Famotitine side effects: what 2,940 FDA adverse event reports show

Famotitine · 99 reaction terms · 8,742 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

2,940 reports · 91% serious · 273 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

—

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 1Lab value / disease marker 1No label text to screen 38

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. 59 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
End stage renal disease	576	230.3 213.7–248.1ROR 286.2 · χ² 127,219 / p <1e-300	221.4 EB05 206.6 · IC025 +7.4 3/3 methods agree	No label text to screen	serious PRR 140.4 · 74% consumer	no trial data cached
Chronic kidney disease	1,896	180.9 176.0–186.0ROR 507.7 · χ² 331,789 / p <1e-300	176.1 EB05 169.6 · IC025 +7.3 3/3 methods agree	No label text to screen	serious PRR 112.9	no trial data cached
Renal injury	430	103.6 94.9–113.2ROR 121.2 · χ² 43,038 / p <1e-300	101.7 EB05 93.9 · IC025 +6.4 3/3 methods agree	No label text to screen	serious PRR 64.5	no trial data cached
Multiple fractures	161	70.0 60.2–81.4ROR 74.0 · χ² 10,777 / p <1e-300	68.7 EB05 60.3 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 40.7	no trial data cached
Tubulointerstitial nephritis	175	67.3 58.2–77.7ROR 71.5 · χ² 11,259 / p <1e-300	66.2 EB05 58.3 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 42.1	no trial data cached
Vitamin d deficiency	87	64.2 52.2–79.1ROR 66.2 · χ² 5,306 / p <1e-300	62.8 EB05 52.5 · IC025 +5.2 3/3 methods agree	No label text to screen	serious PRR 45.1 · ♀ 82% (drug 58%)	no trial data cached
Renal failure (kidney failure)	1,018	54.7 52.0–57.5ROR 83.1 · χ² 53,531 / p <1e-300	54.2 EB05 51.5 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 34.4	no trial data cached
Bone disorder	137	53.6 45.5–63.1ROR 56.1 · χ² 6,968 / p <1e-300	52.8 EB05 45.8 · IC025 +5.2 3/3 methods agree	No label text to screen	serious PRR 39.0	no trial data cached
Acute kidney injury (sudden kidney damage)	1,087	51.3 48.9–53.8ROR 80.8 · χ² 53,525 / p <1e-300	50.9 EB05 48.4 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 32.1	no trial data cached
Osteoporosis	283	49.3 44.2–55.1ROR 54.5 · χ² 13,290 / p <1e-300	48.9 EB05 44.3 · IC025 +5.3 3/3 methods agree	No label text to screen	serious PRR 32.8	no trial data cached
Nephropathy	56	42.8 33.0–55.5ROR 43.6 · χ² 2,232 / p <1e-300	42.0 EB05 33.5 · IC025 +4.5 3/3 methods agree	No label text to screen	serious PRR 28.6	no trial data cached
Intervertebral disc degeneration	50	38.5 29.2–50.7ROR 39.2 · χ² 1,781 / p <1e-300	37.8 EB05 29.8 · IC025 +4.3 3/3 methods agree	No label text to screen	serious PRR 27.1	no trial data cached
Renal tubular necrosis	52	37.9 28.9–49.7ROR 38.6 · χ² 1,823 / p <1e-300	37.2 EB05 29.5 · IC025 +4.3 3/3 methods agree	No label text to screen	serious PRR 23.9	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	382	34.1 31.1–37.5ROR 39.1 · χ² 12,242 / p <1e-300	33.9 EB05 31.2 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 32.8 · 73% consumer	no trial data cached
Osteopenia	67	31.5 24.8–39.9ROR 32.2 · χ² 1,938 / p <1e-300	31.1 EB05 25.3 · IC025 +4.3 3/3 methods agree	No label text to screen	serious PRR 21.2 · ♀ 81% (drug 58%)	no trial data cached
Foot fracture	70	26.3 20.9–33.2ROR 27.0 · χ² 1,677 / p <1e-300	26.1 EB05 21.4 · IC025 +4.1 3/3 methods agree	No label text to screen	serious PRR 18.6 · ♀ 84% (drug 58%)	no trial data cached
Ankle fracture	52	24.0 18.3–31.4ROR 24.4 · χ² 1,120 / p 6e-246	23.7 EB05 18.8 · IC025 +3.8 3/3 methods agree	No label text to screen	serious PRR 16.1 · ♀ 83% (drug 58%)	no trial data cached
