Drug · FAERS side-effect profile with label screen
Penicillin V side effects: what 2,540 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Penicillin V Potassium (Penicillin V Potassium)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
2,540 reports · 56% serious · 189 with death outcome · 61% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of penicillin V potassium and other antibacterial drugs, penicillin V potassium should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA label, Indications and Usage
What it is
DESCRIPTION Penicillin V is the phenoxymethyl analog of penicillin G. Penicillin V potassium is the potassium salt of penicillin V. Penicillin V potassium tablets, for oral administration, contain 250 mg (400,000 units) or 500 mg (800,000 units).
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 3Lab value / disease marker 1Not in label — unassessed 32
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 53 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Obstructive airways disorder | 116 | 86.7 72.5–103.7ROR 90.8 · χ² 9,642 / p <1e-300 | 84.6 EB05 72.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 · ♀ 26% (drug 61%) | no trial data cached |
| Full blood count abnormal | 104 | 82.2 68.1–99.4ROR 85.7 · χ² 8,186 / p <1e-300 | 80.3 EB05 68.1 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 111.1 · ♀ 23% (drug 61%) | no trial data cached |
| Vasculitis | 86 | 61.3 49.8–75.6ROR 63.5 · χ² 5,010 / p <1e-300 | 60.1 EB05 50.2 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 67.3 · ♀ 0% (drug 61%) | no trial data cached |
| Arteriosclerosis | 68 | 60.0 47.4–75.9ROR 61.6 · χ² 3,858 / p <1e-300 | 58.6 EB05 47.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 63.1 · ♀ 0% (drug 61%) | no trial data cached |
| Sleep disorder due to a general medical condition | 110 | 56.5 47.1–67.9ROR 59.0 · χ² 5,909 / p <1e-300 | 55.6 EB05 47.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 114.2 · ♀ 26% (drug 61%) | no trial data cached |
| Nodule | 68 | 43.2 34.2–54.7ROR 44.4 · χ² 2,750 / p <1e-300 | 42.5 EB05 34.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 68.4 · ♀ 0% (drug 61%) | no trial data cached |
| Pulmonary fibrosis | 90 | 39.1 31.9–47.9ROR 40.5 · χ² 3,286 / p <1e-300 | 38.6 EB05 32.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 40.4 · ♀ 0% (drug 61%) | no trial data cached |
| Hypothyroidism | 116 | 30.2 25.3–36.1ROR 31.6 · χ² 3,236 / p <1e-300 | 29.9 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 27% (drug 61%) | no trial data cached |
| Haemoptysis | 90 | 26.7 21.8–32.7ROR 27.6 · χ² 2,193 / p <1e-300 | 26.4 EB05 22.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 30.7 · ♀ 0% (drug 61%) | no trial data cached |
| Drug hypersensitivity | 467 | 19.9 18.3–21.6ROR 24.2 · χ² 8,420 / p <1e-300 | 19.8 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Loss of personal independence in daily activities | 103 | 17.9 14.8–21.7ROR 18.6 · χ² 1,628 / p <1e-300 | 17.8 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · ♀ 29% (drug 61%) | no trial data cached |
| Hypoxia (low oxygen) | 73 | 17.2 13.7–21.6ROR 17.7 · χ² 1,099 / p 3e-241 | 17.1 EB05 14.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · ♀ 4% (drug 61%) | no trial data cached |
| Wheezing | 120 | 16.8 14.1–20.0ROR 17.6 · χ² 1,766 / p <1e-300 | 16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 27% (drug 61%) | no trial data cached |
| Lung disorder | 98 | 16.6 13.6–20.1ROR 17.2 · χ² 1,417 / p <1e-300 | 16.5 EB05 13.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 7% (drug 61%) | no trial data cached |
| Productive cough (cough with phlegm) | 83 | 14.5 11.7–17.9ROR 15.0 · χ² 1,030 / p 3e-226 | 14.4 EB05 11.9 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 · ♀ 11% (drug 61%) | no trial data cached |
