Drug · FAERS side-effect profile with label screen
Apremilast side effects: what 145,474 FDA adverse event reports show
Drug class
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Otezla
openFDA label
Who reports
145,474 reports · 24% serious · 5,952 with death outcome · 66% female
openFDA FAERS counts, all years, deduplication not applied
Used for
OTEZLA/OTEZLA XR, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis ( 1.1 ) Plaque psoriasis who are candidates for phototherapy or systemic therapy ( 1.2 ) Oral ulcers associ.
FDA label, Indications and Usage
What it is
Apremilast is a member of the class of isoindoles that is isoindole-1,3-dione substituted at position 4 by an acetamido group and at position 1 by a 1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl group.
PubChem CID 11561674 (ChEBI)
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 2Labeled (related wording) 1Likely indication confounding 3Lab value / disease marker 8Not in label — unassessed 26
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.
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,130 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 |
|---|---|---|---|---|---|---|
| Anti-cyclic citrullinated peptide antibody | 430 | 265.2 225.9–311.3ROR 266.0 · calibrated p 4e-11 ✓ | 92.4 EB05 85.3 · IC025 +6.2 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=430 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| C-reactive protein | 497 | 175.9 154.2–200.7ROR 176.5 · calibrated p 1e-9 ✓ | 78.7 EB05 73.0 · IC025 +6.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=497 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Hepatic enzyme | 75 | 168.1 120.3–235.0ROR 168.2 · calibrated p 5e-9 ✓ | 75.9 EB05 62.5 · IC025 +5.3 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=75 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Lupus vulgaris | 602 | 148.4 132.4–166.3ROR 149.0 · calibrated p 5e-9 ✓ | 72.7 EB05 68.0 · IC025 +6.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=602 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 975 | 143.3 131.1–156.6ROR 144.3 · calibrated p 7e-9 ✓ | 71.5 EB05 67.8 · IC025 +6.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=975 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Rheumatic fever | 2,152 | 140.7 132.6–149.3ROR 142.8 · calibrated p 7e-9 ✓ | 70.9 EB05 68.5 · IC025 +6.1 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=2,152 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Swollen joint count increased | 1,531 | 139.7 130.2–149.9ROR 141.2 · calibrated p 8e-9 ✓ | 70.7 EB05 67.7 · IC025 +6.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=1,531 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Grip strength | 111 | 132.9 102.5–172.2ROR 133.0 · calibrated p 2e-8 ✓ | 68.2 EB05 58.2 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=111 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Swollen joint count | 115 | 126.9 98.6–163.2ROR 127.0 · calibrated p 3e-8 ✓ | 66.6 EB05 57.0 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Labeled adverse reaction exact term | serious n=115 · ♀ 100% (drug 66%) · 95% clinician | not reported in cached trials |
| Red blood cell sedimentation rate | 130 | 124.1 98.0–157.0ROR 124.2 · calibrated p 3e-8 ✓ | 65.9 EB05 56.9 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=130 · 92% clinician | not reported in cached trials |
| Facet joint syndrome | 1,377 | 112.1 104.5–120.3ROR 113.2 · calibrated p 4e-8 ✓ | 62.9 EB05 60.1 · IC025 +5.9 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=1,377 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 207 | 88.3 74.2–105.1ROR 88.5 · calibrated p 3e-7 ✓ | 54.5 EB05 48.5 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=207 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 765 | 88.2 80.6–96.5ROR 88.7 · calibrated p 3e-7 ✓ | 54.6 EB05 51.4 · IC025 +5.6 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=760 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Retinitis | 603 | 81.5 73.7–90.1ROR 81.8 · calibrated p 5e-7 ✓ | 52.0 EB05 48.6 · IC025 +5.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=603 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Dislocation of vertebra | 767 | 75.8 69.5–82.7ROR 76.2 · calibrated p 8e-7 ✓ | 49.6 EB05 46.7 · IC025 +5.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=767 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| X-ray abnormal | 599 | 72.7 65.9–80.3ROR 73.0 · calibrated p 1e-6 ✓ | 48.3 EB05 45.1 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=599 · ♀ 100% (drug 66%) · 98% clinician | not reported in cached trials |
