Drug · FAERS side-effect profile with label screen
Dronabinol side effects: what 7,992 FDA adverse event reports show
Drug class
Cannabinoid
FDA label (Established Pharmacologic Class)
Who reports
7,992 reports · 75% serious · 1,672 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Dronabinol oral solution is indicated in adults for the treatment of: anorexia associated with weight loss in patients with Acquired Immune Deficiency Syndrome (AIDS). nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments.
FDA label, Indications and Usage
What it is
Dronabinol is a cannabinoid designated chemically as (6aR,10aR)-6a,7,8,10a-Tetrahydro-6,6,9-trimethyl-3-pentyl-6H-dibenzo[b,d]-pyran-1-ol. Dronabinol has the following empirical and structural formulas: C 21 H 30 O 2 (molecular weight=314.46) Dronabinol is a clear colorless to amber oil.
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 1Labeled (related wording) 2Reporting / coding artifact 5Lab value / disease marker 2Outcome field, not a reaction 1Not in label — unassessed 29
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.
- Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
- 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. 1,030 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 |
|---|---|---|---|---|---|---|
| Nail bed inflammation | 29 | 263.3 179.8–385.5ROR 264.2 · χ² 6,642 / p <1e-300 | 206.7 EB05 150.9 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 48%) | no trial data cached |
| Child neglect | 12 | 156.0 87.2–279.3ROR 156.3 · χ² 1,600 / p <1e-300 | 119.7 EB05 73.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Nasal mucosal disorder | 29 | 136.9 94.3–198.8ROR 137.4 · χ² 3,589 / p <1e-300 | 120.0 EB05 87.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=29 · ♀ 100% (drug 48%) | no trial data cached |
| Streptococcal sepsis | 34 | 76.9 54.7–108.1ROR 77.2 · χ² 2,401 / p <1e-300 | 71.8 EB05 53.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 48%) | no trial data cached |
| Drug screen positive | 209 | 71.4 62.4–81.8ROR 73.3 · χ² 14,064 / p <1e-300 | 69.1 EB05 61.6 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=190 | no trial data cached |
| Muscle mass | 10 | 60.7 32.5–113.7ROR 60.8 · χ² 517 / p 9e-115 | 53.7 EB05 31.1 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Homicide | 39 | 57.9 42.2–79.5ROR 58.2 · χ² 2,078 / p <1e-300 | 55.2 EB05 42.1 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 26% (drug 48%) · 90% consumer | no trial data cached |
| Pseudomonal sepsis | 36 | 54.7 39.3–76.0ROR 54.9 · χ² 1,806 / p <1e-300 | 52.2 EB05 39.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 48%) | no trial data cached |
| Vascular device infection | 64 | 37.7 29.5–48.2ROR 38.0 · χ² 2,218 / p <1e-300 | 36.8 EB05 29.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 100% (drug 48%) | no trial data cached |
| Myocardial fibrosis | 11 | 34.8 19.2–63.0ROR 34.8 · χ² 323 / p 1e-72 | 32.5 EB05 19.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Failure to thrive | 61 | 31.1 24.1–39.9ROR 31.3 · χ² 1,724 / p <1e-300 | 30.4 EB05 24.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=61 · 91% clinician | no trial data cached |
| Testicular atrophy | 10 | 30.5 16.3–56.8ROR 30.5 · χ² 253 / p 2e-57 | 28.6 EB05 16.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Bone demineralisation | 11 | 27.4 15.2–49.7ROR 27.5 · χ² 252 / p 5e-57 | 26.0 EB05 15.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Drug diversion | 59 | 27.3 21.1–35.3ROR 27.5 · χ² 1,454 / p <1e-300 | 26.8 EB05 21.6 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=29 · 88% consumer | no trial data cached |
| Product temperature excursion issue | 46 | 25.7 19.2–34.3ROR 25.8 · χ² 1,055 / p 9e-232 | 25.2 EB05 19.6 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | ♀ 72% (drug 48%) · 100% clinician | no trial data cached |
