Nabilone side effects: what 1,716 FDA adverse event reports show

Nabilone · 198 reaction terms · 7,150 drug–reaction co-reports · data 2026-09-14

Drug class

No validated FDA label found

Who reports

1,716 reports · 99% serious · 94 with death outcome · 64% 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 3Lab value / disease marker 8No label text to screen 29

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. 158 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
Fibromyalgia	97	41.9 34.5–50.9ROR 43.9 · χ² 3,818 / p <1e-300	41.4 EB05 34.9 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Body temperature decreased	39	41.2 30.2–56.2ROR 42.0 · χ² 1,484 / p <1e-300	40.3 EB05 30.7 · IC025 +4.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Ankylosing spondylitis	43	34.6 25.7–46.5ROR 35.3 · χ² 1,365 / p 5e-299	34.0 EB05 26.3 · IC025 +4.1 3/3 methods agree	No label text to screen	–	no trial data cached
Musculoskeletal stiffness	286	34.2 30.7–38.1ROR 39.7 · χ² 9,186 / p <1e-300	34.0 EB05 30.8 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Pelvic pain	58	33.4 25.9–43.1ROR 34.4 · χ² 1,786 / p <1e-300	33.0 EB05 26.4 · IC025 +4.3 3/3 methods agree	No label text to screen	–	no trial data cached
Mood altered	80	30.8 24.9–38.2ROR 32.1 · χ² 2,275 / p <1e-300	30.5 EB05 25.3 · IC025 +4.3 3/3 methods agree	No label text to screen	–	no trial data cached
Blood pressure systolic increased	56	29.9 23.1–38.8ROR 30.8 · χ² 1,534 / p <1e-300	29.6 EB05 23.6 · IC025 +4.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Kidney infection	56	29.9 23.1–38.7ROR 30.7 · χ² 1,532 / p <1e-300	29.5 EB05 23.6 · IC025 +4.1 3/3 methods agree	No label text to screen	–	no trial data cached
Contraindicated product administered	84	29.2 23.6–36.0ROR 30.4 · χ² 2,253 / p <1e-300	28.9 EB05 24.1 · IC025 +4.3 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Orthostatic hypotension (dizziness on standing)	45	27.0 20.2–36.1ROR 27.6 · χ² 1,099 / p 3e-241	26.7 EB05 20.7 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Poor venous access	25	25.3 17.2–37.4ROR 25.7 · χ² 560 / p 5e-124	24.9 EB05 17.7 · IC025 +3.4 3/3 methods agree	No label text to screen	–	no trial data cached
Dystonia	46	24.7 18.6–32.9ROR 25.3 · χ² 1,023 / p 1e-224	24.5 EB05 19.1 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Rheumatoid arthritis	265	24.5 21.9–27.4ROR 28.1 · χ² 5,976 / p <1e-300	24.4 EB05 22.1 · IC025 +4.3 3/3 methods agree	No label text to screen	–	no trial data cached
Oral herpes	45	24.2 18.1–32.3ROR 24.8 · χ² 977 / p 8e-215	24.0 EB05 18.6 · IC025 +3.8 3/3 methods agree	No label text to screen	–	no trial data cached
Cognitive disorder	93	20.9 17.1–25.5ROR 21.9 · χ² 1,744 / p <1e-300	20.8 EB05 17.5 · IC025 +3.9 3/3 methods agree	No label text to screen	–	no trial data cached
Therapeutic response shortened	63	20.7 16.2–26.4ROR 21.3 · χ² 1,162 / p 7e-255	20.6 EB05 16.6 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Injection site warmth	39	19.8 14.5–27.0ROR 20.2 · χ² 677 / p 1e-149	19.6 EB05 14.9 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Psychotic disorder	55	19.5 15.0–25.3ROR 20.0 · χ² 945 / p 7e-208	19.3 EB05 15.4 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Therapeutic product effect incomplete	126	18.6 15.7–22.1ROR 19.8 · χ² 2,089 / p <1e-300	18.6 EB05 16.0 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Red blood cell sedimentation rate increased	19	17.9 11.4–28.0ROR 18.1 · χ² 286 / p 1e-64	17.4 EB05 11.5 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Hypotonia	17	17.7 11.0–28.5ROR 17.9 · χ² 252 / p 6e-57	17.2 EB05 11.0 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
Platelet count increased	21	16.8 11.0–25.7ROR 17.0 · χ² 296 / p 1e-66	16.4 EB05 11.0 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Musculoskeletal pain	84	16.6 13.5–20.5ROR 17.3 · χ² 1,220 / p 2e-267	16.5 EB05 13.8 · IC025 +3.6 3/3 methods agree	No label text to screen	–	no trial data cached
Blood pressure fluctuation	37	16.1 11.7–22.1ROR 16.4 · χ² 508 / p 9e-113	15.9 EB05 11.9 · IC025 +3.2 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Blood iron decreased	18	16.0 10.1–25.3ROR 16.1 · χ² 238 / p 7e-54	15.4 EB05 9.8 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Thyroid cancer	18	15.5 9.8–24.6ROR 15.7 · χ² 230 / p 3e-52	14.9 EB05 9.5 · IC025 +2.7 3/3 methods agree	No label text to screen	–	no trial data cached
Sputum discoloured	14	15.5 9.2–26.1ROR 15.6 · χ² 175 / p 3e-40	14.5 EB05 8.5 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Back injury	15	14.5 8.7–24.0ROR 14.6 · χ² 175 / p 3e-40	13.5 EB05 8.0 · IC025 +2.5 3/3 methods agree	No label text to screen	–	no trial data cached
