: 2011-05-23

Ampicillin and Sulbactam
    Dosage: 3 gm other iv
    Indication: Urinary Tract Infection
    Start date: 2011-05-23
    End date: 2011-05-23

Ampicillin and Sulbactam
    Dosage: 3 gm other iv
    Indication: Skin Infection
    Start date: 2011-05-23
    End date: 2011-05-23



Possible Ampicillin and Sulbactam side effects / adverse reactions in 56 year old female

Reported by a pharmacist from United States on 2011-10-28

Patient: 56 year old female weighing 116.5 kg (256.3 pounds)

Reactions: Lymphadenopathy, Pruritus, Urticaria, Pyrexia, Local Swelling, Parotitis, Rash Morbilliform, Erythema Multiforme

Adverse event resulted in: life threatening event, hospitalization

Suspect drug(s):
Ampicillin and Sulbactam
    Dosage: 3 gm, other, iv
    Indication: Urinary Tract Infection
    Start date: 2011-05-23
    End date: 2011-05-23

Lamotrigine
    Dosage: 100 mg, every day, po
    Administration route: Oral
    Indication: Vascular Operation
    Start date: 2011-03-31
    End date: 2011-06-02

Lamotrigine
    Dosage: 100 mg, every day, po
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2011-03-31
    End date: 2011-06-02



See index of all Ampicillin and Sulbactam side effect reports >>

Drug label data at the top of this Page last updated: 2007-03-31

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