Drug · FAERS side-effect profile with label screen
Aprepitant side effects: what 18,353 FDA adverse event reports show
Drug class
Substance P/Neurokinin-1 Receptor Antagonist
FDA label (Established Pharmacologic Class)
Brand names
Cinvanti
openFDA label
Who reports
18,353 reports · 89% serious · 3,080 with death outcome · 63% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CINVANTI, in combination with other antiemetic agents, is indicated in adults for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen.
FDA label, Indications and Usage
What it is
CINVANTI injectable emulsion contains the active ingredient, aprepitant. Aprepitant is a substance P/neurokinin 1 (NK 1 ) receptor antagonist, an antiemetic agent, chemically described as 5-[[.
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 (related wording) 2Lab value / disease marker 9Not in label — unassessed 29
What the badges mean
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- 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. 1,062 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 |
|---|---|---|---|---|---|---|
| Computerised tomogram thorax | 39 | 2,091.9 1,230.9–3,555.1ROR 2,096.4 · χ² 27,800 / p <1e-300 | 538.2 EB05 410.8 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Grip strength | 121 | 1,262.0 974.0–1,635.2ROR 1,270.4 · χ² 71,310 / p <1e-300 | 544.2 EB05 467.5 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=121 · ♀ 100% (drug 63%) · 97% clinician | not reported in cached trials |
| Testicular germ cell cancer metastatic | 13 | 1,046.0 491.7–2,224.9ROR 1,046.7 · χ² 6,505 / p <1e-300 | 301.8 EB05 187.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Swollen joint count | 93 | 698.4 539.4–904.2ROR 701.9 · χ² 39,548 / p <1e-300 | 396.2 EB05 333.1 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=93 · ♀ 100% (drug 63%) · 97% clinician | not reported in cached trials |
| Lupus vulgaris | 267 | 331.2 289.2–379.4ROR 336.1 · χ² 67,678 / p <1e-300 | 251.6 EB05 227.3 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=267 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 126 | 266.3 219.4–323.2ROR 268.1 · χ² 26,720 / p <1e-300 | 208.8 EB05 179.9 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=126 · ♀ 100% (drug 63%) · 98% clinician | not reported in cached trials |
| Infusion site streaking | 15 | 238.0 136.4–415.3ROR 238.2 · χ² 2,730 / p <1e-300 | 157.6 EB05 101.4 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | not reported in cached trials |
| Procalcitonin decreased | 12 | 237.1 127.3–441.9ROR 237.3 · χ² 2,140 / p <1e-300 | 149.9 EB05 91.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| C-reactive protein | 147 | 221.1 185.4–263.7ROR 222.9 · χ² 26,738 / p <1e-300 | 180.7 EB05 157.4 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=147 · ♀ 100% (drug 63%) · 98% clinician | not reported in cached trials |
| Acquired porphyria | 11 | 210.0 110.3–399.7ROR 210.1 · χ² 1,756 / p <1e-300 | 136.0 EB05 81.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Porphyria acute | 212 | 207.5 179.3–240.0ROR 209.9 · χ² 36,614 / p <1e-300 | 172.7 EB05 154.0 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=212 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 296 | 203.3 179.8–229.9ROR 206.6 · χ² 50,311 / p <1e-300 | 170.5 EB05 154.8 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=296 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| X-ray abnormal | 269 | 203.0 178.4–230.9ROR 206.0 · χ² 45,637 / p <1e-300 | 170.1 EB05 153.7 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=269 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Facet joint syndrome | 432 | 181.6 164.2–200.8ROR 185.9 · χ² 66,663 / p <1e-300 | 155.4 EB05 143.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious n=432 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Pulmonary septal thickening | 12 | 175.5 95.6–322.5ROR 175.7 · χ² 1,654 / p <1e-300 | 122.8 EB05 74.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Retinitis | 221 | 174.4 151.5–200.9ROR 176.6 · χ² 32,854 / p <1e-300 | 149.3 EB05 133.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=221 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 254 | 164.8 144.6–187.9ROR 167.1 · χ² 35,937 / p <1e-300 | 142.4 EB05 128.3 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=254 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Dislocation of vertebra | 265 | 154.6 136.1–175.6ROR 156.8 · χ² 35,426 / p <1e-300 | 134.7 EB05 121.7 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=265 · ♀ 100% (drug 63%) · 91% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 836 | 146.9 136.9–157.7ROR 153.9 · χ² 107,081 / p <1e-300 | 129.7 EB05 122.5 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 84.2 · ♀ 100% (drug 63%) · 93% clinician | NCT00619359: 1/1,143 (0.1%) on Aprepitant (serious AE) |
