Drug · FAERS side-effect profile with label screen
Ammonium Lactate side effects: what 2,118 FDA adverse event reports show
Drug class
alpha-Hydroxy Acid
FDA label (Established Pharmacologic Class)
Who reports
2,118 reports · 55% serious · 175 with death outcome · 59% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Ammonium Lactate Cream, 12% is indicated for the treatment of ichthyosis vulgaris and xerosis.
FDA label, Indications and Usage
What it is
DESCRIPTION * Ammonium Lactate Cream, 12% specially formulates 12% lactic acid, as ammonium lactate to provide a cream pH of 4.5 to 5.5. Ammonium Lactate Cream, 12% also contains cetyl alcohol.
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
Reporting / coding artifact 4Lab value / disease marker 1No label text to screen 35
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. 84 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 55 | 29.6 22.8–38.5ROR 30.4 · χ² 1,490 / p <1e-300 | 29.3 EB05 23.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.9 | no trial data cached |
| Economic problem | 37 | 23.8 17.3–32.8ROR 24.2 · χ² 785 / p 6e-173 | 23.5 EB05 17.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 27.2 · ♀ 25% (drug 59%) | no trial data cached |
| Anhedonia | 52 | 19.5 14.9–25.5ROR 19.9 · χ² 892 / p 3e-196 | 19.3 EB05 15.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 | no trial data cached |
| Chronic kidney disease | 127 | 16.4 13.9–19.4ROR 17.4 · χ² 1,827 / p <1e-300 | 16.3 EB05 14.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 | no trial data cached |
| Renal tubular necrosis | 12 | 12.1 6.9–21.3ROR 12.2 · χ² 111 / p 3e-26 | 10.4 EB05 5.7 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 | no trial data cached |
| Sleep disorder due to a general medical condition | 19 | 11.6 7.4–18.2ROR 11.7 · χ² 174 / p 4e-40 | 10.7 EB05 6.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | – | no trial data cached |
| Decreased activity | 12 | 11.1 6.3–19.5ROR 11.2 · χ² 100 / p 7e-24 | 9.4 EB05 5.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.0 | no trial data cached |
| Nephropathy | 10 | 10.6 5.7–19.6ROR 10.6 · χ² 77 / p 8e-19 | 8.4 EB05 4.5 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.8 | no trial data cached |
| Osteopenia | 15 | 9.7 5.9–16.1ROR 9.8 · χ² 109 / p 8e-26 | 8.3 EB05 5.1 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.4 | no trial data cached |
| Impaired quality of life | 14 | 9.6 5.7–16.2ROR 9.7 · χ² 100 / p 8e-24 | 8.1 EB05 4.9 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | no trial data cached |
| Acute respiratory failure | 18 | 9.3 5.9–14.8ROR 9.4 · χ² 125 / p 2e-29 | 8.1 EB05 5.2 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.8 | no trial data cached |
| Dermatitis atopic | 44 | 8.7 6.5–11.7ROR 8.9 · χ² 294 / p 4e-66 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Hyperlipidaemia | 10 | 8.3 4.5–15.3ROR 8.3 · χ² 57 / p 2e-14 | 6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Product dose omission in error | 22 | 8.1 5.4–12.3ROR 8.2 · χ² 130 / p 2e-30 | 7.2 EB05 4.9 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Bone density decreased | 25 | 7.8 5.3–11.5ROR 7.9 · χ² 142 / p 5e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.8 · ♀ 28% (drug 59%) | no trial data cached |
| Renal failure (kidney failure) | 100 | 7.4 6.1–9.0ROR 7.7 · χ² 550 / p 5e-122 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Skin fissures | 14 | 7.3 4.4–12.4ROR 7.4 · χ² 70 / p 2e-17 | 6.1 EB05 3.8 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Osteoporosis | 29 | 7.0 4.9–10.0ROR 7.1 · χ² 143 / p 4e-33 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Irritable bowel syndrome | 15 | 7.0 4.2–11.5ROR 7.0 · χ² 71 / p 2e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.4 | no trial data cached |
| Sciatica | 11 | 6.9 3.8–12.4ROR 6.9 · χ² 49 / p 1e-12 | 5.5 EB05 3.3 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.1 | no trial data cached |
| Foot fracture | 13 | 6.8 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.5 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Gout | 12 | 6.6 3.8–11.6ROR 6.6 · χ² 52 / p 3e-13 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.7 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 91 | 5.9 4.8–7.2ROR 6.1 · χ² 369 / p 1e-82 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Application site pain | 13 | 5.8 3.4–10.1ROR 5.9 · χ² 48 / p 3e-12 | 4.9 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 | no trial data cached |
| Dermatitis | 12 | 5.7 3.3–10.1ROR 5.8 · χ² 42 / p 4e-11 | 4.8 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.1 | no trial data cached |
| Cold sweat | 10 | 5.6 3.0–10.4ROR 5.6 · χ² 33 / p 4e-9 | 4.6 EB05 2.7 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| Renal injury | 17 | 5.6 3.5–9.0ROR 5.6 · χ² 60 / p 5e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Emotional distress | 64 | 5.2 4.1–6.6ROR 5.3 · χ² 215 / p 6e-49 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Pulmonary hypertension | 11 | 5.2 2.9–9.4ROR 5.2 · χ² 33 / p 4e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.5 | no trial data cached |