| B-lymphocyte count decreased | 12 | 23.6 13.4–41.6ROR 23.6 · χ² 235 / p 2e-53 | 22.5 EB05 13.4 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Impaired driving ability | 94 | 21.8 17.8–26.7ROR 22.1 · χ² 1,834 / p <1e-300 | 21.6 EB05 18.2 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 21.5 · 95% consumer | no trial data cached |
| Cardiac death | 10 | 21.6 11.6–40.3ROR 21.6 · χ² 175 / p 3e-40 | 20.3 EB05 11.0 · IC025 +2.4 3/3 methods agree | Outcome field, not a reaction | serious n=10 | no trial data cached |
| Arteriosclerosis coronary artery | 52 | 20.8 15.8–27.3ROR 20.9 · χ² 953 / p 1e-209 | 20.5 EB05 16.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=52 · ♀ 0% (drug 48%) · 90% clinician | no trial data cached |
| Immune reconstitution syndrome | 10 | 20.2 10.8–37.6ROR 20.2 · χ² 163 / p 2e-37 | 18.8 EB05 10.0 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Poisoning | 95 | 19.9 16.3–24.3ROR 20.1 · χ² 1,674 / p <1e-300 | 19.7 EB05 16.6 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.5 · ♀ 11% (drug 48%) · 93% clinician | no trial data cached |
| Brain oedema | 93 | 19.5 15.9–23.8ROR 19.7 · χ² 1,599 / p <1e-300 | 19.2 EB05 16.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 15.0 | no trial data cached |
| Soft tissue infection | 13 | 18.9 11.0–32.7ROR 19.0 · χ² 202 / p 4e-46 | 18.0 EB05 10.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Paronychia | 31 | 18.9 13.3–26.9ROR 19.0 · χ² 505 / p 4e-112 | 18.6 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 86% (drug 48%) · 100% clinician | no trial data cached |
| Substance abuse | 58 | 18.8 14.5–24.3ROR 18.9 · χ² 952 / p 2e-209 | 18.5 EB05 14.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.8 · ♀ 16% (drug 48%) | no trial data cached |
| Infective pulmonary exacerbation of cystic fibrosis | 39 | 18.8 13.7–25.7ROR 18.9 · χ² 634 / p 3e-140 | 18.5 EB05 14.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=35 | no trial data cached |
| Hangover | 25 | 18.7 12.6–27.6ROR 18.7 · χ² 398 / p 1e-88 | 18.2 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 48%) | no trial data cached |
| Asphyxia | 52 | 16.8 12.8–22.0ROR 16.9 · χ² 752 / p 9e-166 | 16.6 EB05 13.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 · ♀ 25% (drug 48%) · 96% clinician | no trial data cached |
| Pancreatic carcinoma metastatic | 18 | 16.6 10.5–26.4ROR 16.7 · χ² 247 / p 5e-56 | 16.0 EB05 10.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Varicose vein | 32 | 16.3 11.5–23.0ROR 16.3 · χ² 441 / p 4e-98 | 15.9 EB05 11.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 100% (drug 48%) | no trial data cached |
| Metastases to lymph nodes | 36 | 14.2 10.2–19.6ROR 14.2 · χ² 425 / p 1e-94 | 13.8 EB05 10.2 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=36 · ♀ 100% (drug 48%) | no trial data cached |
| Lobar pneumonia | 10 | 14.0 7.5–26.1ROR 14.1 · χ² 108 / p 1e-25 | 12.1 EB05 6.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Drug level above therapeutic | 24 | 13.9 9.3–20.8ROR 14.0 · χ² 273 / p 1e-61 | 13.3 EB05 9.1 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=24 · ♀ 0% (drug 48%) · 100% clinician | no trial data cached |
| Physical assault | 11 | 13.9 7.7–25.1ROR 13.9 · χ² 118 / p 8e-28 | 12.2 EB05 6.3 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Neurogenic bladder | 11 | 13.7 7.6–24.7ROR 13.7 · χ² 116 / p 2e-27 | 12.0 EB05 6.2 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Autonomic nervous system imbalance | 14 | 12.8 7.6–21.7ROR 12.8 · χ² 140 / p 1e-32 | 11.5 EB05 6.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Malnutrition | 52 | 12.3 9.4–16.2ROR 12.4 · χ² 528 / p 4e-117 | 12.0 EB05 9.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 | no trial data cached |