Neck pain	76	14.2 11.4–17.7ROR 14.7 · χ² 921 / p 2e-202	14.1 EB05 11.6 · IC025 +3.3 3/3 methods agree	No label text to screen	–	no trial data cached
Tenderness	14	14.0 8.3–23.6ROR 14.1 · χ² 156 / p 4e-36	12.9 EB05 7.4 · IC025 +2.4 3/3 methods agree	No label text to screen	–	no trial data cached
Injection site mass	49	13.9 10.5–18.3ROR 14.2 · χ² 574 / p 4e-127	13.7 EB05 10.7 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Osteomyelitis	24	13.9 9.3–20.6ROR 14.0 · χ² 274 / p 9e-62	13.3 EB05 9.1 · IC025 +2.8 3/3 methods agree	No label text to screen	–	no trial data cached
C-reactive protein increased	48	13.8 10.4–18.3ROR 14.1 · χ² 557 / p 2e-123	13.6 EB05 10.5 · IC025 +3.1 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Drug hypersensitivity	256	13.8 12.3–15.5ROR 15.6 · χ² 3,046 / p <1e-300	13.7 EB05 12.4 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Nerve compression	12	13.6 7.7–23.9ROR 13.7 · χ² 128 / p 6e-30	12.1 EB05 6.6 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Gait disturbance	246	13.4 11.9–15.1ROR 15.1 · χ² 2,833 / p <1e-300	13.4 EB05 12.0 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Incontinence	13	12.8 7.5–22.1ROR 12.9 · χ² 130 / p 2e-30	11.4 EB05 6.4 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Paranoia	21	12.7 8.3–19.4ROR 12.8 · χ² 214 / p 8e-49	11.9 EB05 7.8 · IC025 +2.6 3/3 methods agree	No label text to screen	–	no trial data cached
Haematocrit decreased	24	12.6 8.4–18.7ROR 12.7 · χ² 244 / p 3e-55	11.9 EB05 8.1 · IC025 +2.7 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Obstructive airways disorder	13	12.2 7.1–20.9ROR 12.2 · χ² 122 / p 1e-28	10.7 EB05 6.0 · IC025 +2.2 3/3 methods agree	No label text to screen	–	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	477	8.1 7.5–8.8ROR 10.3 · χ² 3,049 / p <1e-300	8.1 EB05 7.5 · IC025 +2.9 3/3 methods agree	No label text to screen	–	no trial data cached
Musculoskeletal stiffness	286	34.2 30.7–38.1ROR 39.7 · χ² 9,186 / p <1e-300	34.0 EB05 30.8 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Insomnia (trouble sleeping)	265	10.4 9.3–11.6ROR 11.8 · χ² 2,264 / p <1e-300	10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Rheumatoid arthritis	265	24.5 21.9–27.4ROR 28.1 · χ² 5,976 / p <1e-300	24.4 EB05 22.1 · IC025 +4.3 3/3 methods agree	No label text to screen	–	no trial data cached
Drug hypersensitivity	256	13.8 12.3–15.5ROR 15.6 · χ² 3,046 / p <1e-300	13.7 EB05 12.4 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Gait disturbance	246	13.4 11.9–15.1ROR 15.1 · χ² 2,833 / p <1e-300	13.4 EB05 12.0 · IC025 +3.5 3/3 methods agree	No label text to screen	–	no trial data cached
Arthralgia (joint pain)	224	5.6 5.0–6.4ROR 6.2 · χ² 869 / p 3e-191	5.6 EB05 5.0 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Back pain	140	6.3 5.4–7.4ROR 6.7 · χ² 624 / p 4e-138	6.2 EB05 5.4 · IC025 +2.3 3/3 methods agree	No label text to screen	–	no trial data cached
Therapeutic product effect incomplete	126	18.6 15.7–22.1ROR 19.8 · χ² 2,089 / p <1e-300	18.6 EB05 16.0 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	–	no trial data cached
Joint swelling	125	10.8 9.2–12.9ROR 11.5 · χ² 1,113 / p 3e-244	10.7 EB05 9.2 · IC025 +3.1 3/3 methods agree	No label text to screen	–	no trial data cached
Blood pressure increased	115	7.8 6.6–9.4ROR 8.3 · χ² 684 / p 4e-151	7.7 EB05 6.5 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	–	no trial data cached
Nasopharyngitis (common cold)	101	5.7 4.7–6.9ROR 6.0 · χ² 391 / p 2e-87	5.6 EB05 4.7 · IC025 +2.2 3/3 methods agree	No label text to screen	–	no trial data cached
Muscle spasms	100	5.7 4.7–6.9ROR 5.9 · χ² 385 / p 5e-86	5.6 EB05 4.7 · IC025 +2.1 3/3 methods agree	No label text to screen	–	no trial data cached
Fibromyalgia	97	41.9 34.5–50.9ROR 43.9 · χ² 3,818 / p <1e-300	41.4 EB05 34.9 · IC025 +4.8 3/3 methods agree	No label text to screen	–	no trial data cached
Cognitive disorder	93	20.9 17.1–25.5ROR 21.9 · χ² 1,744 / p <1e-300	20.8 EB05 17.5 · IC025 +3.9 3/3 methods agree	No label text to screen	–	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 Nabilone?

In FDA FAERS, the most frequently co-reported reaction terms for Nabilone are pain, musculoskeletal stiffness, insomnia, rheumatoid arthritis, drug hypersensitivity, gait disturbance. 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 Nabilone 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 Nabilone 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, 198 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.