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What the label lists and what reports show

Penicillin v side effects

Penicillin v's FDA label: “The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue.” FAERS holds 2,540 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is drug hypersensitivity (467 reports).

  • Generic listed

Check it at the source: the penicillin v FDA label on DailyMed (effective June 25, 2024, Hikma Pharmaceuticals USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue.

From the label: adverse reactions, continued

Although the incidence of reactions to oral penicillins has been reported with much less frequency than following parenteral therapy, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been reported with oral penicillin. The most common reactions to oral penicillin are nausea, vomiting, epigastric distress, diarrhea, and black hairy tongue. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sickness like reactions, laryngeal edema, and anaphylaxis. Fever and eosinophilia may frequently be the only reaction observed. Hemolytic anemia, leukopenia, thrombocytopenia, neuropathy, and nephropathy are infrequent reactions and usually associated with high doses of parenteral penicillin. To report SUSPECTED ADVERSE REACTIONS, contact Hikma Pharmaceuticals USA Inc. at 1-877-233-2001, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Hikma Pharmaceuticals USA Inc., effective June 25, 2024 (SPL set dc33f7a4-348b-4b4c-a5f2-c4f908fda4aa), via openFDA; the full label on DailyMed

What do FAERS reports show?

2,540 reports list penicillin v among the medicines taken, each a report of something that happened, not proof the medicine caused it; 189 are coded as a death and 656 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Drug Hypersensitivity467
  • Dyspnoea220
  • Anxiety180
  • Hypersensitivity (named in the label)155
  • Condition Aggravated (a use or a product term, not a reaction)148
  • Asthma146
  • Fatigue142
  • Rash136
  • Off Label Use (a use or a product term, not a reaction)124
  • Pain In Extremity123
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)123
  • Wheezing120
  • Hypothyroidism116
  • Obstructive Airways Disorder116
  • Sleep Disorder Due To A General Medical Condition110
  • Pain107
  • Full Blood Count Abnormal104
  • Drug Ineffective (a use or a product term, not a reaction)103
  • Loss Of Personal Independence In Daily Activities103
  • Nausea (named in the label)102
  • Pulmonary Embolism99
  • Lung Disorder98
  • Death (an outcome recorded in the report)97
  • Diarrhoea (named in the label)96
  • Pneumonia (a use or a product term, not a reaction)93

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Penicillin v: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions