Drug · FAERS side-effect profile with label screen
Mannitol side effects: what 4,912 FDA adverse event reports show
Drug class
Osmotic Diuretic
FDA label (Established Pharmacologic Class)
Who reports
4,912 reports · 95% serious · 1,410 with death outcome · 44% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Mannitol Injection is indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure. Mannitol Injection is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. ( 1 ) • elevated intraocular pressure. ( 1 )
FDA label, Indications and Usage
What it is
Mannitol Injection, USP is a sterile, nonpyrogenic solution of mannitol in water for injection available in a fliptop vial for intravenous administration as an osmotic diuretic. The content and characteristics are as follows: Conc.
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 4Labeled (related wording) 6Reporting / coding artifact 3Lab value / disease marker 5Not in label — unassessed 22
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.
- 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. 277 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 |
|---|---|---|---|---|---|---|
| Fear | 430 | 68.8 62.8–75.4ROR 75.3 · χ² 28,245 / p <1e-300 | 67.5 EB05 62.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 55.6 | no trial data cached |
| Multi-organ failure | 276 | 68.2 60.8–76.6ROR 72.2 · χ² 17,939 / p <1e-300 | 66.9 EB05 60.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 | no trial data cached |
| Appendicitis | 132 | 61.5 51.9–72.8ROR 63.2 · χ² 7,685 / p <1e-300 | 60.1 EB05 52.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 37.2 · ♀ 0% (drug 44%) · 94% clinician | no trial data cached |
| Ventricular fibrillation | 147 | 57.1 48.6–67.0ROR 58.8 · χ² 7,941 / p <1e-300 | 56.0 EB05 48.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious PRR 34.1 · ♀ 5% (drug 44%) · 93% clinician | no trial data cached |
| Renal injury | 382 | 55.0 49.9–60.6ROR 59.6 · χ² 19,973 / p <1e-300 | 54.2 EB05 49.8 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.0 | no trial data cached |
| Anhedonia | 312 | 50.9 45.7–56.7ROR 54.3 · χ² 15,043 / p <1e-300 | 50.1 EB05 45.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 | no trial data cached |
| Cardiogenic shock | 153 | 46.3 39.5–54.1ROR 47.7 · χ² 6,661 / p <1e-300 | 45.5 EB05 39.8 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 · ♀ 8% (drug 44%) · 91% clinician | no trial data cached |
| Brain oedema | 111 | 37.9 31.5–45.5ROR 38.7 · χ² 3,913 / p <1e-300 | 37.3 EB05 31.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.9 · 95% clinician | no trial data cached |
| Injury | 495 | 30.1 27.7–32.7ROR 33.4 · χ² 13,850 / p <1e-300 | 29.9 EB05 27.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 | no trial data cached |
| Multiple organ dysfunction syndrome | 192 | 29.6 25.7–34.0ROR 30.7 · χ² 5,242 / p <1e-300 | 29.3 EB05 26.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 · ♀ 9% (drug 44%) · 95% clinician | no trial data cached |
| Stress | 463 | 27.7 25.3–30.2ROR 30.4 · χ² 11,831 / p <1e-300 | 27.5 EB05 25.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Incorrect route of product administration | 106 | 27.1 22.4–32.7ROR 27.7 · χ² 2,623 / p <1e-300 | 26.8 EB05 22.8 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious PRR 32.5 · ♀ 2% (drug 44%) · 97% clinician | no trial data cached |
| Bacterial infection | 117 | 27.1 22.6–32.4ROR 27.7 · χ² 2,894 / p <1e-300 | 26.8 EB05 23.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 4% (drug 44%) · 94% clinician | no trial data cached |
| Unevaluable event | 470 | 26.7 24.5–29.1ROR 29.4 · χ² 11,559 / p <1e-300 | 26.5 EB05 24.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 28.3 | no trial data cached |
| Ascites | 150 | 21.9 18.7–25.6ROR 22.5 · χ² 2,956 / p <1e-300 | 21.7 EB05 19.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 13.3 · ♀ 4% (drug 44%) · 93% clinician | no trial data cached |
| Hyperlipidaemia | 61 | 21.8 17.0–28.0ROR 22.1 · χ² 1,186 / p 3e-260 | 21.6 EB05 17.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.5 · ♀ 0% (drug 44%) · 97% clinician | no trial data cached |
