Phosphorus side effects: what 1,116 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,116 reports · 87% serious · 348 with death outcome · 63% female
Used for
Condition listed above or as directed by the physician
Boxed warning
None in the current label
Causality screen of the 40 strongest signals
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. 145 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypercholesterolaemia | 165 | 329.7 286.0–380.2ROR 386.8 · χ² 52,833 / p <1e-300 | 312.2 EB05 274.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 226.7 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Folliculitis | 167 | 308.8 268.1–355.6ROR 362.9 · χ² 50,114 / p <1e-300 | 293.5 EB05 258.0 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 235.0 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Wound infection | 172 | 302.1 263.0–347.1ROR 357.0 · χ² 50,526 / p <1e-300 | 287.8 EB05 253.5 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 209.9 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Back injury | 170 | 299.7 260.6–344.7ROR 353.4 · χ² 49,541 / p <1e-300 | 285.5 EB05 251.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 257.1 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Helicobacter infection | 158 | 295.8 255.7–342.2ROR 344.4 · χ² 45,422 / p <1e-300 | 281.2 EB05 246.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 202.6 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Bursitis | 169 | 266.9 232.0–307.1ROR 314.4 · χ² 43,901 / p <1e-300 | 255.6 EB05 224.8 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 203.9 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Pemphigus | 173 | 265.2 230.9–304.4ROR 313.6 · χ² 44,651 / p <1e-300 | 254.1 EB05 223.9 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 172.6 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Taste disorder | 255 | 242.2 217.2–270.0ROR 313.6 · χ² 60,278 / p <1e-300 | 234.9 EB05 211.7 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.7 · ♀ 99% (drug 63%) · 93% clinician | no trial data cached |
| Synovitis | 182 | 191.4 167.4–218.8ROR 228.5 · χ² 33,961 / p <1e-300 | 185.8 EB05 164.2 · IC025 +6.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.6 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Obesity | 145 | 172.3 147.9–200.7ROR 197.9 · χ² 24,318 / p <1e-300 | 167.0 EB05 145.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 130.5 · ♀ 98% (drug 63%) · 98% clinician | no trial data cached |
| Pericarditis | 142 | 161.5 138.4–188.4ROR 184.9 · χ² 22,309 / p <1e-300 | 156.7 EB05 136.3 · IC025 +6.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 106.2 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Joint range of motion decreased | 113 | 160.2 134.4–190.9ROR 178.1 · χ² 17,577 / p <1e-300 | 154.7 EB05 132.2 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 133.3 · ♀ 98% (drug 63%) · 96% clinician | no trial data cached |
| Hand deformity | 109 | 157.8 131.9–188.8ROR 174.8 · χ² 16,699 / p <1e-300 | 152.4 EB05 129.8 · IC025 +6.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 112.0 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Epilepsy | 243 | 150.8 134.9–168.7ROR 192.5 · χ² 35,776 / p <1e-300 | 147.9 EB05 132.9 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.0 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Irritable bowel syndrome | 155 | 137.3 118.6–159.0ROR 159.3 · χ² 20,704 / p <1e-300 | 134.1 EB05 117.3 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 113.9 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 158 | 133.7 115.7–154.6ROR 155.6 · χ² 20,556 / p <1e-300 | 130.7 EB05 114.5 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 126.6 · ♀ 99% (drug 63%) · 98% clinician | no trial data cached |
| Fibromyalgia | 171 | 133.2 116.0–153.0ROR 157.2 · χ² 22,175 / p <1e-300 | 130.4 EB05 114.8 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 114.6 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Liver function test increased | 137 | 121.5 103.8–142.2ROR 138.3 · χ² 16,159 / p <1e-300 | 118.7 EB05 103.0 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 122.2 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Contraindicated product administered | 173 | 108.4 94.5–124.4ROR 128.1 · χ² 18,218 / p <1e-300 | 106.5 EB05 93.8 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 85.8 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Night sweats | 169 | 99.1 86.2–114.0ROR 116.6 · χ² 16,258 / p <1e-300 | 97.6 EB05 85.8 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 110.8 · ♀ 99% (drug 63%) · 97% clinician | no trial data cached |
