Lithium Bromatum side effects: what 25,059 FDA adverse event reports show

Lithium Bromatum · Lithium · 1,221 reaction terms · 111,487 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Lithium

openFDA label

Who reports

25,059 reports · 78% serious · 2,094 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Dosage Adults: Take 20 drops on the toungue or in water two to three times daily. Children receive 1/2 of the adult amount.

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 40 strongest signals

Lab value / disease marker 5No label text to screen 35

What the badges mean

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,181 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Hypokinetic dysarthria	16	1,884.7 775.4–4,580.9ROR 1,885.9 · calibrated p 2e-15 ✓	340.3 EB05 222.1 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=16	no trial arm names this drug
Paroxysmal perceptual alteration	25	589.0 352.6–983.9ROR 589.6 · calibrated p 3e-13 ✓	272.4 EB05 194.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25 · ♀ 36% (drug 58%) · 100% clinician	no trial arm names this drug
Total lung capacity increased	97	462.3 360.7–592.6ROR 464.1 · calibrated p 3e-13 ✓	280.2 EB05 236.5 · IC025 +6.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=97 · ♀ 100% (drug 58%) · 94% clinician	no trial arm names this drug
Nephrogenic diabetes insipidus	304	301.3 264.4–343.4ROR 305.0 · calibrated p 1e-11 ✓	217.9 EB05 198.1 · IC025 +7.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=302 · 97% clinician	no trial arm names this drug
Dystonic tremor	17	203.2 119.5–345.3ROR 203.3 · calibrated p 4e-9 ✓	138.2 EB05 91.4 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=17	no trial arm names this drug
Asthma-chronic obstructive pulmonary disease overlap syndrome	97	191.8 153.8–239.1ROR 192.5 · calibrated p 9e-10 ✓	151.2 EB05 127.6 · IC025 +6.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=97 · ♀ 100% (drug 58%) · 94% clinician	no trial arm names this drug
Delusion of grandeur	82	187.8 147.8–238.6ROR 188.4 · calibrated p 1e-9 ✓	147.9 EB05 123.0 · IC025 +6.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=82 · ♀ 17% (drug 58%)	no trial arm names this drug
Antipsychotic drug level below therapeutic	123	180.1 148.3–218.9ROR 181.0 · calibrated p 1e-9 ✓	144.7 EB05 124.5 · IC025 +6.2 3/3 methods agree	Lab value / disease marker	serious n=114 · ♀ 22% (drug 58%)	no trial arm names this drug
Action tremor	25	157.4 102.6–241.3ROR 157.5 · calibrated p 1e-8 ✓	120.4 EB05 85.7 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25 · 100% clinician	no trial arm names this drug
Schizoaffective disorder bipolar type	27	110.8 74.1–165.5ROR 110.9 · calibrated p 2e-7 ✓	91.6 EB05 66.1 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=27	no trial arm names this drug
Antipsychotic drug level above therapeutic	104	109.7 89.4–134.5ROR 110.1 · calibrated p 7e-8 ✓	95.3 EB05 80.9 · IC025 +5.7 3/3 methods agree	Lab value / disease marker	serious n=90 · 91% clinician	no trial arm names this drug
Camptocormia	27	106.5 71.4–159.0ROR 106.6 · calibrated p 2e-7 ✓	88.7 EB05 64.0 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25 · ♀ 100% (drug 58%) · 100% clinician	no trial arm names this drug
Decreased eye contact	32	98.8 68.5–142.6ROR 98.9 · calibrated p 3e-7 ✓	84.1 EB05 62.3 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=32 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Rebound psychosis	21	91.6 58.4–143.8ROR 91.7 · calibrated p 8e-7 ✓	77.0 EB05 53.1 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=21	no trial arm names this drug
Grandiosity	35	89.1 62.9–126.2ROR 89.2 · calibrated p 6e-7 ✓	77.2 EB05 58.0 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=34	no trial arm names this drug
Postural tremor	27	86.3 58.1–128.3ROR 86.4 · calibrated p 9e-7 ✓	74.3 EB05 53.6 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=27 · 100% clinician	no trial arm names this drug
Failure to suspend medication	19	84.7 52.8–135.8ROR 84.7 · calibrated p 1e-6 ✓	71.6 EB05 48.4 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=19	no trial arm names this drug
Hypomania	334	83.3 74.5–93.2ROR 84.4 · calibrated p 4e-7 ✓	75.4 EB05 68.9 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=315 · ♀ 80% (drug 58%)	no trial arm names this drug
