Drug · FAERS side-effect profile with label screen
Phosphoric Acid side effects: what 238 FDA adverse event reports show
Drug class
Not stated in label
Who reports
238 reports · 99% serious · 47 with death outcome · 89% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Condition listed above or as directed by the physician
FDA label, Indications and Usage
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 26 strongest signals
Reporting / coding artifact 2Lab value / disease marker 2No label text to screen 22
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 2 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 |
|---|---|---|---|---|---|---|
| Blood calcium decreased | 105 | 827.7 716.5–956.0ROR 1,480.3 · χ² 85,105 / p <1e-300 | 712.6 EB05 605.4 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious PRR 598.0 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 114 | 579.3 507.0–662.0ROR 1,111.1 · χ² 64,863 / p <1e-300 | 524.6 EB05 448.6 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 381.8 | no trial data cached |
| Sedation | 94 | 318.8 272.3–373.3ROR 526.3 · χ² 29,393 / p <1e-300 | 298.4 EB05 251.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 255.3 | no trial data cached |
| Depressed level of consciousness | 102 | 228.2 197.0–264.4ROR 398.7 · χ² 22,833 / p <1e-300 | 218.4 EB05 185.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.3 | no trial data cached |
| Hypomagnesaemia | 34 | 216.4 158.5–295.6ROR 252.3 · χ² 7,064 / p <1e-300 | 192.7 EB05 144.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · 100% clinician | no trial data cached |
| Bladder disorder | 23 | 204.1 138.3–301.2ROR 225.8 · χ² 4,439 / p <1e-300 | 174.4 EB05 122.4 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=23 | no trial data cached |
| Cognitive disorder | 105 | 199.3 172.7–230.0ROR 355.9 · χ² 20,519 / p <1e-300 | 192.0 EB05 163.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 162.5 | no trial data cached |
| Mouth ulceration | 33 | 138.4 100.8–190.1ROR 160.6 · χ² 4,364 / p <1e-300 | 128.1 EB05 95.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 106.8 · 100% clinician | no trial data cached |
| Mobility decreased | 111 | 136.8 119.4–156.7ROR 255.4 · χ² 14,851 / p <1e-300 | 133.5 EB05 113.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.5 | no trial data cached |
| Balance disorder | 130 | 132.5 118.0–148.8ROR 290.8 · χ² 16,878 / p <1e-300 | 129.8 EB05 112.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.2 | no trial data cached |
| Hand deformity | 19 | 128.1 83.2–197.3ROR 139.1 · χ² 2,269 / p <1e-300 | 113.6 EB05 76.9 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.1 | no trial data cached |
| Mucosal inflammation | 33 | 111.7 81.4–153.3ROR 129.5 · χ² 3,510 / p <1e-300 | 104.9 EB05 78.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.2 · 100% clinician | no trial data cached |
| Sciatica | 20 | 111.2 73.1–169.2ROR 121.3 · χ² 2,075 / p <1e-300 | 100.7 EB05 68.8 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.1 | no trial data cached |
| Deformity | 11 | 103.5 58.1–184.4ROR 108.5 · χ² 1,016 / p 3e-223 | 88.1 EB05 52.5 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.0 | no trial data cached |
| Candida infection (yeast infection) | 19 | 100.4 65.2–154.6ROR 109.1 · χ² 1,772 / p <1e-300 | 91.4 EB05 61.8 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 84.0 | no trial data cached |
| Nervous system disorder | 30 | 84.5 60.5–118.1ROR 96.5 · χ² 2,393 / p <1e-300 | 80.2 EB05 58.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.0 · 100% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 34 | 65.3 47.8–89.2ROR 76.0 · χ² 2,092 / p <1e-300 | 63.1 EB05 47.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · 100% clinician | no trial data cached |
| Neutrophil count decreased | 30 | 65.3 46.7–91.2ROR 74.6 · χ² 1,838 / p <1e-300 | 62.8 EB05 46.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious PRR 44.2 · 100% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 33 | 61.5 44.8–84.4ROR 71.2 · χ² 1,906 / p <1e-300 | 59.4 EB05 44.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.3 · 100% clinician | no trial data cached |
| Contraindicated product administered | 19 | 55.5 36.1–85.5ROR 60.3 · χ² 964 / p 5e-212 | 52.7 EB05 35.7 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 40.3 | no trial data cached |
| Constipation | 136 | 55.4 49.6–61.9ROR 127.9 · χ² 7,282 / p <1e-300 | 55.0 EB05 47.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.1 · 90% clinician | no trial data cached |
