Thalidomide side effects: what 36,495 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Thalomid
Who reports
36,495 reports · 89% serious · 12,161 with death outcome · 44% female
Used for
• THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). ( 1.1 ) • THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL). THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.
What it is
THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent.
Boxed warning
EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO -FETAL TOXICITY • If THALOMID is taken during pregnancy, it can cause severe birth defects or embryo-fetal death.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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, 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). 1,133 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 |
|---|---|---|---|---|---|---|
| Actinomycotic sepsis | 17 | 1,202.6 519.0–2,786.4ROR 1,203.1 · calibrated p 6e-14 ✓ | 269.0 EB05 177.9 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Blood human chorionic gonadotropin increased | 113 | 633.2 484.2–827.9ROR 635.1 · calibrated p 1e-14 ✓ | 284.9 EB05 243.5 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=113 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Blood human chorionic gonadotropin abnormal | 16 | 503.0 256.5–986.4ROR 503.3 · calibrated p 1e-11 ✓ | 202.6 EB05 132.2 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=16 | not reported in cached trials |
| Leukaemia plasmacytic | 45 | 217.7 154.4–306.9ROR 217.9 · calibrated p 6e-10 ✓ | 147.7 EB05 114.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=44 · 100% clinician | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Myeloma recurrence | 24 | 178.7 113.0–282.8ROR 178.8 · calibrated p 6e-9 ✓ | 123.0 EB05 87.0 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious n=24 | not reported in cached trials |
| Type 2 lepra reaction | 43 | 170.2 121.0–239.3ROR 170.4 · calibrated p 4e-9 ✓ | 124.0 EB05 95.9 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=40 · ♀ 0% (drug 44%) · 100% clinician | not reported in cached trials |
| Multiple myeloma | 856 | 127.0 118.1–136.7ROR 130.1 · calibrated p 2e-8 ✓ | 103.7 EB05 98.0 · IC025 +6.5 3/3 methods agree | Labeled — boxed warning exact term | serious n=850 · 94% clinician | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Pseudomyopia | 18 | 107.2 64.8–177.5ROR 107.3 · calibrated p 3e-7 ✓ | 82.6 EB05 55.3 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Ivth nerve paralysis | 34 | 101.3 70.3–145.9ROR 101.4 · calibrated p 2e-7 ✓ | 82.2 EB05 61.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 0% (drug 44%) · 100% clinician | not reported in cached trials |
| Medulloblastoma | 20 | 88.4 55.2–141.6ROR 88.5 · calibrated p 1e-6 ✓ | 71.6 EB05 48.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Hepatosplenic t-cell lymphoma | 44 | 76.9 56.1–105.3ROR 76.9 · calibrated p 1e-6 ✓ | 65.9 EB05 51.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 44%) · 91% clinician | not reported in cached trials |
| Plasmacytoma | 212 | 73.1 63.4–84.3ROR 73.5 · calibrated p 1e-6 ✓ | 64.5 EB05 57.5 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=211 | NCT00689936: 3/541 (0.6%) on Thalidomide (serious AE) |
| Plasmacytosis | 19 | 62.9 39.1–101.0ROR 62.9 · calibrated p 9e-6 ✓ | 53.8 EB05 36.4 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Wound debridement | 39 | 58.5 42.1–81.4ROR 58.6 · calibrated p 8e-6 ✓ | 51.9 EB05 39.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=40 · 100% clinician | not reported in cached trials |
| Plasma cell leukaemia | 55 | 58.1 44.0–76.6ROR 58.2 · calibrated p 8e-6 ✓ | 51.9 EB05 41.3 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=55 | not reported in cached trials |
| Plasma cell myeloma refractory | 119 | 58.1 48.1–70.1ROR 58.2 · calibrated p 6e-6 ✓ | 52.3 EB05 44.9 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=119 · 100% clinician | not reported in cached trials |
| Plasma cell myeloma recurrent | 297 | 57.4 50.9–64.6ROR 57.8 · calibrated p 6e-6 ✓ | 52.0 EB05 47.2 · IC025 +5.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=288 | not reported in cached trials |
