Unasyn Side Effects
Generic name: ampicillin / sulbactam
Medically reviewed by Drugs.com. Last updated on Mar 1, 2024.
Note: This document provides detailed information about Unasyn Side Effects associated with ampicillin / sulbactam. Some dosage forms listed on this page may not apply specifically to the brand name Unasyn.
Applies to ampicillin / sulbactam: injection powder for solution.
Precautions
Your doctor will check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
This medicine may cause serious allergic reactions, including anaphylaxis or certain skin conditions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
Ampicillin and sulbactam combination may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. Diarrhea medicines may make the diarrhea worse or make it last longer. If you have any questions about this or if mild diarrhea continues or gets worse, check with your doctor.
This medicine may decrease the effects of some oral contraceptives (birth control pills). To avoid an unwanted pregnancy, it is a good idea to use additional contraceptive measures with your pills (eg, condoms, a diaphragm, or a contraceptive foam or jelly) while using this medicine.
Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Common side effects of Unasyn
Some side effects of ampicillin / sulbactam may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- 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 side effects
- 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
Serious side effects of Unasyn
Along with its needed effects, ampicillin / sulbactam may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur while taking ampicillin / sulbactam:
Less common side effects
- changes in skin color
- diarrhea
- pain, tenderness, or swelling of the foot or leg
Rare side effects
- bloody nose
- burning while urinating
- chest pain, discomfort, or pressure
- chills
- decrease in the 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
For healthcare professionals
Applies to ampicillin / sulbactam: injectable powder for injection.
General adverse events
This drug was generally well-tolerated.[Ref]
Local
- Very common (10% or more): Pain at IM injection site (16%)
- Common (1% to 10%): Pain at IV injection site, thrombophlebitis, phlebitis
- Postmarketing reports: Injections site reaction[Ref]
Gastrointestinal
- Common (1% to 10%): Diarrhea
- Uncommon (0.1% to 1%): Nausea, vomiting, flatulence, abdominal distension, glossitis
- Frequency not reported: Pancreatitis, enterocolitis, pseudomembranous colitis
- Postmarketing reports: Gastritis, stomatitis, black "hairy" tongue, Clostridium difficile associated diarrhea[Ref]
Hypersensitivity
- Frequency not reported: Hypersensitivity reactions to ampicillin (including urticarial rash, edema, hypotension, fever, eosinophilia, dyspnea, delayed hypersensitivity maculopapular rash, anaphylaxis, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, Stevens-Johnson syndrome)
- Postmarketing reports: Serious and fatal hypersensitivity (anaphylactic) reactions[Ref]
Dermatologic
- Common (1% to 10%): Rash
- Uncommon (0.1% to 1%): Itching, facial swelling, erythema
- Frequency not reported: Ampicillin-associated bullous pemphigoid, linear IgA dermatosis, pseudoporphyria
- Postmarketing reports: Erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, urticaria, exfoliative dermatitis[Ref]
Hematologic
- Frequency not reported: Decreased hemoglobin, decreased hematocrit, decreased red blood cells, decreased white blood cells, decreased neutrophils, decreased lymphocytes, decreased platelets, increased lymphocytes, increased monocytes, increased basophils, increased eosinophils, increased platelets, thrombocytopenia, leukopenia, red cell aplasia, anemia, atypical lymphocytosis
- Postmarketing reports: Hemolytic anemia, thrombocytopenic purpura, agranulocytosis, positive direct Coombs test[Ref]
Hemolytic anemia, thrombocytopenic purpura, and agranulocytosis were generally reversible when therapy was discontinued; may be hypersensitivity events.[Ref]
Nervous system
- Uncommon (0.1% to 1%): Headache
- Frequency not reported: Seizures, neurotoxic potential, worsening myasthenia gravis symptoms