| Toxicity to various agents | 79 | 41.5 34.6–49.7ROR 61.6 · χ² 3,105 / p <1e-300 | 41.1 EB05 34.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.9 · 92% clinician | no trial data cached |
| Dementia | 13 | 41.1 24.3–69.8ROR 43.5 · χ² 470 / p 1e-104 | 39.0 EB05 24.2 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.8 | no trial data cached |
| Drug abuse | 31 | 32.7 23.5–45.4ROR 37.4 · χ² 923 / p 4e-203 | 32.1 EB05 23.7 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.3 · 97% clinician | no trial data cached |
| Injection site reaction | 19 | 24.4 15.9–37.6ROR 26.4 · χ² 405 / p 3e-90 | 23.9 EB05 16.1 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.5 | no trial data cached |
| Rheumatoid arthritis | 26 | 20.3 14.1–29.1ROR 22.6 · χ² 459 / p 3e-102 | 20.0 EB05 14.2 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.4 | 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 |
|---|---|---|---|---|---|---|
| Constipation | 136 | 55.4 49.6–61.9ROR 127.9 · χ² 7,282 / p <1e-300 | 55.0 EB05 47.6 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.1 · 90% clinician | no trial data cached |
| Balance disorder | 130 | 132.5 118.0–148.8ROR 290.8 · χ² 16,878 / p <1e-300 | 129.8 EB05 112.1 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 124.2 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 114 | 579.3 507.0–662.0ROR 1,111.1 · χ² 64,863 / p <1e-300 | 524.6 EB05 448.6 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 381.8 | no trial data cached |
| Mobility decreased | 111 | 136.8 119.4–156.7ROR 255.4 · χ² 14,851 / p <1e-300 | 133.5 EB05 113.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.5 | no trial data cached |
| Cognitive disorder | 105 | 199.3 172.7–230.0ROR 355.9 · χ² 20,519 / p <1e-300 | 192.0 EB05 163.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 162.5 | no trial data cached |
| Blood calcium decreased | 105 | 827.7 716.5–956.0ROR 1,480.3 · χ² 85,105 / p <1e-300 | 712.6 EB05 605.4 · IC025 +7.1 3/3 methods agree | Lab value / disease marker | serious PRR 598.0 | no trial data cached |
| Depressed level of consciousness | 102 | 228.2 197.0–264.4ROR 398.7 · χ² 22,833 / p <1e-300 | 218.4 EB05 185.1 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 136.3 | no trial data cached |
| Sedation | 94 | 318.8 272.3–373.3ROR 526.3 · χ² 29,393 / p <1e-300 | 298.4 EB05 251.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 255.3 | no trial data cached |
| Toxicity to various agents | 79 | 41.5 34.6–49.7ROR 61.6 · χ² 3,105 / p <1e-300 | 41.1 EB05 34.0 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 24.9 · 92% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 34 | 65.3 47.8–89.2ROR 76.0 · χ² 2,092 / p <1e-300 | 63.1 EB05 47.2 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.7 · 100% clinician | no trial data cached |
| Hypomagnesaemia | 34 | 216.4 158.5–295.6ROR 252.3 · χ² 7,064 / p <1e-300 | 192.7 EB05 144.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 129.7 · 100% clinician | no trial data cached |
| Productive cough (cough with phlegm) | 33 | 61.5 44.8–84.4ROR 71.2 · χ² 1,906 / p <1e-300 | 59.4 EB05 44.3 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 53.3 · 100% clinician | no trial data cached |
| Mucosal inflammation | 33 | 111.7 81.4–153.3ROR 129.5 · χ² 3,510 / p <1e-300 | 104.9 EB05 78.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.2 · 100% clinician | no trial data cached |
| Mouth ulceration | 33 | 138.4 100.8–190.1ROR 160.6 · χ² 4,364 / p <1e-300 | 128.1 EB05 95.5 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 106.8 · 100% clinician | no trial data cached |
| Drug abuse | 31 | 32.7 23.5–45.4ROR 37.4 · χ² 923 / p 4e-203 | 32.1 EB05 23.7 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 19.3 · 97% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
✓ A hand-written Bradford Hill causality assessment exists for this drug: Zoledronic acid (bisphosphonates) ↔ Osteonecrosis of the jaw.
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 Phosphoric Acid?
In FDA FAERS, the most frequently co-reported reaction terms for Phosphoric Acid are constipation, balance disorder, orthostatic hypotension, mobility decreased, cognitive disorder, blood calcium decreased. 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 Phosphoric Acid have an FDA boxed warning?
No. The FDA label retrieved for Phosphoric Acid has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Phosphoric Acid 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 1a494ef4-89fd-92c2-e063-6394a90a7333, effective 20240607; matched on
openfda.generic_name.exact:"PHOSPHORIC ACID") - 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, 28 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.