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Ampicillin Side Effects

In Summary

Commonly reported side effects of ampicillin include: eosinophilia and skin rash. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ampicillin: oral capsules, oral for suspension, parenteral powder for injection or infusion

Side effects include:

GI effects (diarrhea, nausea), rash.

For Healthcare Professionals

Applies to ampicillin: compounding powder, injectable powder for injection, oral capsule, oral powder for reconstitution

Dermatologic

Very common (10% or more): Rash, pruritus, exanthema, itching

Common (1% to 10%): Morbilliform rash

Uncommon (0.1% to 1%): Angioneurotic edema, allergic vasculitis, exfoliative dermatitis, exudative erythema multiforme, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis

Frequency not reported: Erythematous maculopapular rash (including mildly pruritic), macular rash, purpura, maculopapular rash, skin reactions (e.g., erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), other skin rashes, erythematous eruptions, acute generalized exanthematous pustulosis[Ref]

Gastrointestinal

Glossitis, stomatitis, black hairy tongue, nausea, vomiting, enterocolitis, pseudomembranous colitis, and diarrhea were typically associated with oral formulations.

Acute pancreatitis has been reported and confirmed by rechallenge with this drug in a patient in whom there was no other obvious cause of pancreatitis.[Ref]

Very common (10% or more): Diarrhea, nausea, vomiting, flatulence/meteorism, soft stools, abdominal pain

Uncommon (0.1% to 1%): Glossitis, stomatitis, enterocolitis, pseudomembranous colitis

Frequency not reported: Oral candidiasis/moniliasis, black hairy tongue, Clostridium difficile-associated diarrhea, hemorrhagic colitis, sore mouth/tongue, pancreatitis, gastritis, generalized abdominal cramps[Ref]

Local

Common (1% to 10%): Localized phlebitis

Frequency not reported: Phlebitis at IV administration site, pain at IM administration site[Ref]

Other

Common (1% to 10%): Swelling and pain, exanthema and enanthem in the oral region

Uncommon (0.1% to 1%): Infection with fungi/resistant bacteria (especially during prolonged and/or repeated use), drug fever

Frequency not reported: Fever (including high fever)[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Serious allergic reactions (e.g., serum sickness, allergic nephritis)

Rare (0.01% to 0.1%): Life-threatening anaphylactic shock

Frequency not reported: Anaphylaxis, serum sickness-like reactions, hypersensitivity reactions (including urticarial rash, erythema multiforme, exfoliative dermatitis, edema, hypotension, fever, eosinophilia, dyspnea, interstitial nephritis, Henoch-Schonlein purpura, focal glomerulonephritis, Stevens-Johnson syndrome, bullous pemphigoid, hypersensitivity myocarditis, toxic epidermal necrolysis, fixed drug eruptions)[Ref]

Hematologic

Uncommon (0.1% to 1%): Thrombocytopenia, thrombocytopenic purpura, leukopenia, anemia, eosinophilia, agranulocytosis, hemolytic anemia

Very rare (less than 0.01%): Granulocytopenia, pancytopenia, prolonged bleeding time, prolonged prothrombin time

Frequency not reported: Prolonged activated partial thromboplastin time, platelet aggregation abnormalities, neutropenia, Henoch Schonlein purpura, red cell aplasia[Ref]

Anemia, thrombocytopenia, hemolytic anemia, thrombocytopenic purpura, eosinophilia, leukopenia, and agranulocytosis have been reported during treatment with penicillins. In general, these reactions were reversible after stopping therapy and were believed to be sensitivity reactions.

Neutropenia was described in a case report of 3 pediatric patients who received high doses (150 to 400 mg/kg) of this drug IV. In all 3 cases, white blood cell and neutrophil counts returned to normal after discontinuation of therapy.[Ref]

Nervous system

Seizures have been reported with renal dysfunction or at very high IV doses.

Seizures have been reported in patients with high serum drug levels, although these patients were otherwise very ill. High cerebral spinal fluid (CSF) levels of some penicillins were known to be potentially neurotoxic, and the CSF level of this drug increased significantly in meningitis.

Generalized seizures have been described in 2 patients during use of this drug, although in both cases, there were underlying disease factors that may have predisposed the patients to seizure activity.

