Unasyn Side Effects

Generic Name: ampicillin / sulbactam

Note: This page contains side effects data for the generic drug ampicillin / sulbactam. It is possible that some of the dosage forms included below may not apply to the brand name Unasyn.

It is possible that some side effects of Unasyn may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to ampicillin / sulbactam: injection powder for solution

As well as its needed effects, ampicillin / sulbactam may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking ampicillin / sulbactam, check with your doctor or nurse immediately:

Less common
  • Changes in skin color
  • diarrhea
  • pain, tenderness, or swelling of the foot or leg
Rare
  • Bloody nose
  • burning while urinating
  • chest pain, discomfort, or pressure
  • chills
  • decrease in frequency of urination
  • decrease in urine volume
  • difficulty in passing urine (dribbling)
  • flushing or redness of the skin
  • painful urination
  • swelling
  • swelling or puffiness of the face
  • tightness in the throat
  • unusually warm skin
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • black, hairy tongue
  • blistering, peeling, or loosening of the skin
  • bloating
  • cough or hoarseness
  • cracks in the skin
  • diarrhea, watery and severe, which may also be bloody
  • fever
  • fever with or without chills
  • general feeling of tiredness or weakness
  • increased thirst
  • itching
  • joint or muscle pain
  • loss of heat from the body
  • lower back or side pain
  • nausea or vomiting
  • pain
  • red, irritated eyes
  • red, swollen skin
  • scaly skin
  • severe stomach pain
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling or inflammation of the mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • unusual weight loss
  • vomiting

Some ampicillin / sulbactam side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Rare
  • Excess air or gas in the stomach or intestines
  • full or bloated feeling
  • general feeling of discomfort or illness
  • headache
  • passing gas
  • pressure in the stomach
  • redness, swelling, or soreness of the tongue
  • swelling of the abdominal or stomach area
  • white patches in the mouth or throat or on the tongue
  • white patches with diaper rash
Incidence not known
  • Burning feeling in the chest or stomach
  • indigestion
  • stomach upset

For Healthcare Professionals

Applies to ampicillin / sulbactam: injectable powder for injection

General

Ampicillin-sulbactam is generally well-tolerated.[Ref]

Local

Local side effects have included pain at the intramuscular injection site (16%), pain at the intravenous injection site (3%), and thrombophlebitis (3%).[Ref]

Gastrointestinal

Gastrointestinal side effects have included diarrhea (3%), nausea (<1%), vomiting (<1%), flatulence (<1%), abdominal distension (<1%), and glossitis (<1%). Rare cases of pancreatitis have been reported. Ampicillin-class antibiotics have been associated with gastritis, stomatitis, black hairy tongue, enterocolitis, and pseudomembranous colitis.[Ref]

Hypersensitivity

Hypersensitivity reactions to ampicillin have included urticarial rash, edema, hypotension, fever, eosinophilia, dyspnea, a delayed hypersensitivity maculopapular rash, anaphylaxis, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, and Stevens-Johnson syndrome.[Ref]

Dermatologic

Dermatologic side effects have included rash (<2%), itching (<1%), erythema multiforme, and exfoliative dermatitis. Rare cases of ampicillin-associated bullous pemphigoid, linear IgA dermatosis, and pseudoporphyria have been reported.[Ref]

Hematologic

Hematologic side effects have included decreases in hemoglobin, hematocrit, red blood cells, neutrophils, lymphocytes, and platelets, and increases in lymphocytes, monocytes, basophils, eosinophils, and platelets. Thrombocytopenia, leukopenia, red cell aplasia, anemia, and positive direct Coombs test have rarely been reported. Atypical lymphocytosis has been reported in a pediatric patient. Penicillins have been associated with agranulocytosis.[Ref]

Nervous system

Nervous system side effects have included seizures in very ill patients with high serum concentrations of ampicillin. High cerebral spinal fluid (CSF) levels of some penicillins are known to be potentially neurotoxic, and the CSF concentrations of ampicillin rise significantly in meningitis. Ampicillin may worsen myasthenia gravis symptoms.[Ref]

Hepatic

Hepatic side effects have included increases in AST (SGOT), ALT (SGPT), alkaline phosphatase, and LDH. Rare cases of hepatitis and prolonged cholestasis have been reported.[Ref]

Metabolic

Metabolic side effects have included decreases in serum albumin and total protein.[Ref]

Genitourinary

Genitourinary side effects have included urine retention, dysuria, urinary red blood cells, and urinary hyaline casts. Superinfections may occur (i.e., Candida, Pseudomonas).[Ref]

Renal

Renal side effects have included increases in BUN and creatinine.[Ref]

Other

Other side effects have included facial swelling, erythema, chills, throat tightness, substernal pain, epistaxis, and mucosal bleeding.[Ref]

References

1. "Multum Information Services, Inc. Expert Review Panel"

2. "Product Information. Unasyn (ampicillin-sulbactam)." Roerig Division, New York, NY.