| Thoracic vertebral fracture | 13 | 11.6 6.7–20.0ROR 11.6 · χ² 115 / p 3e-27 | 10.0 EB05 5.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Economic problem | 63 | 10.8 8.4–13.8ROR 10.8 · χ² 546 / p 4e-121 | 10.4 EB05 8.4 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 8.7 · ♀ 22% (drug 48%) · 100% consumer | no trial data cached |
| Paradoxical drug reaction | 15 | 10.8 6.5–17.8ROR 10.8 · χ² 123 / p 8e-29 | 9.3 EB05 5.6 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | 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 |
|---|---|---|---|---|---|---|
| Nausea | 894 | 3.0 2.8–3.2ROR 3.2 · χ² 1,214 / p 2e-266 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.2 | no trial data cached |
| Fatigue (tiredness) | 709 | 2.4 2.2–2.6ROR 2.5 · χ² 596 / p 5e-132 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Diarrhoea (diarrhea) | 615 | 2.5 2.3–2.7ROR 2.6 · χ² 574 / p 4e-127 | 2.5 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Death | 600 | 1.8 1.7–2.0ROR 1.9 · χ² 234 / p 5e-53 | 1.8 EB05 1.7 · IC025 +0.7 | Outcome field, not a reaction | serious PRR 1.4 | no trial data cached |
| Vomiting | 591 | 3.3 3.1–3.6ROR 3.5 · χ² 971 / p 2e-213 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.1 | no trial data cached |
| Off label use (used outside approved label) | 506 | 1.5 1.4–1.7ROR 1.6 · χ² 96 / p 5e-23 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.3 | no trial data cached |
| Decreased appetite (loss of appetite) | 452 | 5.1 4.7–5.6ROR 5.4 · χ² 1,511 / p <1e-300 | 5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Pain | 435 | 1.9 1.7–2.0ROR 1.9 · χ² 176 / p 2e-40 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Weight decreased (weight loss) | 417 | 3.9 3.6–4.3ROR 4.1 · χ² 917 / p 1e-201 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.6 | no trial data cached |
| Dyspnoea (shortness of breath) | 383 | 1.8 1.6–2.0ROR 1.8 · χ² 133 / p 5e-31 | 1.8 EB05 1.6 · IC025 +0.7 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Asthenia (weakness) | 380 | 2.7 2.4–2.9ROR 2.7 · χ² 396 / p 2e-88 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | no trial data cached |
| Toxicity to various agents | 338 | 5.3 4.8–5.9ROR 5.5 · χ² 1,179 / p 1e-258 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 · ♀ 20% (drug 48%) | no trial data cached |
| Drug ineffective (drug did not work) | 327 | 0.7 0.6–0.7ROR 0.6 · χ² 65 / p 4e-16 | 0.7 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Headache | 316 | 1.3 1.2–1.5ROR 1.3 · χ² 25 / p 2e-7 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.6 | no trial data cached |
| Pneumonia (lung infection) | 307 | 2.5 2.2–2.8ROR 2.6 · χ² 277 / p 2e-62 | 2.5 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.0 | 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.
- Nail bed inflammation — n=29, PRR 263.3
- Nasal mucosal disorder — n=29, PRR 136.9
- Streptococcal sepsis — n=34, PRR 76.9
- Homicide — n=39, PRR 57.9
- Pseudomonal sepsis — n=36, PRR 54.7
- Vascular device infection — n=64, PRR 37.7
- Failure to thrive — n=61, PRR 31.1
- Arteriosclerosis coronary artery — n=52, PRR 20.8
- Brain oedema — n=93, PRR 19.5
- Paronychia — n=31, PRR 18.9
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 Dronabinol?
In FDA FAERS, the most frequently co-reported reaction terms for Dronabinol are nausea, fatigue, diarrhoea, vomiting, decreased appetite, pain. 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 Dronabinol have an FDA boxed warning?
No. The FDA label retrieved for Dronabinol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Dronabinol 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 495aabae-3597-49dc-a5af-e328bcd937b7, effective 20260211; matched on
openfda.generic_name.exact:"DRONABINOL") - 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, 1,070 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.