| Hypocholesterolaemia | 95 | 64.2 50.4–81.8ROR 64.2 · calibrated p 4e-6 ✓ | 44.1 EB05 37.1 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=94 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,750 | 62.7 59.2–66.3ROR 63.4 · calibrated p 3e-6 ✓ | 43.7 EB05 42.0 · IC025 +5.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=1,750 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 2,094 | 60.1 57.1–63.2ROR 61.0 · calibrated p 4e-6 ✓ | 42.4 EB05 40.9 · IC025 +5.3 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious PRR 103.9 · ♀ 98% (drug 66%) · 96% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 2,155 | 59.8 56.9–62.9ROR 60.7 · calibrated p 4e-6 ✓ | 42.3 EB05 40.8 · IC025 +5.3 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious PRR 103.0 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 28 | 55.7 36.0–86.3ROR 55.7 · calibrated p 2e-5 ✓ | 39.2 EB05 28.5 · IC025 +3.9 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=28 · ♀ 100% (drug 66%) · 100% clinician | not reported in cached trials |
| Peripheral venous disease | 1,015 | 49.0 45.6–52.6ROR 49.3 · calibrated p 1e-5 ✓ | 36.6 EB05 34.7 · IC025 +5.1 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=1,013 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Seronegative arthritis | 283 | 48.4 42.3–55.4ROR 48.5 · calibrated p 2e-5 ✓ | 36.2 EB05 32.8 · IC025 +4.9 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Likely indication confounding shares a disease stem with the indications wording | serious n=283 · ♀ 97% (drug 66%) · 95% clinician | not reported in cached trials |
| C-reactive protein abnormal | 1,577 | 46.9 44.3–49.7ROR 47.4 · calibrated p 2e-5 ✓ | 35.5 EB05 34.0 · IC025 +5.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Lab value / disease marker | serious n=1,572 · ♀ 91% (drug 66%) · 95% clinician | not reported in cached trials |
| Bone erosion | 854 | 45.6 42.3–49.3ROR 45.9 · calibrated p 2e-5 ✓ | 34.7 EB05 32.8 · IC025 +5.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 935.6 (444.7–1,968.2) | Not in label — unassessed | serious n=854 · ♀ 96% (drug 66%) · 92% clinician | not reported in cached trials |
| Enthesopathy | 359 | 42.3 37.6–47.6ROR 42.4 · calibrated p 4e-5 ✓ | 32.7 EB05 30.0 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=344 | not reported in cached trials |
| Tender joint count | 19 | 41.3 24.8–68.8ROR 41.3 · calibrated p 1e-4 ✓ | 31.3 EB05 21.2 · IC025 +3.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Labeled (related wording) related wording | serious n=19 | not reported in cached trials |
| Helicobacter infection | 2,129 | 37.9 36.1–39.8ROR 38.5 · calibrated p 7e-5 ✓ | 30.1 EB05 29.0 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious PRR 77.4 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Psoriatic arthropathy | 8,175 | 36.6 35.8–37.5ROR 38.8 · calibrated p 6e-5 ✓ | 29.3 EB05 28.8 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 2,022.3 (1,421.6–2,876.8) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 62.7 | not reported in cached trials |
| Folliculitis | 2,075 | 36.1 34.4–37.9ROR 36.6 · calibrated p 9e-5 ✓ | 28.9 EB05 27.9 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 1,224.1 (709.7–2,111.3) | Labeled adverse reaction exact term | serious PRR 81.6 · ♀ 99% (drug 66%) · 96% clinician | not reported in cached trials |
| Muscle injury | 1,586 | 34.4 32.6–36.3ROR 34.8 · calibrated p 1e-4 ✓ | 27.8 EB05 26.7 · IC025 +4.7 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious PRR 73.4 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Hand deformity | 2,406 | 32.3 30.9–33.8ROR 32.9 · calibrated p 2e-4 ✓ | 26.5 EB05 25.6 · IC025 +4.7 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 2,050.1 (1,065.5–3,944.5) | Not in label — unassessed | serious PRR 70.1 · ♀ 99% (drug 66%) · 96% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, insomnia type | 1,166 | 31.7 29.8–33.8ROR 32.0 · calibrated p 2e-4 ✓ | 26.1 EB05 24.9 · IC025 +4.6 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 2,235.4 (837.7–5,965.7) | Not in label — unassessed | serious n=1,149 · ♀ 99% (drug 66%) · 96% clinician | not reported in cached trials |
| Pemphigus | 2,213 | 31.1 29.7–32.5ROR 31.5 · calibrated p 2e-4 ✓ | 25.6 EB05 24.8 · IC025 +4.6 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious PRR 62.7 · ♀ 100% (drug 66%) · 96% clinician | not reported in cached trials |