| Type 2 diabetes mellitus | 173 | 96.7 84.3–111.0ROR 114.3 · χ² 16,237 / p <1e-300 | 95.3 EB05 83.9 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.8 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Impaired healing | 165 | 94.9 82.4–109.3ROR 111.2 · χ² 15,180 / p <1e-300 | 93.4 EB05 82.0 · IC025 +5.9 3/3 methods agree | Reporting / coding artifact | serious PRR 75.2 · ♀ 99% (drug 63%) · 98% clinician | no trial data cached |
| Gait inability | 163 | 93.0 80.6–107.2ROR 108.7 · χ² 14,689 / p <1e-300 | 91.6 EB05 80.4 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 75.8 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| Systemic lupus erythematosus | 172 | 91.8 80.0–105.4ROR 108.3 · χ² 15,306 / p <1e-300 | 90.5 EB05 79.7 · IC025 +5.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.7 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Wound | 133 | 90.3 77.0–106.0ROR 102.4 · χ² 11,616 / p <1e-300 | 88.8 EB05 76.8 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 70.5 · ♀ 100% (drug 63%) · 97% clinician | no trial data cached |
| C-reactive protein increased | 171 | 88.8 77.3–101.9ROR 104.6 · χ² 14,705 / p <1e-300 | 87.5 EB05 77.0 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious PRR 60.5 · ♀ 99% (drug 63%) · 98% clinician | no trial data cached |
| Incontinence | 49 | 87.3 66.4–114.9ROR 91.3 · χ² 4,078 / p <1e-300 | 84.2 EB05 66.2 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 77.1 · ♀ 96% (drug 63%) | no trial data cached |
| Psoriatic arthropathy | 175 | 82.1 71.6–94.1ROR 97.2 · χ² 13,906 / p <1e-300 | 81.1 EB05 71.5 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 67.8 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Osteoarthritis | 176 | 78.2 68.2–89.6ROR 92.6 · χ² 13,304 / p <1e-300 | 77.2 EB05 68.1 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.5 · ♀ 100% (drug 63%) · 98% clinician | no trial data cached |
| Neuroleptic malignant syndrome | 48 | 76.1 57.7–100.5ROR 79.5 · χ² 3,472 / p <1e-300 | 73.7 EB05 57.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.2 · ♀ 100% (drug 63%) | no trial data cached |
| Schizophrenia | 49 | 76.0 57.8–100.0ROR 79.4 · χ² 3,540 / p <1e-300 | 73.6 EB05 57.9 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 51.7 · ♀ 98% (drug 63%) | no trial data cached |
| Muscle rigidity | 47 | 74.2 56.0–98.2ROR 77.4 · χ² 3,309 / p <1e-300 | 71.8 EB05 56.2 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 54.7 · ♀ 100% (drug 63%) | no trial data cached |
| Therapeutic product effect decreased | 169 | 71.8 62.5–82.5ROR 84.5 · χ² 11,710 / p <1e-300 | 71.0 EB05 62.5 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious PRR 92.4 · ♀ 99% (drug 63%) · 97% clinician | no trial data cached |
| Liver injury | 91 | 71.0 58.3–86.4ROR 77.2 · χ² 6,191 / p <1e-300 | 69.7 EB05 58.5 · IC025 +5.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.3 · ♀ 100% (drug 63%) · 96% clinician | no trial data cached |
| Laryngitis | 39 | 67.7 49.7–92.2ROR 70.1 · χ² 2,490 / p <1e-300 | 65.4 EB05 49.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=39 · ♀ 100% (drug 63%) · 95% clinician | no trial data cached |
| Mydriasis | 46 | 67.7 51.0–89.8ROR 70.5 · χ² 2,946 / p <1e-300 | 65.7 EB05 51.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 57.4 · ♀ 100% (drug 63%) | no trial data cached |
| Red blood cell sedimentation rate increased | 39 | 66.3 48.7–90.3ROR 68.7 · χ² 2,436 / p <1e-300 | 64.1 EB05 48.9 · IC025 +4.6 3/3 methods agree | Lab value / disease marker | serious PRR 49.3 · ♀ 100% (drug 63%) · 95% clinician | no trial data cached |
| Paralysis | 49 | 64.3 48.9–84.6ROR 67.2 · χ² 2,981 / p <1e-300 | 62.6 EB05 49.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.7 · ♀ 100% (drug 63%) | no trial data cached |
| Hypoaesthesia oral | 51 | 63.8 48.8–83.5ROR 66.8 · χ² 3,084 / p <1e-300 | 62.2 EB05 49.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 76.7 · ♀ 96% (drug 63%) | no trial data cached |