Adulterated product	17	81.0 49.2–133.3ROR 81.1 · calibrated p 2e-6 ✓	68.4 EB05 45.2 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=17	no trial arm names this drug
Oppositional defiant disorder	35	80.4 56.8–113.7ROR 80.5 · calibrated p 1e-6 ✓	70.6 EB05 53.1 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=35 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Schizoaffective disorder	157	80.3 68.2–94.5ROR 80.8 · calibrated p 6e-7 ✓	72.6 EB05 63.6 · IC025 +5.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=156	no trial arm names this drug
Antipsychotic drug level increased	241	78.3 68.6–89.3ROR 79.0 · calibrated p 7e-7 ✓	71.2 EB05 64.0 · IC025 +5.8 3/3 methods agree	Lab value / disease marker	serious n=220	no trial arm names this drug
Oscillopsia	21	73.4 47.0–114.6ROR 73.4 · calibrated p 3e-6 ✓	63.7 EB05 44.0 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=19 · 100% clinician	no trial arm names this drug
Antipsychotic drug level decreased	41	69.8 50.8–96.1ROR 70.0 · calibrated p 3e-6 ✓	62.7 EB05 48.2 · IC025 +4.7 3/3 methods agree	Lab value / disease marker	serious n=32 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Pleurothotonus	62	61.0 47.1–78.9ROR 61.2 · calibrated p 5e-6 ✓	55.9 EB05 45.2 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=61 · ♀ 100% (drug 58%) · 100% clinician	no trial arm names this drug
Hyperparathyroidism	134	58.2 48.8–69.3ROR 58.5 · calibrated p 6e-6 ✓	54.0 EB05 46.7 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=131 · ♀ 83% (drug 58%) · 90% clinician	no trial arm names this drug
Pressure of speech	41	56.3 41.0–77.2ROR 56.3 · calibrated p 1e-5 ✓	51.5 EB05 39.6 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=40	no trial arm names this drug
Bipolar ii disorder	22	54.5 35.4–83.9ROR 54.5 · calibrated p 2e-5 ✓	49.1 EB05 34.2 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=20	no trial arm names this drug
Soft tissue injury	45	52.8 39.1–71.3ROR 52.9 · calibrated p 1e-5 ✓	48.7 EB05 37.9 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=45 · ♀ 100% (drug 58%)	no trial arm names this drug
Bipolar i disorder	119	48.1 40.0–57.8ROR 48.3 · calibrated p 2e-5 ✓	45.2 EB05 38.7 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=109	no trial arm names this drug
Post-traumatic neck syndrome	44	47.8 35.3–64.8ROR 47.9 · calibrated p 3e-5 ✓	44.4 EB05 34.5 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=44 · ♀ 100% (drug 58%)	no trial arm names this drug
Neuroleptic malignant syndrome	620	46.0 42.5–49.8ROR 47.1 · calibrated p 2e-5 ✓	43.6 EB05 40.8 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 32.4	no trial arm names this drug
Oromandibular dystonia	37	45.2 32.5–62.9ROR 45.3 · calibrated p 4e-5 ✓	42.0 EB05 31.9 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=35	no trial arm names this drug
Echolalia	16	44.0 26.6–72.7ROR 44.0 · calibrated p 8e-5 ✓	40.0 EB05 26.1 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=16	no trial arm names this drug
Diabetes insipidus	121	44.0 36.6–52.8ROR 44.2 · calibrated p 3e-5 ✓	41.5 EB05 35.7 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=119	no trial arm names this drug
Somatic symptom disorder	54	44.0 33.4–57.8ROR 44.0 · calibrated p 4e-5 ✓	41.2 EB05 32.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=47 · ♀ 100% (drug 58%)	no trial arm names this drug
Mania	781	41.7 38.9–44.8ROR 43.0 · calibrated p 3e-5 ✓	39.7 EB05 37.4 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 31.2	no trial arm names this drug
Flight of ideas	25	41.6 27.9–62.2ROR 41.7 · calibrated p 8e-5 ✓	38.6 EB05 27.5 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=25	no trial arm names this drug
Disinhibition	76	41.4 32.9–52.1ROR 41.5 · calibrated p 5e-5 ✓	39.1 EB05 32.2 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=76 · ♀ 0% (drug 58%)	no trial arm names this drug
Lymphocyte count abnormal	53	41.2 31.2–54.2ROR 41.2 · calibrated p 6e-5 ✓	38.7 EB05 30.8 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious n=53 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug

Trial evidence (ClinicalTrials.gov)

No completed trial with posted adverse-event results was found on ClinicalTrials.gov for Lithium Bromatum (searched LITHIUM BROMATUM).