Encephalopathy has occurred when blood drug level reached 800 mg/L.

Toxic symptoms (e.g., drowsiness, hyperreflexia, myoclonic twitches, convulsions, coma) have occurred at lower drug levels in patients with meningitis; the blood-brain barrier became more permeable in meningitis.[Ref]

Rare (0.01% to 0.1%): Headache, dizziness, myoclonus, seizures

Frequency not reported: Encephalopathy, drowsiness, hyperreflexia, myoclonic twitches, convulsions, coma[Ref]

Renal

Uncommon (0.1% to 1%): Acute interstitial nephritis

Very rare (less than 0.01%): Acute renal failure with excretion of urine crystals

Frequency not reported: Interstitial nephritis, nephropathy, glomerulonephritis[Ref]

Hepatic

Uncommon (0.1% to 1%): Transaminase elevation

Frequency not reported: Hepatitis, cholestatic jaundice, elevated AST, moderately increased transaminases (transient), elevated ALT, cholestasis[Ref]

Mild, temporary elevation in AST reported in patients who received larger (2 to 4 times) and more frequent IM injections than usual. Evidence indicated AST was released at IM injection sites for this drug and increased AST did not necessarily indicate liver involvement.[Ref]

Genitourinary

Crystalluria has been reported with high-dose IV administration.[Ref]

Uncommon (0.1% to 1%): Crystalluria

Frequency not reported: Vaginal candidiasis/moniliasis[Ref]

Respiratory

Uncommon (0.1% to 1%): Laryngeal edema

Frequency not reported: Laryngeal stridor[Ref]

Musculoskeletal

Frequency not reported: Arthralgia

Metabolic

Frequency not reported: Anorexia

References

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

2. "Product Information. Polycillin (ampicillin)." Apothecon Inc, Plainsboro, NJ.

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

4. Sidoroff A, Dunant A, Viboud C, et al. "Risk factors for acute generalized exanthematous pustulosis (AGEP)-results of a multinational case-control study (EuroSCAR)." Br J Dermatol 157 (2007): 989-96

5. 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

6. Cobbs CG, Livingston W "Shigella sonnei gastroenteritis after oral ampicillin therapy for an unrelated disorder." South Med J 73 (1980): 1545-6

7. Hanline MH "Acute pancreatitis caused by ampicillin." South Med J 80 (1987): 1069

8. 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

9. Midtvedt T, Carlstedt-Duke B, Hoverstad T, et al "Influence of peroral antibiotics upon the biotransformatory activity of the intestinal microflora in healthy subjects." Eur J Clin Invest 16 (1986): 11-7

10. Guay DR, Craft JC "Comparative safety and efficacy of clarithromycin and ampicillin in the treatment of out-patients with acute bacterial exacerbation of chronic bronchitis." J Intern Med 231 (1992): 295-301

11. Brause BD, Romankiewicz JA, Gotz V, Franklin JE Jr, Roberts RB "Comparative study of diarrhea associated with clindamycin and ampicillin therapy." Am J Gastroenterol 73 (1980): 244-8

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

13. Koklu S, Yuksel O, Filik L, Uskudar O, Altundag K, Altiparmak E "Recurrent cholestasis due to ampicillin." Ann Pharmacother 37 (2003): 395-7

14. 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

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

16. 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

17. Castro SM, Schwartz RH, Nazarian LF "Ampicillin and amoxicillin delayed hypersensitivity: Side-chain-specific allergic reactions in a child." Pediatr Asthma Allerg Immun 10 (1996): 197-203

18. Chikwava KR, Savell VH Jr, Boyd TK "Fatal cephalosporin-induced acute hypersensitivity myocarditis." Pediatr Cardiol 27 (2006): 777-80

19. Adcock BB, Rodman DP "Ampicillin-specific rashes." Arch Fam Med 5 (1996): 301-4

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

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

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

23. Garty BZ, Offer I, Livni E, Danon YL "Erythema multiforme and hypersensitivity myocarditis caused by ampicillin." Ann Pharmacother 28 (1994): 730-1

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

25. Marra CA, Shalansky KF "Ampicillin-induced macropapular versus urticarial rash." Ann Pharmacother 30 (1996): 401-2

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

27. 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

28. 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

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

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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