| Autoimmune disorder | 32 | 63.0 44.8–88.7ROR 64.8 · χ² 1,886 / p <1e-300 | 60.6 EB05 45.0 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.2 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Paraesthesia (tingling/numbness) | 312 | 37.2 33.9–40.9ROR 51.3 · χ² 11,029 / p <1e-300 | 37.1 EB05 33.8 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.1 · ♀ 98% (drug 63%) · 91% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 304 | 38.2 34.7–42.0ROR 52.1 · χ² 11,030 / p <1e-300 | 38.0 EB05 34.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 40.0 · ♀ 97% (drug 63%) · 91% clinician | no trial data cached |
| Vomiting | 288 | 11.5 10.5–12.8ROR 15.2 · χ² 2,826 / p <1e-300 | 11.5 EB05 10.4 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 · ♀ 94% (drug 63%) | no trial data cached |
| Abdominal pain upper | 259 | 23.7 21.3–26.4ROR 30.6 · χ² 5,661 / p <1e-300 | 23.7 EB05 21.3 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.1 · ♀ 99% (drug 63%) · 94% clinician | no trial data cached |
| Taste disorder | 255 | 242.2 217.2–270.0ROR 313.6 · χ² 60,278 / p <1e-300 | 234.9 EB05 211.7 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 313.7 · ♀ 99% (drug 63%) · 93% clinician | no trial data cached |
| Drug intolerance | 251 | 49.1 44.0–54.8ROR 63.1 · χ² 11,809 / p <1e-300 | 48.8 EB05 44.0 · IC025 +5.3 3/3 methods agree | Reporting / coding artifact | serious PRR 52.4 · ♀ 99% (drug 63%) · 94% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 251 | 59.0 52.9–65.8ROR 75.8 · χ² 14,262 / p <1e-300 | 58.6 EB05 52.7 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.8 · ♀ 98% (drug 63%) · 93% clinician | no trial data cached |
| Asthenia (weakness) | 249 | 12.4 11.2–13.9ROR 15.7 · χ² 2,656 / p <1e-300 | 12.4 EB05 11.1 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.3 · ♀ 92% (drug 63%) | no trial data cached |
| Arthralgia (joint pain) | 246 | 11.2 10.0–12.5ROR 14.0 · χ² 2,310 / p <1e-300 | 11.1 EB05 10.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.1 · ♀ 97% (drug 63%) · 91% clinician | no trial data cached |
| Epilepsy | 243 | 150.8 134.9–168.7ROR 192.5 · χ² 35,776 / p <1e-300 | 147.9 EB05 132.9 · IC025 +6.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.0 · ♀ 100% (drug 63%) · 94% clinician | no trial data cached |
| Dizziness | 242 | 9.1 8.2–10.2ROR 11.4 · χ² 1,787 / p <1e-300 | 9.0 EB05 8.1 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 · ♀ 93% (drug 63%) | no trial data cached |
| Depression | 237 | 19.5 17.4–21.8ROR 24.5 · χ² 4,184 / p <1e-300 | 19.5 EB05 17.5 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.8 · ♀ 99% (drug 63%) · 94% clinician | no trial data cached |
| Sleep disorder | 229 | 61.7 55.0–69.3ROR 77.4 · χ² 13,613 / p <1e-300 | 61.2 EB05 54.8 · IC025 +5.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.8 · ♀ 99% (drug 63%) · 94% clinician | no trial data cached |
| Confusional state (confusion) | 228 | 26.5 23.6–29.8ROR 33.0 · χ² 5,604 / p <1e-300 | 26.4 EB05 23.7 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.2 · ♀ 98% (drug 63%) · 94% clinician | no trial data cached |
| Product use in unapproved indication | 217 | 16.7 14.8–18.8ROR 20.5 · χ² 3,223 / p <1e-300 | 16.7 EB05 14.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | serious PRR 24.3 · ♀ 99% (drug 63%) · 93% 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.
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 Phosphorus?
In FDA FAERS, the most frequently co-reported reaction terms for Phosphorus are paraesthesia, hypoaesthesia, vomiting, abdominal pain upper, taste disorder, gastrooesophageal reflux disease. 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 Phosphorus have an FDA boxed warning?
No. The FDA label retrieved for Phosphorus has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Phosphorus 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 1a4970b4-8c23-8425-e063-6294a90a5d93, effective 20240607; matched on
openfda.generic_name.exact:"PHOSPHORUS") - PubChem CID 5462309 description ()
- 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, 185 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.