| Glaucoma | 10 | 5.1 2.8–9.5ROR 5.2 · χ² 29 / p 3e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.8 | no trial data cached |
| Dyspnoea exertional | 19 | 5.0 3.2–7.8ROR 5.0 · χ² 57 / p 2e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Eye pain | 25 | 4.5 3.0–6.6ROR 4.5 · χ² 64 / p 5e-16 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 80% consumer | no trial data cached |
| Dry skin | 57 | 4.3 3.3–5.5ROR 4.4 · χ² 141 / p 7e-33 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Limb discomfort | 13 | 4.2 2.4–7.1ROR 4.2 · χ² 28 / p 6e-8 | 3.7 EB05 2.3 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.1 | no trial data cached |
| Skin exfoliation | 33 | 3.9 2.8–5.5ROR 4.0 · χ² 69 / p 4e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Application site erythema | 10 | 3.8 2.0–7.0ROR 3.8 · χ² 18 / p 1e-5 | 3.3 EB05 1.9 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious n=1 | no trial data cached |
| Coronary artery disease | 11 | 3.6 2.0–6.4ROR 3.6 · χ² 18 / p 1e-5 | 3.2 EB05 1.9 · IC025 +0.7 | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Eczema | 18 | 3.5 2.2–5.6ROR 3.6 · χ² 30 / p 2e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Therapeutic response shortened | 10 | 3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Surgery | 18 | 3.1 1.9–4.9ROR 3.1 · χ² 23 / p 7e-7 | 2.9 EB05 2.0 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.1 | 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 |
|---|---|---|---|---|---|---|
| Chronic kidney disease | 127 | 16.4 13.9–19.4ROR 17.4 · χ² 1,827 / p <1e-300 | 16.3 EB05 14.1 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 17.4 | no trial data cached |
| Renal failure (kidney failure) | 100 | 7.4 6.1–9.0ROR 7.7 · χ² 550 / p 5e-122 | 7.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 91 | 5.9 4.8–7.2ROR 6.1 · χ² 369 / p 1e-82 | 5.8 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Emotional distress | 64 | 5.2 4.1–6.6ROR 5.3 · χ² 215 / p 6e-49 | 5.0 EB05 4.1 · IC025 +1.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 | no trial data cached |
| Dry skin | 57 | 4.3 3.3–5.5ROR 4.4 · χ² 141 / p 7e-33 | 4.2 EB05 3.3 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| End stage renal disease | 55 | 29.6 22.8–38.5ROR 30.4 · χ² 1,490 / p <1e-300 | 29.3 EB05 23.3 · IC025 +4.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.9 | no trial data cached |
| Anhedonia | 52 | 19.5 14.9–25.5ROR 19.9 · χ² 892 / p 3e-196 | 19.3 EB05 15.3 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.2 | no trial data cached |
| Dermatitis atopic | 44 | 8.7 6.5–11.7ROR 8.9 · χ² 294 / p 4e-66 | 8.2 EB05 6.3 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Injection site pain (pain where injected) | 43 | 1.4 1.0–1.9ROR 1.4 · χ² 5 / p 0.016 | 1.4 EB05 1.1 · IC025 -0.0 PRR-only: not supported by EBGM or IC | No label text to screen label has no adverse-reaction text | serious PRR 2.2 | no trial data cached |
| Economic problem | 37 | 23.8 17.3–32.8ROR 24.2 · χ² 785 / p 6e-173 | 23.5 EB05 17.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 27.2 · ♀ 25% (drug 59%) | no trial data cached |
| Psoriasis | 35 | 2.6 1.9–3.7ROR 2.7 · χ² 35 / p 2e-9 | 2.6 EB05 1.9 · IC025 +0.8 | No label text to screen label has no adverse-reaction text | serious PRR 2.8 | no trial data cached |
| Skin exfoliation | 33 | 3.9 2.8–5.5ROR 4.0 · χ² 69 / p 4e-17 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.8 | no trial data cached |
| Osteoporosis | 29 | 7.0 4.9–10.0ROR 7.1 · χ² 143 / p 4e-33 | 6.4 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 7.8 | no trial data cached |
| Eye pain | 25 | 4.5 3.0–6.6ROR 4.5 · χ² 64 / p 5e-16 | 4.2 EB05 3.0 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 · 80% consumer | no trial data cached |
| Bone density decreased | 25 | 7.8 5.3–11.5ROR 7.9 · χ² 142 / p 5e-33 | 7.0 EB05 4.9 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.8 · ♀ 28% (drug 59%) | 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 Ammonium Lactate?
In FDA FAERS, the most frequently co-reported reaction terms for Ammonium Lactate are chronic kidney disease, renal failure, acute kidney injury, emotional distress, dry skin, end stage renal 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 Ammonium Lactate have an FDA boxed warning?
No. The FDA label retrieved for Ammonium Lactate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Ammonium Lactate 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 030e8bd1-0ff3-479f-aa77-16fab701a111, effective 20260414; matched on
openfda.generic_name.exact:"AMMONIUM LACTATE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 124 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.