| Therapeutic product effect incomplete | 123 | 14.4 12.1–17.1ROR 15.1 · χ² 1,521 / p <1e-300 | 14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 26.8 · ♀ 34% (drug 61%) | no trial data cached |
| Tooth fracture | 17 | 12.7 7.9–20.5ROR 12.8 · χ² 172 / p 1e-39 | 11.8 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.7 | no trial data cached |
| Dental caries | 15 | 11.2 6.8–18.6ROR 11.3 · χ² 130 / p 3e-30 | 9.9 EB05 5.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 | no trial data cached |
| Asthma | 146 | 10.8 9.2–12.6ROR 11.4 · χ² 1,289 / p 2e-282 | 10.6 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 38% (drug 61%) | no trial data cached |
| Tooth infection | 16 | 10.0 6.1–16.3ROR 10.1 · χ² 121 / p 2e-28 | 8.7 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.9 | no trial data cached |
| Product use complaint | 18 | 9.6 6.1–15.2ROR 9.7 · χ² 130 / p 2e-30 | 8.4 EB05 5.4 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Economic problem | 16 | 8.6 5.3–14.0ROR 8.6 · χ² 100 / p 9e-24 | 7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 9.6 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 99 | 8.6 7.1–10.4ROR 8.9 · χ² 657 / p 4e-145 | 8.3 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 15% (drug 61%) | no trial data cached |
| Toothache | 18 | 8.2 5.2–13.0ROR 8.3 · χ² 107 / p 2e-25 | 7.1 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Thrombosis | 77 | 7.9 6.3–9.8ROR 8.1 · χ² 457 / p 9e-102 | 7.6 EB05 6.3 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 · ♀ 10% (drug 61%) | no trial data cached |
| Anhedonia | 23 | 7.2 4.8–10.8ROR 7.2 · χ² 116 / p 2e-27 | 6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 | no trial data cached |
| Tooth loss | 18 | 7.1 4.5–11.3ROR 7.2 · χ² 89 / p 2e-21 | 6.2 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Osteopenia | 13 | 7.0 4.1–12.1ROR 7.1 · χ² 61 / p 2e-15 | 5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Taste disorder | 17 | 7.0 4.4–11.3ROR 7.0 · χ² 82 / p 8e-20 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 | no trial data cached |
| Hypersensitivity (allergic reaction) | 155 | 6.9 5.9–8.0ROR 7.3 · χ² 784 / p 1e-172 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 76% consumer | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 41 | 6.2 4.6–8.4ROR 6.3 · χ² 173 / p 1e-39 | 5.8 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 82% (drug 61%) | no trial data cached |
| Tooth disorder | 16 | 5.9 3.6–9.6ROR 5.9 · χ² 61 / p 4e-15 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Bone disorder | 13 | 5.8 3.4–10.1ROR 5.9 · χ² 47 / p 3e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Clostridium difficile infection | 15 | 5.7 3.5–9.5ROR 5.7 · χ² 54 / p 1e-13 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 | no trial data cached |
| Intervertebral disc protrusion | 15 | 5.7 3.4–9.4ROR 5.7 · χ² 53 / p 2e-13 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Liver injury | 16 | 5.5 3.4–8.9ROR 5.5 · χ² 54 / p 1e-13 | 4.8 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Chronic kidney disease | 49 | 5.3 4.0–7.0ROR 5.4 · χ² 166 / p 2e-38 | 5.0 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Anxiety | 180 | 5.2 4.5–6.0ROR 5.5 · χ² 616 / p 2e-136 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 36% (drug 61%) | no trial data cached |
| Blood lactate dehydrogenase increased | 10 | 5.2 2.8–9.6ROR 5.2 · χ² 30 / p 3e-8 | 4.3 EB05 2.5 · IC025 +1.0 3/3 methods agree | Lab value / disease marker | serious PRR 5.1 | no trial data cached |
| Osteomyelitis | 11 | 5.0 2.8–9.1ROR 5.0 · χ² 32 / p 1e-8 | 4.2 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 467 | 19.9 18.3–21.6ROR 24.2 · χ² 8,420 / p <1e-300 | 19.8 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Anxiety | 180 | 5.2 4.5–6.0ROR 5.5 · χ² 616 / p 2e-136 | 5.1 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · ♀ 36% (drug 61%) | no trial data cached |