| Neuralgia | 118 | 20.9 17.5–24.9ROR 21.4 · χ² 2,204 / p <1e-300 | 20.7 EB05 17.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.6 · ♀ 2% (drug 44%) · 97% clinician | no trial data cached |
| Renal impairment | 393 | 20.1 18.3–22.1ROR 21.8 · χ² 7,124 / p <1e-300 | 20.0 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Hypercholesterolaemia | 44 | 19.7 14.7–26.5ROR 19.9 · χ² 760 / p 1e-167 | 19.5 EB05 15.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · ♀ 0% (drug 44%) · 100% clinician | no trial data cached |
| Renal failure (kidney failure) | 592 | 19.0 17.6–20.5ROR 21.4 · χ² 10,080 / p <1e-300 | 18.9 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Blood urea increased | 74 | 18.8 15.0–23.6ROR 19.1 · χ² 1,228 / p 3e-269 | 18.7 EB05 15.4 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 12.1 · ♀ 22% (drug 44%) · 96% clinician | no trial data cached |
| End stage renal disease | 80 | 18.6 15.0–23.1ROR 18.9 · χ² 1,311 / p 2e-287 | 18.5 EB05 15.3 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.2 · ♀ 11% (drug 44%) | no trial data cached |
| Renal failure acute | 184 | 18.3 15.9–21.1ROR 19.0 · χ² 2,989 / p <1e-300 | 18.2 EB05 16.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 | no trial data cached |
| Hyponatraemia (low sodium) | 233 | 17.8 15.7–20.1ROR 18.6 · χ² 3,664 / p <1e-300 | 17.7 EB05 15.8 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.9 · ♀ 16% (drug 44%) · 94% clinician | no trial data cached |
| Blood test abnormal | 54 | 16.5 12.6–21.5ROR 16.7 · χ² 767 / p 4e-169 | 16.3 EB05 12.9 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 · ♀ 6% (drug 44%) · 96% clinician | no trial data cached |
| Aspiration | 41 | 16.2 11.9–22.0ROR 16.3 · χ² 568 / p 7e-126 | 16.0 EB05 12.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · ♀ 3% (drug 44%) · 100% clinician | no trial data cached |
| Ulcer | 60 | 16.1 12.5–20.8ROR 16.3 · χ² 834 / p 1e-183 | 16.0 EB05 12.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 · ♀ 0% (drug 44%) · 95% clinician | no trial data cached |
| Neutrophil count increased | 36 | 15.0 10.8–20.8ROR 15.1 · χ² 455 / p 3e-101 | 14.7 EB05 11.0 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 9.9 · 97% clinician | no trial data cached |
| Gout | 59 | 14.1 10.9–18.1ROR 14.2 · χ² 701 / p 9e-155 | 13.9 EB05 11.1 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 12.8 · ♀ 0% (drug 44%) · 98% clinician | no trial data cached |
| Lymphocyte count decreased | 58 | 14.0 10.9–18.1ROR 14.2 · χ² 688 / p 7e-152 | 13.8 EB05 11.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · 98% clinician | no trial data cached |
| Full blood count abnormal | 34 | 13.8 9.9–19.3ROR 13.9 · χ² 390 / p 4e-87 | 13.4 EB05 9.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 11.1 · ♀ 0% (drug 44%) · 100% clinician | no trial data cached |
| Emotional distress | 386 | 13.6 12.4–15.0ROR 14.7 · χ² 4,506 / p <1e-300 | 13.5 EB05 12.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Micturition urgency | 36 | 13.6 9.8–18.8ROR 13.7 · χ² 406 / p 1e-90 | 13.2 EB05 9.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · ♀ 0% (drug 44%) · 97% clinician | no trial data cached |
| Blood creatinine increased | 172 | 11.3 9.7–13.0ROR 11.6 · χ² 1,597 / p <1e-300 | 11.1 EB05 9.8 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · ♀ 19% (drug 44%) · 95% clinician | no trial data cached |
| Hyperkalaemia (high potassium) | 88 | 10.8 8.8–13.3ROR 11.0 · χ² 771 / p 5e-170 | 10.6 EB05 8.8 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 94% clinician | no trial data cached |
| Blood cholesterol increased | 110 | 10.1 8.4–12.1ROR 10.3 · χ² 892 / p 3e-196 | 9.9 EB05 8.4 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 9.2 · ♀ 6% (drug 44%) · 95% clinician | no trial data cached |
| Posterior reversible encephalopathy syndrome | 22 | 9.9 6.5–15.0ROR 9.9 · χ² 167 / p 2e-38 | 8.9 EB05 6.0 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 100% clinician | no trial data cached |
