Adalimumab-Adaz side effects: what 52,421 FDA adverse event reports show
Drug class
Brand names
Adalimumab
Who reports
52,421 reports · 93% serious · 8,010 with death outcome · 67% female
Used for
Adalimumab-adaz is a tumor necrosis factor (TNF)-blocker indicated for: • Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.
What it is
Adalimumab-adaz is a tumor necrosis factor blocker. Adalimumab-adaz is a recombinant human IgG1 monoclonal antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions.
Boxed warning
SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] .
Causality screen of the 40 strongest signals
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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.
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. 1,237 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody | 496 | 1,197.2 1,003.2–1,428.6ROR 1,208.6 · χ² 146,335 / p <1e-300 | 293.5 EB05 272.5 · IC025 +7.7 3/3 methods agree | Lab value / disease marker | serious n=496 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Lupus vulgaris | 865 | 1,097.8 964.5–1,249.5ROR 1,116.2 · χ² 249,796 / p <1e-300 | 288.5 EB05 272.7 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=865 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Hepatic enzyme | 90 | 737.7 519.7–1,047.0ROR 738.9 · χ² 22,774 / p <1e-300 | 243.9 EB05 204.5 · IC025 +6.4 3/3 methods agree | Labeled (related wording) related wording | serious n=90 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Grip strength | 141 | 630.4 483.1–822.6ROR 632.1 · χ² 33,806 / p <1e-300 | 235.1 EB05 204.3 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=141 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 1,171 | 602.2 550.0–659.4ROR 615.9 · χ² 277,520 / p <1e-300 | 237.6 EB05 226.4 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=1,171 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 167 | 591.9 465.7–752.4ROR 593.8 · χ² 39,099 / p <1e-300 | 230.7 EB05 202.8 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=167 | not reported in cached trials |
| Facet joint syndrome | 1,757 | 510.1 475.5–547.3ROR 527.8 · χ² 388,578 / p <1e-300 | 222.2 EB05 213.6 · IC025 +7.6 3/3 methods agree | Not in label — unassessed | serious n=1,757 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Swollen joint count increased | 1,719 | 497.3 463.4–533.7ROR 514.1 · χ² 375,894 / p <1e-300 | 219.7 EB05 211.1 · IC025 +7.6 3/3 methods agree | Lab value / disease marker | serious n=1,712 · ♀ 99% (drug 67%) · 95% clinician | not reported in cached trials |
| Human antichimeric antibody positive | 187 | 497.1 400.7–616.6ROR 498.9 · χ² 40,684 / p <1e-300 | 215.3 EB05 190.7 · IC025 +6.9 3/3 methods agree | Lab value / disease marker | serious n=187 · ♀ 100% (drug 67%) | not reported in cached trials |
| Rheumatic fever | 2,392 | 490.1 461.9–520.2ROR 513.5 · χ² 519,803 / p <1e-300 | 218.4 EB05 211.2 · IC025 +7.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=2,391 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Synovial fluid analysis | 47 | 474.1 310.1–724.8ROR 474.6 · χ² 9,849 / p <1e-300 | 198.3 EB05 155.1 · IC025 +5.6 3/3 methods agree | Reporting / coding artifact | serious n=47 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 485 | 464.3 407.2–529.3ROR 468.6 · χ² 102,632 / p <1e-300 | 211.7 EB05 196.4 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=485 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Chronic recurrent multifocal osteomyelitis | 57 | 423.1 291.1–615.0ROR 423.6 · χ² 11,363 / p <1e-300 | 191.4 EB05 153.2 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=56 · 100% clinician | not reported in cached trials |
| Hypocholesterolaemia | 152 | 393.4 314.3–492.5ROR 394.6 · χ² 29,552 / p <1e-300 | 192.5 EB05 168.1 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=152 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 956 | 363.7 333.3–397.0ROR 370.5 · χ² 179,522 / p <1e-300 | 188.8 EB05 178.9 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=956 · ♀ 100% (drug 67%) · 97% clinician | not reported in cached trials |
| Swollen joint count | 115 | 353.5 274.8–454.6ROR 354.2 · χ² 21,105 / p <1e-300 | 181.1 EB05 155.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=115 · ♀ 100% (drug 67%) · 100% clinician | not reported in cached trials |