| Granuloma skin | 143 | 29.9 25.0–35.8ROR 29.9 · calibrated p 3e-4 ✓ | 24.8 EB05 21.6 · IC025 +4.2 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=143 · 92% clinician | not reported in cached trials |
| Breast cancer stage iii | 1,069 | 28.6 26.8–30.5ROR 28.8 · calibrated p 3e-4 ✓ | 23.9 EB05 22.8 · IC025 +4.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=1,069 · ♀ 100% (drug 66%) · 97% clinician | not reported in cached trials |
| Synovitis | 2,981 | 28.4 27.3–29.5ROR 29.0 · calibrated p 3e-4 ✓ | 23.8 EB05 23.1 · IC025 +4.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious PRR 60.8 · ♀ 95% (drug 66%) · 95% clinician | not reported in cached trials |
| Onychomadesis | 678 | 28.0 25.8–30.4ROR 28.1 · calibrated p 4e-4 ✓ | 23.5 EB05 22.1 · IC025 +4.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=645 · ♀ 98% (drug 66%) · 94% clinician | not reported in cached trials |
| Psoriasis | 20,585 | 26.8 26.4–27.2ROR 31.1 · calibrated p 2e-4 ✓ | 22.7 EB05 22.4 · IC025 +4.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 1,169.3 (987.8–1,384.3) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 24.7 · serious PRR 26.3 | not reported in cached trials |
| Overlap syndrome | 108 | 26.6 21.7–32.7ROR 26.6 · calibrated p 6e-4 ✓ | 22.5 EB05 19.1 · IC025 +4.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: only this drug | Not in label — unassessed | serious n=108 · ♀ 100% (drug 66%) · 92% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Depression | 5,989 | 3.13.0–3.2 | signal |
| Liver injury | 3,772 | 1.81.8–1.9 | raised |
| Tendon disorder | 431 | 1.61.5–1.8 | raised |
| Interstitial lung disease | 992 | 1.51.4–1.6 | raised |
| Hyperglycaemia / diabetes | 3,060 | 1.31.2–1.3 | raised |
| Serious infection | 6,029 | 1.11.1–1.2 | raised |
| Opportunistic infection | 674 | 0.70.7–0.8 | lower than other drugs |
| Pancreatitis | 357 | 0.60.6–0.7 | lower than other drugs |
| Malignancy | 1,394 | 0.50.5–0.6 | lower than other drugs |
| Fall / fracture | 1,357 | 0.50.5–0.5 | lower than other drugs |
| Suicidality | 752 | 0.40.4–0.5 | lower than other drugs |
| Rhabdomyolysis / myopathy | 237 | 0.40.4–0.5 | lower than other drugs |
| Gi bleeding | 488 | 0.40.4–0.4 | lower than other drugs |
| Myocardial infarction | 392 | 0.30.2–0.3 | lower than other drugs |
| Arrhythmia / qt | 351 | 0.30.2–0.3 | lower than other drugs |
| Stroke | 423 | 0.20.2–0.3 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Apremilast 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).
- NCT03611751 — An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Av (N=1020, PHASE3; 48 AE terms posted; arms: BMS-986165 (Week 0 up to Week 16); Placebo (Week 0 up to Week 16); Apremilast (Week 0 up to Week 16); BMS-986165 (Week 0 up to Week 52))
- NCT01194219 — Study to Evaluate Safety and Effectiveness of Oral Apremilast (CC-10004) in Patients With Moderate to Severe P (N=844, PHASE3; 99 AE terms posted; arms: Placebo (Placebo-Controlled Phase) Weeks; Apremilast (Placebo-Controlled Phase) We; APR-APR-PBO Randomized Withdrawal Phase ; Apremilast (Apremilast Exposure Period) )
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 |
|---|---|---|---|---|---|---|
| Diarrhoea (diarrhea) | 24,624 | 5.7 5.6–5.8ROR 6.7 · calibrated p 0.113 | 5.5 EB05 5.5 · IC025 +2.4 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 292.8 (271.1–316.2) | Labeled adverse reaction exact term | age-adj. PRR 5.8 · serious PRR 4.7 | NCT03611751: 35/254 (13.8%) on Apremilast; 19/254 (7.5%) control |
| Nausea | 22,177 | 4.1 4.1–4.2ROR 4.7 · calibrated p 0.269 | 4.1 EB05 4.0 · IC025 +2.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 312.6 (287.4–340.0) | Labeled adverse reaction exact term | age-adj. PRR 4.0 · serious PRR 4.1 | NCT03611751: 26/254 (10.2%) on Apremilast; 3/254 (1.2%) control |
| Psoriasis | 20,585 | 26.8 26.4–27.2ROR 31.1 · calibrated p 2e-4 ✓ | 22.7 EB05 22.4 · IC025 +4.5 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 1,169.3 (987.8–1,384.3) | Likely indication confounding term in indications; also in warnings | age-adj. PRR 24.7 · serious PRR 26.3 | not reported in cached trials |
| Headache | 17,913 | 4.2 4.2–4.3ROR 4.7 · calibrated p 0.273 | 4.1 EB05 4.1 · IC025 +2.0 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 283.8 (259.6–310.3) | Labeled adverse reaction exact term | age-adj. PRR 4.0 · serious PRR 5.1 | NCT03611751: 30/254 (11.8%) on Apremilast; 14/254 (5.5%) control |