Wrist fracture	34	20.3 14.5–28.3ROR 20.5 · χ² 603 / p 2e-133	20.0 EB05 14.9 · IC025 +3.4 3/3 methods agree	No label text to screen	serious PRR 15.0 · ♀ 91% (drug 58%)	no trial data cached
Arthritis	174	15.8 13.7–18.2ROR 16.7 · χ² 2,398 / p <1e-300	15.7 EB05 13.8 · IC025 +3.7 3/3 methods agree	No label text to screen	serious PRR 14.6	no trial data cached
Osteoarthritis	82	13.8 11.1–17.1ROR 14.2 · χ² 960 / p 4e-211	13.7 EB05 11.3 · IC025 +3.3 3/3 methods agree	No label text to screen	serious PRR 9.4	no trial data cached
Bipolar disorder	21	13.7 8.9–21.0ROR 13.8 · χ² 234 / p 3e-53	13.0 EB05 8.6 · IC025 +2.7 3/3 methods agree	No label text to screen	serious PRR 9.9 · ♀ 100% (drug 58%)	no trial data cached
Back disorder	31	13.6 9.6–19.3ROR 13.7 · χ² 348 / p 6e-78	13.2 EB05 9.5 · IC025 +2.9 3/3 methods agree	No label text to screen	serious PRR 11.9	no trial data cached
Carpal tunnel syndrome	25	12.7 8.6–18.8ROR 12.8 · χ² 258 / p 2e-58	12.1 EB05 8.3 · IC025 +2.7 3/3 methods agree	No label text to screen	serious PRR 9.9 · ♀ 92% (drug 58%)	no trial data cached
Intervertebral disc protrusion	39	12.7 9.3–17.4ROR 12.9 · χ² 409 / p 3e-91	12.4 EB05 9.2 · IC025 +2.9 3/3 methods agree	No label text to screen	serious PRR 8.9	no trial data cached
Back injury	19	12.5 8.0–19.6ROR 12.6 · χ² 190 / p 2e-43	11.6 EB05 7.4 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 10.4	no trial data cached
Lower limb fracture	33	12.3 8.8–17.3ROR 12.5 · χ² 333 / p 1e-74	11.9 EB05 8.6 · IC025 +2.8 3/3 methods agree	No label text to screen	serious PRR 7.8 · ♀ 88% (drug 58%)	no trial data cached
Spinal disorder	16	12.0 7.4–19.6ROR 12.1 · χ² 151 / p 5e-35	10.9 EB05 6.5 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 8.8	no trial data cached
Upper limb fracture	33	11.8 8.4–16.5ROR 11.9 · χ² 315 / p 1e-70	11.3 EB05 8.2 · IC025 +2.8 3/3 methods agree	No label text to screen	serious PRR 8.5	no trial data cached
Ligament sprain	16	11.6 7.1–18.9ROR 11.6 · χ² 144 / p 2e-33	10.4 EB05 6.3 · IC025 +2.3 3/3 methods agree	No label text to screen	serious n=14	no trial data cached
Gallbladder disorder	27	10.8 7.4–15.7ROR 10.9 · χ² 229 / p 4e-52	10.1 EB05 7.0 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 7.2 · ♀ 89% (drug 58%)	no trial data cached
Bone density decreased	47	10.6 8.0–14.1ROR 10.8 · χ² 399 / p 5e-89	10.2 EB05 7.8 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 8.0	no trial data cached
Rib fracture	30	10.4 7.3–14.9ROR 10.5 · χ² 247 / p 7e-56	9.8 EB05 7.0 · IC025 +2.6 3/3 methods agree	No label text to screen	serious PRR 7.2	no trial data cached
Product odour abnormal	14	9.6 5.7–16.2ROR 9.7 · χ² 100 / p 9e-24	8.1 EB05 4.9 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious n=10	no trial data cached
Joint dislocation	14	9.5 5.6–16.0ROR 9.5 · χ² 98 / p 2e-23	8.0 EB05 4.8 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 6.7	no trial data cached
Glaucoma	24	8.9 6.0–13.2ROR 9.0 · χ² 160 / p 5e-37	8.0 EB05 5.5 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 5.8 · ♀ 78% (drug 58%)	no trial data cached
Dyspepsia (indigestion)	117	8.5 7.1–10.2ROR 8.8 · χ² 771 / p 5e-170	8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree	No label text to screen	serious PRR 7.3 · 83% consumer	no trial data cached
Spinal fracture	22	7.9 5.2–11.9ROR 7.9 · χ² 125 / p 2e-29	7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 5.2	no trial data cached
Joint injury	23	7.7 5.1–11.5ROR 7.7 · χ² 127 / p 9e-30	6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree	No label text to screen	serious PRR 5.7	no trial data cached
Angina pectoris	30	7.4 5.2–10.6ROR 7.5 · χ² 160 / p 5e-37	6.8 EB05 4.9 · IC025 +2.1 3/3 methods agree	No label text to screen	serious PRR 4.7	no trial data cached