| Retinitis | 778 | 351.8 319.5–387.4ROR 357.1 · χ² 143,504 / p <1e-300 | 185.4 EB05 174.7 · IC025 +7.3 3/3 methods agree | Not in label — unassessed | serious n=778 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 3,029 | 299.0 285.4–313.2ROR 317.2 · χ² 511,123 / p <1e-300 | 170.1 EB05 165.1 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious PRR 106.1 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| Dislocation of vertebra | 944 | 296.6 272.7–322.6ROR 302.1 · χ² 158,425 / p <1e-300 | 169.0 EB05 160.1 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=944 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 227 | 287.2 242.1–340.7ROR 288.4 · χ² 37,255 / p <1e-300 | 164.1 EB05 147.0 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=227 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Paradoxical psoriasis | 172 | 277.3 228.2–337.0ROR 278.2 · χ² 27,615 / p <1e-300 | 160.2 EB05 141.1 · IC025 +6.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=164 · 95% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,968 | 273.0 260.7–285.8ROR 289.3 · χ² 474,797 / p <1e-300 | 161.4 EB05 156.6 · IC025 +7.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 100.2 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| X-ray abnormal | 711 | 266.2 242.1–292.6ROR 269.8 · χ² 111,879 / p <1e-300 | 158.5 EB05 148.9 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=711 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Rheumatoid factor positive | 2,291 | 264.8 251.3–279.0ROR 276.8 · χ² 359,799 / p <1e-300 | 158.5 EB05 153.1 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=2,290 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| Musculoskeletal deformity | 86 | 230.2 176.4–300.3ROR 230.5 · χ² 12,236 / p <1e-300 | 141.1 EB05 117.8 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 100% (drug 67%) | not reported in cached trials |
| Pemphigus | 3,946 | 186.5 179.7–193.5ROR 201.6 · χ² 494,092 / p <1e-300 | 126.8 EB05 123.5 · IC025 +6.9 3/3 methods agree | Not in label — unassessed | serious PRR 79.0 · ♀ 100% (drug 67%) · 93% clinician | not reported in cached trials |
| Peripheral venous disease | 1,260 | 184.8 173.0–197.5ROR 189.4 · χ² 156,642 / p <1e-300 | 125.8 EB05 120.1 · IC025 +6.8 3/3 methods agree | Labeled (related wording) related wording | serious n=1,260 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,968 | 177.7 168.6–187.3ROR 184.6 · χ² 238,193 / p <1e-300 | 122.6 EB05 118.1 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=1,968 · ♀ 94% (drug 67%) · 93% clinician | not reported in cached trials |
| Ileocaecal resection | 101 | 175.0 138.5–221.3ROR 175.4 · χ² 11,976 / p <1e-300 | 118.8 EB05 100.6 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=101 · 100% clinician | not reported in cached trials |
| Helicobacter infection | 2,985 | 165.9 159.1–173.0ROR 175.9 · χ² 344,255 / p <1e-300 | 116.9 EB05 113.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 76.8 · ♀ 100% (drug 67%) · 95% clinician | not reported in cached trials |
| Body height below normal | 190 | 165.4 139.6–195.9ROR 166.0 · χ² 21,741 / p <1e-300 | 115.4 EB05 102.3 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=190 · ♀ 100% (drug 67%) | not reported in cached trials |
| Hand deformity | 3,773 | 162.4 156.5–168.5ROR 174.9 · χ² 428,547 / p <1e-300 | 115.2 EB05 112.1 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious PRR 77.9 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| Seronegative arthritis | 314 | 155.6 136.6–177.3ROR 156.5 · χ² 34,451 / p <1e-300 | 111.0 EB05 101.1 · IC025 +6.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=314 · ♀ 100% (drug 67%) · 94% clinician | not reported in cached trials |
| Folliculitis | 2,836 | 151.6 145.3–158.2ROR 160.2 · χ² 306,336 / p <1e-300 | 109.6 EB05 106.3 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious PRR 80.1 · ♀ 99% (drug 67%) · 96% clinician | not reported in cached trials |
| Muscle injury | 2,233 | 149.7 142.7–157.1ROR 156.3 · χ² 238,920 / p <1e-300 | 108.6 EB05 104.9 · IC025 +6.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 73.1 · ♀ 100% (drug 67%) · 96% clinician | not reported in cached trials |
| Short stature | 70 | 146.5 111.3–192.7ROR 146.7 · χ² 7,265 / p <1e-300 | 104.0 EB05 85.1 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=70 | not reported in cached trials |
| Cutaneous leishmaniasis | 62 | 130.4 97.9–173.8ROR 130.6 · χ² 5,884 / p <1e-300 | 95.4 EB05 77.1 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=61 · ♀ 33% (drug 67%) · 100% clinician | not reported in cached trials |
| Vaginal flatulence | 75 | 130.0 100.1–168.7ROR 130.2 · χ² 7,119 / p <1e-300 | 95.6 EB05 78.8 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=75 · ♀ 100% (drug 67%) | not reported in cached trials |
| Bone erosion | 866 | 129.5 120.0–139.8ROR 131.7 · χ² 82,992 / p <1e-300 | 97.5 EB05 92.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=865 · ♀ 99% (drug 67%) · 96% clinician | not reported in cached trials |
| Steroid dependence | 206 | 128.0 109.4–149.8ROR 128.5 · χ² 19,494 / p <1e-300 | 96.0 EB05 85.5 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=206 · ♀ 27% (drug 67%) · 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 Adalimumab-Adaz 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 (0 of 40 signal terms matched).