- Postmarketing reports: Convulsion[Ref]
Seizures have been reported in very ill patients with high serum levels of ampicillin. High cerebral spinal fluid (CSF) levels of some penicillins are potentially neurotoxic; the CSF levels of ampicillin rise significantly in meningitis.[Ref]
Hepatic
- Frequency not reported: Increased AST, increased ALT, hepatitis, prolonged cholestasis
- Postmarketing reports: Cholestatic hepatitis, cholestasis, hyperbilirubinemia, jaundice, abnormal hepatic function[Ref]
Metabolic
- Frequency not reported: Increased alkaline phosphatase, increased lactate dehydrogenase, decreased serum albumin, decreased total protein[Ref]
Genitourinary
- Uncommon (0.1% to 1%): Urine retention, dysuria
- Frequency not reported: Urinary red blood cells, urinary hyaline casts[Ref]
Renal
- Frequency not reported: Increased BUN, increased creatinine
- Postmarketing reports: Tubulointerstitial nephritis[Ref]
Other
- Uncommon (0.1% to 1%): Candidiasis, fatigue, malaise, chest pain, edema, chills, substernal pain, mucosal bleeding[Ref]
Respiratory
- Uncommon (0.1% to 1%): Throat tightness, epistaxis
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References
1. "Multum Information Services, Inc. Expert Review Panel"
2. (2002) "Product Information. Unasyn (ampicillin-sulbactam)." Roerig Division
3. Ramakrishnan K, Scheid DC (2005) "Diagnosis and management of acute pyelonephritis in adults." Am Fam Physician, 71, p. 933-42
4. Ott SR, Allewelt M, Lorenz J, Reimnitz P, Lode H (2008) "Moxifloxacin vs ampicillin / sulbactam in aspiration pneumonia and primary lung abscess." Infection, 36, p. 23-30
5. Poe RH, Condemi JJ, Weinstein SS, Schuster RJ (1980) "Adult respiratory distress syndrome related to ampicillin sensitivity." Chest, 3, p. 449-51
6. Craig WA, Gerber AU (1981) "Worldwide experience with bacampicillin administered twice a day." Rev Infect Dis, 3, p. 171-7
7. Beeching NJ, Gruer LD, Findlay CD, Geddes AM (1982) "A case of Henoch-Schonlein purpura syndrome following oral ampicillin." J Antimicrob Chemother, 10, p. 479-82
8. Tagami H, Tatsuta K, Iwatski K, Yamada M (1983) "Delayed hypersensitivity in ampicillin-induced toxic epidermal necrolysis." Arch Dermatol, 119, p. 910-3
9. Chan HL (1984) "Fixed drug eruption to bacampicillin (ampicillin)." Arch Dermatol, 120, p. 542
10. Guinta JL, Fiumara N (1984) "Ampicillin allergy presenting as secondary syphilis." Oral Surg Oral Med Oral Patho, 2, p. 152-4
11. Konstantinidis AB, Markopoulos A, Trigonides G (1985) "Ampicillin induced erythema multiforme." J Oral Med, 40, p. 168-70
12. Mehta D, Warwick GL, Goldberg MJ (1986) "QT prolongation after ampicillin anaphylaxis." Br Heart J, 55, p. 308-10
13. Dolovich J, Ruhno J, Sauder DN, Ahlstedt S, Hargreave FE (1988) "Isolated late cutaneous skin test response to ampicillin: a distinct entity." J Allergy Clin Immunol, 82, p. 676-9
14. Hodak E, Ben-Shetrit A, Ingber A, Sandbank M (1990) "Bullous pemphigoid: an adverse effect of ampicillin." Clin Exp Dermatol, 15, p. 50-2
15. Heim K, Alge A, Marth C (1991) "Anaphylactic reaction to ampicillin and severe complication in the fetus." Lancet, 337, p. 859-60
16. Johnson JR, Lyons MF, Pearce W, et al. (1991) "Therapy for women hospitalized with acute pyelonephritis: a randomized trial of ampicillin versus trimethoprim-sulfamethoxasole for 14 days." J Infect Dis, 163, p. 325-30
17. Cavanzo FJ, Garcia CF, Botero RC (1990) "Chronic cholestasis, paucity of bile ducts, red cell aplasia, and the Stevens-Johnson syndrome." Gastroenterology, 99, p. 854-6
18. Blomqvist M, Hedtrom SA (1987) "The clinical efficacy and safety of bacampicillin twice daily in comparative studies." J Int Med Res, 15, p. 32-43
19. Shimanovich I, Rose C, Sitaru C, Brocker EB, Zillikens D (2004) "Localized linear IgA disease induced by ampicillin / sulbactam." J Am Acad Dermatol, 51(1 Pt 1), p. 95-8
20. Berliner S, Sidi Y, Shaklai M, Pinkhas J (1982) "Appearance of thrombocytopenia and benign monoclonal gammopathy following intake of drugs." Acta Haematol, 67, p. 71-2
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Further information
Unasyn side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.