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penicillin V Side Effects

Also known as: Pen-Vee K

Analysis of 2,398 adverse event reports submitted to the FDA from 2004 to 2025.

Total Reports

2,398

Death-Related

171

7.1% of reports

Hospitalizations

612

25.5% of reports

Top Indication

Product Used For Unknown Indication

Most Reported Adverse Reactions

DRUG HYPERSENSITIVITY
457
DYSPNOEA
211
ANXIETY
178
HYPERSENSITIVITY
149
ASTHMA
145
CONDITION AGGRAVATED
143
FATIGUE
135
RASH
130
THERAPEUTIC PRODUCT EFFECT INCOMPLETE
123
PAIN IN EXTREMITY
122
WHEEZING
119
HYPOTHYROIDISM
116
OBSTRUCTIVE AIRWAYS DISORDER
116
OFF LABEL USE
114
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION
110
PAIN
106
FULL BLOOD COUNT ABNORMAL
103
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES
103
NAUSEA
99
PULMONARY EMBOLISM
98

Who Reports Side Effects

Gender Distribution

Female 1,315 (61%)
Male 818 (38%)
Unknown 16

Age Distribution

0-17 141 (11%)
18-44 320 (25%)
45-64 391 (31%)
65-74 280 (22%)
75+ 140 (11%)

Reporting Trend by Year

2004 2025

Reactions in Death Reports

Top reactions reported in 171 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 85
DYSPNOEA 52
ANXIETY 48
PULMONARY EMBOLISM 48
CONDITION AGGRAVATED 46
PAIN IN EXTREMITY 44
ARTERIOSCLEROSIS 40
HAEMOPTYSIS 40
HYPOXIA 40
THROMBOSIS 40
ASTHMA 39
FULL BLOOD COUNT ABNORMAL 39
ANTINEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE 38
ARTERIOSCLEROSIS CORONARY ARTERY 38
CONJUNCTIVITIS ALLERGIC 38
DUST ALLERGY 38
EOSINOPHILIC GRANULOMATOSIS WITH POLYANGIITIS 38
HYPOTHYROIDISM 38
MITE ALLERGY 38
MYCOTIC ALLERGY 38

Reactions in Hospitalization Reports

Top reactions in 612 reports where hospitalization was an outcome.

Reaction Reports
DYSPNOEA 118
PULMONARY EMBOLISM 95
ANXIETY 94
ASTHMA 84
CONDITION AGGRAVATED 84
PAIN IN EXTREMITY 80
OBSTRUCTIVE AIRWAYS DISORDER 75
WHEEZING 75
THERAPEUTIC PRODUCT EFFECT INCOMPLETE 74
PRODUCTIVE COUGH 72
LUNG DISORDER 71
THROMBOSIS 71
HYPOXIA 70
PULMONARY FIBROSIS 70
HAEMOPTYSIS 69
NEURITIS 69
NEUROLOGICAL SYMPTOM 69
PULMONARY ALVEOLAR HAEMORRHAGE 69
SLEEP DISORDER DUE TO A GENERAL MEDICAL CONDITION 69
HYPOTHYROIDISM 68

Nearby — Related Medications

Compare penicillin V vs amikacin →

What the FAERS Data Reveals About penicillin V Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 2,398 voluntary reports linked to penicillin V and its brand equivalents (Pen-Vee K), spanning 2004 through 2025. Of those, 171 (7.1%) listed death as an outcome and 612 (25.5%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 61% were female and 38% male; age distribution skews toward 45-64, with 391 reports in that bracket. The single most reported reaction is drug hypersensitivity with 457 submissions, followed by dyspnoea and anxiety.

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice — speak with a licensed clinician about any side-effect concerns.