| Hypersensitivity (allergic reaction) | 155 | 6.9 5.9–8.0ROR 7.3 · χ² 784 / p 1e-172 | 6.8 EB05 5.9 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 · 76% consumer | no trial data cached |
| Asthma | 146 | 10.8 9.2–12.6ROR 11.4 · χ² 1,289 / p 2e-282 | 10.6 EB05 9.2 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.2 · ♀ 38% (drug 61%) | no trial data cached |
| Therapeutic product effect incomplete | 123 | 14.4 12.1–17.1ROR 15.1 · χ² 1,521 / p <1e-300 | 14.3 EB05 12.3 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 26.8 · ♀ 34% (drug 61%) | no trial data cached |
| Wheezing | 120 | 16.8 14.1–20.0ROR 17.6 · χ² 1,766 / p <1e-300 | 16.7 EB05 14.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.3 · ♀ 27% (drug 61%) | no trial data cached |
| Hypothyroidism | 116 | 30.2 25.3–36.1ROR 31.6 · χ² 3,236 / p <1e-300 | 29.9 EB05 25.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.0 · ♀ 27% (drug 61%) | no trial data cached |
| Obstructive airways disorder | 116 | 86.7 72.5–103.7ROR 90.8 · χ² 9,642 / p <1e-300 | 84.6 EB05 72.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 91.6 · ♀ 26% (drug 61%) | no trial data cached |
| Sleep disorder due to a general medical condition | 110 | 56.5 47.1–67.9ROR 59.0 · χ² 5,909 / p <1e-300 | 55.6 EB05 47.4 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 114.2 · ♀ 26% (drug 61%) | no trial data cached |
| Full blood count abnormal | 104 | 82.2 68.1–99.4ROR 85.7 · χ² 8,186 / p <1e-300 | 80.3 EB05 68.1 · IC025 +5.6 3/3 methods agree | Likely indication confounding term in indications | serious PRR 111.1 · ♀ 23% (drug 61%) | no trial data cached |
| Loss of personal independence in daily activities | 103 | 17.9 14.8–21.7ROR 18.6 · χ² 1,628 / p <1e-300 | 17.8 EB05 15.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 23.9 · ♀ 29% (drug 61%) | no trial data cached |
| Pulmonary embolism (lung blood clot) | 99 | 8.6 7.1–10.4ROR 8.9 · χ² 657 / p 4e-145 | 8.3 EB05 7.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · ♀ 15% (drug 61%) | no trial data cached |
| Lung disorder | 98 | 16.6 13.6–20.1ROR 17.2 · χ² 1,417 / p <1e-300 | 16.5 EB05 13.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 · ♀ 7% (drug 61%) | no trial data cached |
| Urticaria (hives) | 91 | 4.5 3.7–5.5ROR 4.6 · χ² 247 / p 5e-56 | 4.4 EB05 3.7 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 · ♀ 82% (drug 61%) | no trial data cached |
| Haemoptysis | 90 | 26.7 21.8–32.7ROR 27.6 · χ² 2,193 / p <1e-300 | 26.4 EB05 22.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 30.7 · ♀ 0% (drug 61%) | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Obstructive airways disorder — n=116, PRR 86.7
- Vasculitis — n=86, PRR 61.3
- Arteriosclerosis — n=68, PRR 60.0
- Sleep disorder due to a general medical condition — n=110, PRR 56.5
- Nodule — n=68, PRR 43.2
- Pulmonary fibrosis — n=90, PRR 39.1
- Hypothyroidism — n=116, PRR 30.2
- Haemoptysis — n=90, PRR 26.7
- Drug hypersensitivity — n=467, PRR 19.9
- Loss of personal independence in daily activities — n=103, PRR 17.9
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Penicillin V?
In FDA FAERS, the most frequently co-reported reaction terms for Penicillin V are drug hypersensitivity, anxiety, hypersensitivity, asthma, wheezing, hypothyroidism. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Penicillin V have an FDA boxed warning?
No. The FDA label retrieved for Penicillin V has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Penicillin V causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0151c742-7525-4707-af03-bd48d50cd586, effective 20251015; matched on
openfda.generic_name.exact:"PENICILLIN V POTASSIUM") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 93 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.