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 ineffective (drug did not work)	2,297	1.5 1.4–1.5ROR 1.5 · calibrated p 0.646	1.5 EB05 1.4 · IC025 +0.5	Reporting / coding artifact	serious PRR 2.3	no trial arm names this drug
Toxicity to various agents	2,267	11.4 11.0–11.9ROR 12.5 · calibrated p 0.014 ✓	11.3 EB05 10.9 · IC025 +3.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.5 · 92% clinician	no trial arm names this drug
Off label use (used outside approved label)	1,604	1.5 1.5–1.6ROR 1.6 · calibrated p 0.697	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	serious PRR 1.7	no trial arm names this drug
Drug interaction	1,582	8.4 8.0–8.8ROR 8.9 · calibrated p 0.047 ✓	8.3 EB05 8.0 · IC025 +3.0 3/3 methods agree	Reporting / coding artifact	serious PRR 6.4	no trial arm names this drug
Tremor (shaking)	1,509	7.7 7.3–8.0ROR 8.1 · calibrated p 0.065	7.6 EB05 7.3 · IC025 +2.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0	no trial arm names this drug
Nausea	1,406	1.5 1.4–1.6ROR 1.5 · calibrated p 0.655	1.5 EB05 1.4 · IC025 +0.5	No label text to screen label has no adverse-reaction text	serious PRR 1.6	no trial arm names this drug
Weight increased (weight gain)	1,189	4.5 4.2–4.7ROR 4.7 · calibrated p 0.275	4.5 EB05 4.2 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.7	no trial arm names this drug
Fatigue (tiredness)	1,082	1.2 1.1–1.2ROR 1.2 · calibrated p 0.422	1.2 EB05 1.1 · IC025 +0.1	No label text to screen label has no adverse-reaction text	serious PRR 1.2	no trial arm names this drug
Vomiting	1,069	1.9 1.8–2.0ROR 2.0 · calibrated p 0.917	1.9 EB05 1.8 · IC025 +0.8	No label text to screen label has no adverse-reaction text	serious PRR 1.8	no trial arm names this drug
Depression	1,006	3.7 3.5–3.9ROR 3.8 · calibrated p 0.416	3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.1	no trial arm names this drug
Anxiety	990	2.9 2.7–3.1ROR 3.0 · calibrated p 0.630	2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 2.5	no trial arm names this drug
Somnolence (drowsiness)	936	3.9 3.7–4.2ROR 4.0 · calibrated p 0.374	3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.8	no trial arm names this drug
Insomnia (trouble sleeping)	930	2.9 2.7–3.1ROR 3.0 · calibrated p 0.627	2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 2.8	no trial arm names this drug
Suicidal ideation (thoughts of suicide)	914	8.4 7.9–9.0ROR 8.7 · calibrated p 0.051	8.3 EB05 7.9 · IC025 +2.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 6.3	no trial arm names this drug
Dizziness	842	1.4 1.3–1.5ROR 1.4 · calibrated p 0.596	1.4 EB05 1.3 · IC025 +0.4	No label text to screen label has no adverse-reaction text	serious PRR 1.3	no trial arm names this drug

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: Lithium ↔ Nephrogenic diabetes insipidus.

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 Lithium Bromatum?

In FDA FAERS, the most frequently co-reported reaction terms for Lithium Bromatum are toxicity to various agents, tremor, nausea, weight increased, fatigue, vomiting. 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 Lithium Bromatum have an FDA boxed warning?

No. The FDA label retrieved for Lithium Bromatum has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Lithium Bromatum 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 f4a1d451-33ad-4df3-ae68-58cfbfccfa89, effective 20260112; matched on openfda.generic_name.exact:"LITHIUM BROMATUM")
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, field patient.drug.openfda.generic_name.exact, 1,221 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
ClinicalTrials.gov API v2 (query LITHIUM BROMATUM, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.