| Neuropathy | 151 | 55.1 46.6–65.1ROR 55.3 · calibrated p 8e-6 ✓ | 50.0 EB05 43.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=146 · 92% clinician | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Complications of bone marrow transplant | 32 | 55.0 38.3–79.1ROR 55.1 · calibrated p 1e-5 ✓ | 48.9 EB05 36.3 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=32 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Dental treatment | 21 | 54.0 34.5–84.5ROR 54.1 · calibrated p 2e-5 ✓ | 47.4 EB05 32.7 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=20 | not reported in cached trials |
| Bone debridement | 41 | 52.6 38.2–72.4ROR 52.7 · calibrated p 2e-5 ✓ | 47.2 EB05 36.3 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=41 · 100% clinician | not reported in cached trials |
| Refractory cancer | 18 | 52.0 32.1–84.2ROR 52.0 · calibrated p 3e-5 ✓ | 45.5 EB05 30.5 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Carcinoma | 21 | 47.9 30.7–74.8ROR 47.9 · calibrated p 4e-5 ✓ | 42.7 EB05 29.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=21 | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Primary sequestrum | 65 | 43.7 34.0–56.3ROR 43.8 · calibrated p 4e-5 ✓ | 40.2 EB05 32.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=64 | not reported in cached trials |
| Aseptic necrosis bone | 56 | 43.7 33.3–57.3ROR 43.7 · calibrated p 4e-5 ✓ | 40.1 EB05 32.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=56 · 100% clinician | not reported in cached trials |
| Pregnancy of partner | 50 | 43.1 32.3–57.4ROR 43.1 · calibrated p 5e-5 ✓ | 39.5 EB05 31.2 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 0% (drug 44%) | not reported in cached trials |
| Tuberculosis of central nervous system | 17 | 39.1 23.9–63.9ROR 39.1 · calibrated p 1e-4 ✓ | 35.3 EB05 23.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Morganella infection | 18 | 37.5 23.2–60.3ROR 37.5 · calibrated p 2e-4 ✓ | 34.0 EB05 22.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Paraproteinaemia | 18 | 35.0 21.7–56.3ROR 35.0 · calibrated p 2e-4 ✓ | 32.0 EB05 21.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Congenital aplasia | 16 | 33.5 20.3–55.5ROR 33.6 · calibrated p 3e-4 ✓ | 30.7 EB05 20.0 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Actinomycosis | 53 | 33.3 25.3–44.0ROR 33.4 · calibrated p 2e-4 ✓ | 31.2 EB05 24.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=52 | not reported in cached trials |
| Human chorionic gonadotropin increased | 48 | 32.6 24.4–43.6ROR 32.6 · calibrated p 2e-4 ✓ | 30.5 EB05 23.9 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=42 · ♀ 100% (drug 44%) · 100% clinician | not reported in cached trials |
| Sequestrectomy | 36 | 32.4 23.2–45.4ROR 32.5 · calibrated p 3e-4 ✓ | 30.3 EB05 22.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=35 | not reported in cached trials |
| Oral soft tissue disorder | 18 | 32.2 20.1–51.8ROR 32.3 · calibrated p 4e-4 ✓ | 29.7 EB05 19.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Exposure via body fluid | 42 | 32.1 23.5–43.8ROR 32.2 · calibrated p 3e-4 ✓ | 30.1 EB05 23.2 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=42 · ♀ 100% (drug 44%) | not reported in cached trials |
| Plasma cell myeloma | 2,030 | 31.4 30.1–32.8ROR 33.2 · calibrated p 2e-4 ✓ | 29.8 EB05 28.7 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.3 · 92% clinician | not reported in cached trials |
| B-cell type acute leukaemia | 37 | 31.2 22.4–43.4ROR 31.2 · calibrated p 3e-4 ✓ | 29.2 EB05 22.1 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=37 · 100% clinician | not reported in cached trials |
| Renal cell carcinoma stage unspecified | 28 | 29.3 20.1–42.9ROR 29.4 · calibrated p 5e-4 ✓ | 27.5 EB05 20.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Amyloidosis | 84 | 29.3 23.6–36.5ROR 29.4 · calibrated p 3e-4 ✓ | 27.8 EB05 23.1 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=82 | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Cellulitis staphylococcal | 30 | 27.6 19.1–39.8ROR 27.6 · calibrated p 6e-4 ✓ | 26.0 EB05 19.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=28 · ♀ 65% (drug 44%) · 100% 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 Thalidomide 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 (6 of 40 signal terms matched).