| Transaminases increased | 51 | 9.8 7.5–12.9ROR 9.9 · χ² 395 / p 4e-88 | 9.4 EB05 7.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 14% (drug 44%) · 96% clinician | no trial data cached |
| Sepsis (blood infection) | 256 | 9.8 8.7–11.1ROR 10.3 · χ² 2,024 / p <1e-300 | 9.7 EB05 8.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · ♀ 18% (drug 44%) · 94% clinician | no trial data cached |
| Ataxia | 27 | 9.7 6.6–14.1ROR 9.7 · χ² 201 / p 5e-46 | 8.9 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · 100% clinician | 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 |
|---|---|---|---|---|---|---|
| Pain | 616 | 4.3 4.0–4.6ROR 4.7 · χ² 1,589 / p <1e-300 | 4.3 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 | no trial data cached |
| Renal failure (kidney failure) | 592 | 19.0 17.6–20.5ROR 21.4 · χ² 10,080 / p <1e-300 | 18.9 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.5 | no trial data cached |
| Anxiety | 505 | 7.6 7.0–8.2ROR 8.3 · χ² 2,907 / p <1e-300 | 7.5 EB05 7.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Injury | 495 | 30.1 27.7–32.7ROR 33.4 · χ² 13,850 / p <1e-300 | 29.9 EB05 27.7 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.4 | no trial data cached |
| Unevaluable event | 470 | 26.7 24.5–29.1ROR 29.4 · χ² 11,559 / p <1e-300 | 26.5 EB05 24.5 · IC025 +4.5 3/3 methods agree | Reporting / coding artifact | serious PRR 28.3 | no trial data cached |
| Stress | 463 | 27.7 25.3–30.2ROR 30.4 · χ² 11,831 / p <1e-300 | 27.5 EB05 25.4 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Fear | 430 | 68.8 62.8–75.4ROR 75.3 · χ² 28,245 / p <1e-300 | 67.5 EB05 62.3 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 55.6 | no trial data cached |
| Death | 423 | 2.1 1.9–2.3ROR 2.2 · χ² 252 / p 5e-57 | 2.1 EB05 1.9 · IC025 +0.9 | Outcome field, not a reaction | serious PRR 1.3 | no trial data cached |
| Renal impairment | 393 | 20.1 18.3–22.1ROR 21.8 · χ² 7,124 / p <1e-300 | 20.0 EB05 18.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.6 | no trial data cached |
| Emotional distress | 386 | 13.6 12.4–15.0ROR 14.7 · χ² 4,506 / p <1e-300 | 13.5 EB05 12.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Renal injury | 382 | 55.0 49.9–60.6ROR 59.6 · χ² 19,973 / p <1e-300 | 54.2 EB05 49.8 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 33.0 | no trial data cached |
| Vomiting | 321 | 2.9 2.6–3.3ROR 3.1 · χ² 413 / p 3e-92 | 2.9 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Anhedonia | 312 | 50.9 45.7–56.7ROR 54.3 · χ² 15,043 / p <1e-300 | 50.1 EB05 45.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 33.6 | no trial data cached |
| Condition aggravated | 284 | 4.0 3.6–4.5ROR 4.2 · χ² 649 / p 1e-143 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · ♀ 17% (drug 44%) · 97% clinician | no trial data cached |
| Multi-organ failure | 276 | 68.2 60.8–76.6ROR 72.2 · χ² 17,939 / p <1e-300 | 66.9 EB05 60.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious PRR 40.8 | 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.
- Fear — n=430, PRR 68.8
- Multi-organ failure — n=276, PRR 68.2
- Appendicitis — n=132, PRR 61.5
- Ventricular fibrillation — n=147, PRR 57.1
- Anhedonia — n=312, PRR 50.9
- Cardiogenic shock — n=153, PRR 46.3
- Multiple organ dysfunction syndrome — n=192, PRR 29.6
- Stress — n=463, PRR 27.7
- Bacterial infection — n=117, PRR 27.1
- Ascites — n=150, PRR 21.9
✓ A hand-written Bradford Hill causality assessment exists for this drug: Mannitol ↔ Renal failure.
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 Mannitol?
In FDA FAERS, the most frequently co-reported reaction terms for Mannitol are pain, renal failure, anxiety, injury, stress, fear. 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 Mannitol have an FDA boxed warning?
No. The FDA label retrieved for Mannitol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Mannitol 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 8ad3145e-00e7-4412-b9a5-06f00f264f30, effective 20260421; matched on
openfda.generic_name.exact:"MANNITOL") - 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, 317 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.