Principen Side Effects
Generic name: ampicillin
Medically reviewed by Drugs.com. Last updated on Feb 2, 2022.
Note: This document contains side effect information about ampicillin. Some dosage forms listed on this page may not apply to the brand name Principen.
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.
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]
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]
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]
Common (1% to 10%): Localized phlebitis
Frequency not reported: Phlebitis at IV administration site, pain at IM administration site[Ref]
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]
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]
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]
Rare (0.01% to 0.1%): Headache, dizziness, myoclonus, seizures
Frequency not reported: Encephalopathy, drowsiness, hyperreflexia, myoclonic twitches, convulsions, coma[Ref]
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]
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]
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]
Uncommon (0.1% to 1%): Transaminase elevation
Frequency not reported: Hepatitis, cholestatic jaundice, elevated AST, moderately increased transaminases (transient), elevated ALT, cholestasis[Ref]
Crystalluria has been reported with high-dose IV administration.[Ref]
Uncommon (0.1% to 1%): Crystalluria
Frequency not reported: Vaginal candidiasis/moniliasis[Ref]
Uncommon (0.1% to 1%): Laryngeal edema
Frequency not reported: Laryngeal stridor[Ref]
Frequency not reported: Arthralgia
Frequency not reported: Anorexia
More about Principen (ampicillin)
- Check interactions
- Compare alternatives
- Drug images
- Dosage information
- During pregnancy
- Drug class: aminopenicillins
Related treatment guides
1. Poe RH, Condemi JJ, Weinstein SS, Schuster RJ "Adult respiratory distress syndrome related to ampicillin sensitivity." Chest 3 (1980): 449-51
2. Chan HL "Fixed drug eruption to bacampicillin (ampicillin)." Arch Dermatol 120 (1984): 542
3. 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
4. "Product Information. Polycillin-PRB (ampicillin-probenecid)." Apothecon Inc
5. 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
6. Cobbs CG, Livingston W "Shigella sonnei gastroenteritis after oral ampicillin therapy for an unrelated disorder." South Med J 73 (1980): 1545-6
7. 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
8. Craig WA, Gerber AU "Worldwide experience with bacampicillin administered twice a day." Rev Infect Dis 3 (1981): 171-7
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. Hanline MH "Acute pancreatitis caused by ampicillin." South Med J 80 (1987): 1069
11. 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
12. 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
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. 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
15. Tagami H, Tatsuta K, Iwatski K, Yamada M "Delayed hypersensitivity in ampicillin-induced toxic epidermal necrolysis." Arch Dermatol 119 (1983): 910-3
16. Guinta JL, Fiumara N "Ampicillin allergy presenting as secondary syphilis." Oral Surg Oral Med Oral Patho 2 (1984): 152-4
17. Konstantinidis AB, Markopoulos A, Trigonides G "Ampicillin induced erythema multiforme." J Oral Med 40 (1985): 168-70
18. Hodak E, Ben-Shetrit A, Ingber A, Sandbank M "Bullous pemphigoid: an adverse effect of ampicillin." Clin Exp Dermatol 15 (1990): 50-2
19. Heim K, Alge A, Marth C "Anaphylactic reaction to ampicillin and severe complication in the fetus." Lancet 337 (1991): 859-60
20. 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
21. Garty BZ, Offer I, Livni E, Danon YL "Erythema multiforme and hypersensitivity myocarditis caused by ampicillin." Ann Pharmacother 28 (1994): 730-1
22. Marra CA, Shalansky KF "Ampicillin-induced macropapular versus urticarial rash." Ann Pharmacother 30 (1996): 401-2
23. Adcock BB, Rodman DP "Ampicillin-specific rashes." Arch Fam Med 5 (1996): 301-4
24. 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
25. Chikwava KR, Savell VH Jr, Boyd TK "Fatal cephalosporin-induced acute hypersensitivity myocarditis." Pediatr Cardiol 27 (2006): 777-80
26. 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
27. Hughes GS "Ampicillin and hematologic effects." Ann Intern Med 99 (1983): 573
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
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.