Chronic obstructive pulmonary disease	51	7.0 5.3–9.2ROR 7.1 · χ² 256 / p 7e-58	6.6 EB05 5.2 · IC025 +2.3 3/3 methods agree	No label text to screen	serious PRR 5.0	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	1,896	180.9 176.0–186.0ROR 507.7 · χ² 331,789 / p <1e-300	176.1 EB05 169.6 · IC025 +7.3 3/3 methods agree	No label text to screen	serious PRR 112.9	no trial data cached
Acute kidney injury (sudden kidney damage)	1,087	51.3 48.9–53.8ROR 80.8 · χ² 53,525 / p <1e-300	50.9 EB05 48.4 · IC025 +5.5 3/3 methods agree	No label text to screen	serious PRR 32.1	no trial data cached
Renal failure (kidney failure)	1,018	54.7 52.0–57.5ROR 83.1 · χ² 53,531 / p <1e-300	54.2 EB05 51.5 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 34.4	no trial data cached
End stage renal disease	576	230.3 213.7–248.1ROR 286.2 · χ² 127,219 / p <1e-300	221.4 EB05 206.6 · IC025 +7.4 3/3 methods agree	No label text to screen	serious PRR 140.4 · 74% consumer	no trial data cached
Renal injury	430	103.6 94.9–113.2ROR 121.2 · χ² 43,038 / p <1e-300	101.7 EB05 93.9 · IC025 +6.4 3/3 methods agree	No label text to screen	serious PRR 64.5	no trial data cached
Gastrooesophageal reflux disease (acid reflux)	382	34.1 31.1–37.5ROR 39.1 · χ² 12,242 / p <1e-300	33.9 EB05 31.2 · IC025 +4.9 3/3 methods agree	No label text to screen	serious PRR 32.8 · 73% consumer	no trial data cached
Osteoporosis	283	49.3 44.2–55.1ROR 54.5 · χ² 13,290 / p <1e-300	48.9 EB05 44.3 · IC025 +5.3 3/3 methods agree	No label text to screen	serious PRR 32.8	no trial data cached
Depression	218	6.8 6.0–7.7ROR 7.3 · χ² 1,085 / p 2e-238	6.7 EB05 6.0 · IC025 +2.5 3/3 methods agree	No label text to screen	serious PRR 5.7	no trial data cached
Tubulointerstitial nephritis	175	67.3 58.2–77.7ROR 71.5 · χ² 11,259 / p <1e-300	66.2 EB05 58.3 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 42.1	no trial data cached
Arthritis	174	15.8 13.7–18.2ROR 16.7 · χ² 2,398 / p <1e-300	15.7 EB05 13.8 · IC025 +3.7 3/3 methods agree	No label text to screen	serious PRR 14.6	no trial data cached
Multiple fractures	161	70.0 60.2–81.4ROR 74.0 · χ² 10,777 / p <1e-300	68.7 EB05 60.3 · IC025 +5.6 3/3 methods agree	No label text to screen	serious PRR 40.7	no trial data cached
Bone disorder	137	53.6 45.5–63.1ROR 56.1 · χ² 6,968 / p <1e-300	52.8 EB05 45.8 · IC025 +5.2 3/3 methods agree	No label text to screen	serious PRR 39.0	no trial data cached
Dyspepsia (indigestion)	117	8.5 7.1–10.2ROR 8.8 · χ² 771 / p 5e-170	8.3 EB05 7.1 · IC025 +2.7 3/3 methods agree	No label text to screen	serious PRR 7.3 · 83% consumer	no trial data cached
Vitamin d deficiency	87	64.2 52.2–79.1ROR 66.2 · χ² 5,306 / p <1e-300	62.8 EB05 52.5 · IC025 +5.2 3/3 methods agree	No label text to screen	serious PRR 45.1 · ♀ 82% (drug 58%)	no trial data cached
Osteoarthritis	82	13.8 11.1–17.1ROR 14.2 · χ² 960 / p 4e-211	13.7 EB05 11.3 · IC025 +3.3 3/3 methods agree	No label text to screen	serious PRR 9.4	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 Famotitine?

In FDA FAERS, the most frequently co-reported reaction terms for Famotitine are chronic kidney disease, acute kidney injury, renal failure, end stage renal disease, renal injury, 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 Famotitine have an FDA boxed warning?

No validated FDA label could be retrieved for this product name, so this page cannot say.

Do FAERS signals prove that Famotitine 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

No FDA label passed the name-validation check for this product string, so label-based screening was skipped
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, 99 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.