- NCT03906136 — AScalate: Treat-to-target in Axial Spondyloarthritis (N=304, PHASE3; 23 AE terms posted; arms: Secukinumab 150 mg; Secukinumab 300 mg; Adalimumab 40 mg; Other Treatment)
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 11,335 | 3.5 3.4–3.5ROR 4.1 · χ² 20,993 / p <1e-300 | 3.4 EB05 3.4 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | not reported in cached trials |
| Off label use (used outside approved label) | 9,211 | 4.3 4.2–4.4ROR 5.0 · χ² 23,868 / p <1e-300 | 4.2 EB05 4.2 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 | not reported in cached trials |
| Fatigue (tiredness) | 6,253 | 3.2 3.2–3.3ROR 3.5 · χ² 9,946 / p <1e-300 | 3.2 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.8 · ♀ 90% (drug 67%) | NCT03906136: 7/190 (3.7%) on Adalimumab-Adaz |
| Rheumatoid arthritis | 6,248 | 23.3 22.8–23.9ROR 26.4 · χ² 126,757 / p <1e-300 | 22.1 EB05 21.6 · IC025 +4.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 16.7 · ♀ 95% (drug 67%) | not reported in cached trials |
| Pain | 6,234 | 4.1 4.0–4.2ROR 4.5 · χ² 14,785 / p <1e-300 | 4.0 EB05 4.0 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 · ♀ 89% (drug 67%) | not reported in cached trials |
| Arthralgia (joint pain) | 6,078 | 5.9 5.8–6.1ROR 6.6 · χ² 25,069 / p <1e-300 | 5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 88% (drug 67%) | NCT03906136: 7/190 (3.7%) on Adalimumab-Adaz |
| Rash | 5,153 | 4.8 4.7–4.9ROR 5.2 · χ² 15,614 / p <1e-300 | 4.7 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · ♀ 92% (drug 67%) | not reported in cached trials |
| Condition aggravated | 4,886 | 6.6 6.4–6.7ROR 7.1 · χ² 22,966 / p <1e-300 | 6.5 EB05 6.3 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | not reported in cached trials |
| Diarrhoea (diarrhea) | 4,724 | 3.0 2.9–3.0ROR 3.1 · χ² 6,233 / p <1e-300 | 2.9 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | NCT03906136: 1/190 (0.5%) on Adalimumab-Adaz (serious AE) |
| Drug intolerance | 4,585 | 20.0 19.4–20.5ROR 21.8 · χ² 78,912 / p <1e-300 | 19.0 EB05 18.6 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 19.2 · ♀ 93% (drug 67%) | not reported in cached trials |
| Nausea | 4,495 | 2.3 2.2–2.3ROR 2.4 · χ² 3,353 / p <1e-300 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.7 · ♀ 91% (drug 67%) | NCT03906136: 12/190 (6.3%) on Adalimumab-Adaz |
| Systemic lupus erythematosus | 4,477 | 57.9 56.2–59.6ROR 63.2 · χ² 218,452 / p <1e-300 | 50.6 EB05 49.3 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 32.2 · ♀ 96% (drug 67%) · 93% clinician | not reported in cached trials |
| Joint swelling | 4,474 | 15.4 15.0–15.8ROR 16.7 · χ² 58,231 / p <1e-300 | 14.8 EB05 14.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 15.6 · ♀ 95% (drug 67%) | not reported in cached trials |
| Headache | 4,457 | 2.9 2.8–2.9ROR 3.0 · χ² 5,510 / p <1e-300 | 2.8 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 | NCT03906136: 12/190 (6.3%) on Adalimumab-Adaz |
| Alopecia (hair loss) | 4,259 | 8.8 8.6–9.1ROR 9.5 · χ² 29,158 / p <1e-300 | 8.6 EB05 8.4 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · ♀ 98% (drug 67%) · 90% clinician | not reported in cached trials |
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.
- Lupus vulgaris — n=865, PRR 1,097.8
- Grip strength — n=141, PRR 630.4
- Deep vein thrombosis postoperative — n=1,171, PRR 602.2
- Facet joint syndrome — n=1,757, PRR 510.1
- Chronic recurrent multifocal osteomyelitis — n=57, PRR 423.1
- Hypocholesterolaemia — n=152, PRR 393.4
- Adjustment disorder with depressed mood — n=956, PRR 363.7
- Swollen joint count — n=115, PRR 353.5
- Retinitis — n=778, PRR 351.8
- Dislocation of vertebra — n=944, PRR 296.6
✓ A hand-written Bradford Hill causality assessment exists for this drug: TNF-inhibitors (adalimumab) ↔ Drug-induced lupus.
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 Adalimumab-Adaz?
In FDA FAERS, the most frequently co-reported reaction terms for Adalimumab-Adaz are fatigue, rheumatoid arthritis, pain, arthralgia, rash, diarrhoea. 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 Adalimumab-Adaz have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: SERIOUS INFECTIONS and MALIGNANCY SERIOUS INFECTIONS Patients treated with adalimumab products, including Adalimumab-adaz, are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 )] .
Do FAERS signals prove that Adalimumab-Adaz 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 3468792f-63ef-4916-8ed1-8214f327d9dd, effective 20251021; matched on
openfda.generic_name.exact:"ADALIMUMAB-ADAZ" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,277 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
ADALIMUMAB-ADAZ, 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.