| Drug ineffective (drug did not work) | 15,565 | 1.7 1.7–1.7ROR 1.8 · calibrated p 0.828 | 1.7 EB05 1.7 · IC025 +0.7 vs other Phosphodiesterase 4 Inhibitors: PRR 60.1 (57.5–62.9) | Reporting / coding artifact | age-adj. PRR 1.6 · serious PRR 3.8 | not reported in cached trials |
| Abdominal discomfort | 8,234 | 7.4 7.3–7.6ROR 7.8 · calibrated p 0.072 | 7.1 EB05 7.0 · IC025 +2.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 505.2 (423.6–602.5) | Not in label — unassessed | age-adj. PRR 8.2 · serious PRR 13.7 | not reported in cached trials |
| Psoriatic arthropathy | 8,175 | 36.6 35.8–37.5ROR 38.8 · calibrated p 6e-5 ✓ | 29.3 EB05 28.8 · IC025 +4.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 2,022.3 (1,421.6–2,876.8) | Likely indication confounding shares a disease stem with the indications wording | serious PRR 62.7 | not reported in cached trials |
| Pain | 6,927 | 1.6 1.6–1.7ROR 1.7 · calibrated p 0.745 | 1.6 EB05 1.6 · IC025 +0.7 vs other Phosphodiesterase 4 Inhibitors: PRR 100.6 (92.2–109.8) | Labeled adverse reaction exact term | age-adj. PRR 1.7 · serious PRR 3.2 | NCT01194219: 1/804 (0.1%) on Apremilast; 1/560 (0.2%) control (serious AE) |
| Rash | 6,776 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.887 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 84.4 (77.8–91.5) | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 6.0 | not reported in cached trials |
| Vomiting | 6,555 | 2.0 2.0–2.1ROR 2.1 · calibrated p 0.986 | 2.0 EB05 2.0 · IC025 +1.0 vs other Phosphodiesterase 4 Inhibitors: PRR 1,621.6 (1,139.7–2,307.1) | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 3.3 | not reported in cached trials |
| Arthralgia (joint pain) | 6,436 | 2.3 2.2–2.3ROR 2.3 · calibrated p 0.895 | 2.2 EB05 2.2 · IC025 +1.1 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 796.1 (620.1–1,021.9) | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 5.4 | NCT01194219: 51/804 (6.3%) on Apremilast; 5/282 (1.8%) control |
| Fatigue (tiredness) | 6,225 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.415 | 1.2 EB05 1.1 · IC025 +0.2 vs other Phosphodiesterase 4 Inhibitors: PRR 723.3 (567.7–921.5) | Labeled adverse reaction exact term | age-adj. PRR 1.3 · serious PRR 3.1 | not reported in cached trials |
| Depression | 5,572 | 3.6 3.5–3.7ROR 3.7 · calibrated p 0.442 | 3.5 EB05 3.4 · IC025 +1.8 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 224.9 (194.7–259.7) | Labeled adverse reaction exact term | age-adj. PRR 3.1 · serious PRR 5.1 | NCT03611751: 1/501 (0.2%) on Apremilast; 1/254 (0.4%) control (serious AE) |
| Off label use (used outside approved label) | 5,291 | 0.9 0.9–0.9ROR 0.9 · calibrated p 0.227 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC vs other Phosphodiesterase 4 Inhibitors: PRR 34.3 (32.3–36.5) | Reporting / coding artifact | age-adj. PRR 1.1 · serious PRR 2.6 | not reported in cached trials |
| Weight decreased (weight loss) | 5,046 | 2.6 2.6–2.7ROR 2.7 · calibrated p 0.734 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree vs other Phosphodiesterase 4 Inhibitors: PRR 82.7 (75.3–90.8) | Labeled (related wording) related wording | age-adj. PRR 2.5 · serious PRR 3.7 | 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.
- Hepatic enzyme — n=75, PRR 168.1
- Lupus vulgaris — n=602, PRR 148.4
- Deep vein thrombosis postoperative — n=975, PRR 143.3
- Rheumatic fever — n=2,152, PRR 140.7
- Grip strength — n=111, PRR 132.9
- Facet joint syndrome — n=1,377, PRR 112.1
- Subcutaneous drug absorption impaired — n=207, PRR 88.3
- Adjustment disorder with depressed mood — n=765, PRR 88.2
- Retinitis — n=603, PRR 81.5
- Dislocation of vertebra — n=767, PRR 75.8
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 Apremilast?
In FDA FAERS, the most frequently co-reported reaction terms for Apremilast are diarrhoea, nausea, psoriasis, headache, abdominal discomfort, psoriatic arthropathy. 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 Apremilast have an FDA boxed warning?
No. The FDA label retrieved for Apremilast has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Apremilast 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 f6b1f516-4972-4d82-bced-113e47b41cc5, effective 20260902; matched on
openfda.generic_name.exact:"APREMILAST" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - PubChem CID 11561674 description (ChEBI)
- 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, 1,170 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
APREMILAST, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. 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.