| Sleep disorder due to general medical condition, insomnia type | 708 | 141.2 130.8–152.5ROR 146.9 · χ² 87,497 / p <1e-300 | 125.2 EB05 117.6 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=708 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Swollen joint count increased | 343 | 141.2 126.3–157.8ROR 143.9 · χ² 42,315 / p <1e-300 | 124.7 EB05 114.0 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=343 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 718 | 128.4 119.1–138.6ROR 133.6 · χ² 81,408 / p <1e-300 | 115.0 EB05 108.2 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious PRR 75.0 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Computerised tomogram thorax abnormal | 66 | 119.5 92.8–154.0ROR 120.0 · χ² 6,906 / p <1e-300 | 104.9 EB05 85.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=66 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 410 | 118.4 107.0–130.9ROR 121.0 · χ² 43,077 / p <1e-300 | 106.7 EB05 98.3 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=410 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Muscle injury | 769 | 118.1 109.8–127.1ROR 123.3 · χ² 80,767 / p <1e-300 | 106.7 EB05 100.6 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious PRR 75.1 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Nail bed inflammation | 29 | 114.6 78.2–167.9ROR 114.8 · χ² 2,862 / p <1e-300 | 97.6 EB05 71.3 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 100% (drug 63%) | not reported in cached trials |
| Helicobacter infection | 860 | 105.3 98.3–112.7ROR 110.4 · χ² 81,175 / p <1e-300 | 96.2 EB05 90.9 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 66.0 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Folliculitis | 870 | 105.1 98.2–112.5ROR 110.3 · χ² 81,989 / p <1e-300 | 96.0 EB05 90.8 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 73.3 · ♀ 99% (drug 63%) · 94% clinician | not reported in cached trials |
| Rheumatoid factor positive | 435 | 93.2 84.6–102.6ROR 95.4 · χ² 36,553 / p <1e-300 | 85.8 EB05 79.2 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=435 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Tonsillar haemorrhage | 11 | 91.8 49.7–169.7ROR 91.8 · χ² 831 / p 4e-183 | 74.4 EB05 44.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Intestinal strangulation | 12 | 90.7 50.4–163.3ROR 90.8 · χ² 904 / p 6e-199 | 74.5 EB05 45.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Bone erosion | 250 | 86.7 76.3–98.6ROR 87.9 · χ² 19,594 / p <1e-300 | 80.1 EB05 72.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=250 · ♀ 100% (drug 63%) · 98% clinician | not reported in cached trials |
| C-reactive protein abnormal | 431 | 82.4 74.8–90.8ROR 84.3 · χ² 32,223 / p <1e-300 | 76.6 EB05 70.7 · IC025 +6.0 3/3 methods agree | Lab value / disease marker | serious n=431 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Eosinophil percentage decreased | 13 | 81.8 46.6–143.6ROR 81.9 · χ² 893 / p 1e-196 | 68.9 EB05 42.9 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Hand deformity | 873 | 81.7 76.4–87.3ROR 85.7 · χ² 64,829 / p <1e-300 | 76.1 EB05 72.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 53.7 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Peripheral venous disease | 263 | 80.5 71.1–91.2ROR 81.7 · χ² 19,207 / p <1e-300 | 74.8 EB05 67.5 · IC025 +5.8 3/3 methods agree | Labeled (related wording) related wording | serious n=262 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Intestinal scarring | 12 | 79.5 44.3–142.8ROR 79.6 · χ² 797 / p 1e-175 | 66.8 EB05 40.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Chemotherapeutic drug level increased | 10 | 70.4 37.2–133.3ROR 70.4 · χ² 580 / p 2e-128 | 59.2 EB05 34.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=10 | not reported in cached trials |
| Subcutaneous drug absorption impaired | 31 | 68.9 47.9–99.0ROR 69.0 · χ² 1,891 / p <1e-300 | 62.6 EB05 46.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Pemphigus | 701 | 68.3 63.3–73.6ROR 70.9 · χ² 43,762 / p <1e-300 | 64.3 EB05 60.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 41.9 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Aprepitant as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (1 of 40 signal terms matched).