3. Ramakrishnan K, Scheid DC "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician 71 (2005): 933-42

4. Ott SR, Allewelt M, Lorenz J, Reimnitz P, Lode H "Moxifloxacin vs ampicillin / sulbactam in aspiration pneumonia and primary lung abscess." Infection 36 (2008): 23-30

5. Guinta JL, Fiumara N "Ampicillin allergy presenting as secondary syphilis." Oral Surg Oral Med Oral Patho 2 (1984): 152-4

6. Mehta D, Warwick GL, Goldberg MJ "QT prolongation after ampicillin anaphylaxis." Br Heart J 55 (1986): 308-10

7. Cavanzo FJ, Garcia CF, Botero RC "Chronic cholestasis, paucity of bile ducts, red cell aplasia, and the Stevens-Johnson syndrome." Gastroenterology 99 (1990): 854-6

8. Beeching NJ, Gruer LD, Findlay CD, Geddes AM "A case of Henoch-Schonlein purpura syndrome following oral ampicillin." J Antimicrob Chemother 10 (1982): 479-82

9. Craig WA, Gerber AU "Worldwide experience with bacampicillin administered twice a day." Rev Infect Dis 3 (1981): 171-7

10. Hodak E, Ben-Shetrit A, Ingber A, Sandbank M "Bullous pemphigoid: an adverse effect of ampicillin." Clin Exp Dermatol 15 (1990): 50-2

11. Dolovich J, Ruhno J, Sauder DN, Ahlstedt S, Hargreave FE "Isolated late cutaneous skin test response to ampicillin: a distinct entity." J Allergy Clin Immunol 82 (1988): 676-9

12. Tagami H, Tatsuta K, Iwatski K, Yamada M "Delayed hypersensitivity in ampicillin-induced toxic epidermal necrolysis." Arch Dermatol 119 (1983): 910-3

13. Chan HL "Fixed drug eruption to bacampicillin (ampicillin)." Arch Dermatol 120 (1984): 542

14. Poe RH, Condemi JJ, Weinstein SS, Schuster RJ "Adult respiratory distress syndrome related to ampicillin sensitivity." Chest 3 (1980): 449-51

15. Johnson JR, Lyons MF, Pearce W, et al "Therapy for women hospitalized with acute pyelonephritis: a randomized trial of ampicillin versus trimethoprim-sulfamethoxasole for 14 days." J Infect Dis 163 (1991): 325-30

16. Heim K, Alge A, Marth C "Anaphylactic reaction to ampicillin and severe complication in the fetus." Lancet 337 (1991): 859-60

17. Konstantinidis AB, Markopoulos A, Trigonides G "Ampicillin induced erythema multiforme." J Oral Med 40 (1985): 168-70

18. Blomqvist M, Hedtrom SA "The clinical efficacy and safety of bacampicillin twice daily in comparative studies." J Int Med Res 15 (1987): 32-43

19. Shimanovich I, Rose C, Sitaru C, Brocker EB, Zillikens D "Localized linear IgA disease induced by ampicillin / sulbactam." J Am Acad Dermatol 51(1 Pt 1) (2004): 95-8

20. Berliner S, Sidi Y, Shaklai M, Pinkhas J "Appearance of thrombocytopenia and benign monoclonal gammopathy following intake of drugs." Acta Haematol 67 (1982): 71-2

21. Singh N, Yu VL, Mieles LA, Wagener MM "Beta-lactam antibiotic-induced leukopenia in severe hepatic dysfunction: risk factors and implications for dosing in patients with liver disease." Am J Med 94 (1993): 251-6

22. Hughes GS "Ampicillin and hematologic effects." Ann Intern Med 99 (1983): 573

23. Argov Z, Brenner T, Abramsky O "Ampicillin may aggravate clinical and experimental myasthenia gravis." Arch Neurol 43 (1986): 255-6

24. Hodgman T, Dasta JF, Armstrong DK, Visconti JA, Reilley TE "Ampicillin-associated seizures." South Med J 77 (1984): 1323-5

25. Koklu S, Koksal AS, Asil M, Kiyici H, Coban S, Arhan M "Probable sulbactam/ampicillin-associated prolonged cholestasis." Ann Pharmacother 38 (2004): 2055-8

26. Moesch C, Rince M, Raby C, Denis F, Leroux-Robert C "Crystalluria following aminopenicillin therapy." Clin Nephrol 23 (1985): 318-9

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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