- NCT00619359 — Evaluation of Fosaprepitant (MK0517) in Single Dose Schedule (0517-017) (N=2322, PHASE3; 184 AE terms posted; arms: Fosaprepitant; Aprepitant)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 | 2,245 | 3.3 3.1–3.4ROR 3.6 · χ² 3,637 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.5 | NCT00619359: 3/1,169 (0.3%) on Aprepitant (serious AE) |
| Fatigue (tiredness) | 1,943 | 2.9 2.7–3.0ROR 3.1 · χ² 2,437 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | NCT00619359: 1/1,169 (0.1%) on Aprepitant (serious AE) |
| Pyrexia (fever) | 1,653 | 5.5 5.2–5.7ROR 5.9 · χ² 6,116 / p <1e-300 | 5.4 EB05 5.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · 92% clinician | NCT00619359: 2/1,169 (0.2%) on Aprepitant (serious AE) |
| Diarrhoea (diarrhea) | 1,603 | 2.9 2.7–3.0ROR 3.0 · χ² 1,982 / p <1e-300 | 2.8 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | NCT00619359: 8/1,169 (0.7%) on Aprepitant (serious AE) |
| Dyspnoea (shortness of breath) | 1,583 | 3.2 3.1–3.4ROR 3.4 · χ² 2,457 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · ♀ 84% (drug 63%) | NCT00619359: 5/1,169 (0.4%) on Aprepitant (serious AE) |
| Vomiting | 1,542 | 3.8 3.6–4.0ROR 4.0 · χ² 3,192 / p <1e-300 | 3.8 EB05 3.6 · IC025 +1.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 3.3 | NCT00619359: 7/1,169 (0.6%) on Aprepitant (serious AE) |
| Off label use (used outside approved label) | 1,423 | 1.9 1.8–2.0ROR 1.9 · χ² 604 / p 1e-133 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 2.2 | not reported in cached trials |
| Alopecia (hair loss) | 1,327 | 7.8 7.4–8.2ROR 8.3 · χ² 7,816 / p <1e-300 | 7.7 EB05 7.3 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 · ♀ 95% (drug 63%) | NCT00619359: 16/1,169 (1.4%) on Aprepitant |
| Rash | 1,269 | 3.4 3.2–3.5ROR 3.5 · χ² 2,128 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 · ♀ 86% (drug 63%) | not reported in cached trials |
| Hypersensitivity (allergic reaction) | 1,182 | 7.3 6.9–7.7ROR 7.8 · χ² 6,466 / p <1e-300 | 7.3 EB05 6.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.7 · ♀ 85% (drug 63%) · 93% clinician | not reported in cached trials |
| Decreased appetite (loss of appetite) | 1,096 | 5.4 5.1–5.7ROR 5.7 · χ² 3,979 / p <1e-300 | 5.4 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | not reported in cached trials |
| Pruritus (itching) | 1,076 | 3.3 3.1–3.5ROR 3.4 · χ² 1,709 / p <1e-300 | 3.2 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · ♀ 90% (drug 63%) · 92% clinician | not reported in cached trials |
| Febrile neutropenia | 1,076 | 18.9 17.8–20.0ROR 20.0 · χ² 17,934 / p <1e-300 | 18.6 EB05 17.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.1 · 93% clinician | NCT00619359: 27/1,169 (2.3%) on Aprepitant (serious AE) |
| Infusion related reaction (reaction during infusion) | 1,040 | 18.3 17.2–19.4ROR 19.3 · χ² 16,735 / p <1e-300 | 18.0 EB05 17.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 · ♀ 91% (drug 63%) · 94% clinician | not reported in cached trials |
| Stomatitis (mouth sores) | 1,035 | 19.8 18.7–21.0ROR 20.9 · χ² 18,206 / p <1e-300 | 19.5 EB05 18.5 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.7 · ♀ 86% (drug 63%) · 92% clinician | NCT00619359: 1/1,169 (0.1%) on Aprepitant (serious AE) |
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.
- Computerised tomogram thorax — n=39, PRR 2,091.9
- Grip strength — n=121, PRR 1,262.0
- Swollen joint count — n=93, PRR 698.4
- Lupus vulgaris — n=267, PRR 331.2
- Porphyria acute — n=212, PRR 207.5
- Deep vein thrombosis postoperative — n=296, PRR 203.3
- Facet joint syndrome — n=432, PRR 181.6
- Retinitis — n=221, PRR 174.4
- Adjustment disorder with depressed mood — n=254, PRR 164.8
- Dislocation of vertebra — n=265, PRR 154.6
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 Aprepitant?
In FDA FAERS, the most frequently co-reported reaction terms for Aprepitant are nausea, fatigue, pyrexia, diarrhoea, dyspnoea, 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 Aprepitant have an FDA boxed warning?
No. The FDA label retrieved for Aprepitant has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Aprepitant 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 4c218d3a-a508-4abc-9ed8-a6e8e191d1b4, effective 20260401; matched on
openfda.generic_name.exact:"APREPITANT") - 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, 1,102 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
APREPITANT, results-bearing studies sorted by enrollment)
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.