- NCT00689936 — Study to Determine Efficacy and Safety of Lenalidomide Plus Low-dose Dexamethasone Versus Melphalan, Prednison (N=1623, PHASE3; 705 AE terms posted; arms: Lenalidomide and Low-Dose Dexamethasone ; Lenalidomide and Dexamethasone (Rd18); Melphalan + Prednisone + Thalidomide (MP)
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 |
|---|---|---|---|---|---|---|
| Death | 6,412 | 4.3 4.2–4.4ROR 5.0 · calibrated p 0.234 | 4.3 EB05 4.2 · IC025 +2.1 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 2.8 | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Disease progression | 2,495 | 12.4 11.9–12.9ROR 13.2 · calibrated p 0.012 ✓ | 12.2 EB05 11.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 · 96% clinician | not reported in cached trials |
| Plasma cell myeloma | 2,030 | 31.4 30.1–32.8ROR 33.2 · calibrated p 2e-4 ✓ | 29.8 EB05 28.7 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 20.3 · 92% clinician | not reported in cached trials |
| Neuropathy peripheral (nerve damage in hands/feet) | 1,823 | 11.3 10.8–11.8ROR 11.8 · calibrated p 0.018 ✓ | 11.1 EB05 10.6 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.5 | NCT00689936: 1/541 (0.2%) on Thalidomide (serious AE) |
| Off label use (used outside approved label) | 1,785 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.434 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.1 | not reported in cached trials |
| Pneumonia (lung infection) | 1,713 | 3.1 2.9–3.2ROR 3.2 · calibrated p 0.578 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00689936: 1/540 (0.2%) on Thalidomide (serious AE) |
| Fatigue (tiredness) | 1,410 | 1.0 1.0–1.1ROR 1.0 · calibrated p 0.336 | 1.0 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 1.0 | NCT00689936: 3/541 (0.6%) on Thalidomide (serious AE) |
| Drug ineffective (drug did not work) | 1,148 | 0.5 0.5–0.5ROR 0.5 · calibrated p 0.044 ✓ | 0.5 EB05 0.5 · IC025 -1.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | not reported in cached trials |
| Anaemia (low red blood cells) | 1,023 | 3.1 2.9–3.3ROR 3.2 · calibrated p 0.579 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | NCT00689936: 23/541 (4.3%) on Thalidomide (serious AE) |
| Asthenia (weakness) | 1,021 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.692 | 1.6 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT00689936: 5/541 (0.9%) on Thalidomide (serious AE) |
| Constipation | 996 | 2.7 2.5–2.8ROR 2.7 · calibrated p 0.733 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.5 | NCT00689936: 5/541 (0.9%) on Thalidomide (serious AE) |
| Dyspnoea (shortness of breath) | 991 | 1.0 0.9–1.1ROR 1.0 · calibrated p 0.311 | 1.0 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled — boxed warning synonym match | serious PRR 0.8 | NCT00689936: 8/541 (1.5%) on Thalidomide (serious AE) |
| Pyrexia (fever) | 960 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.713 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled (related wording) related wording | serious PRR 1.2 | NCT00689936: 1/540 (0.2%) on Thalidomide (serious AE) |
| Thrombocytopenia (low platelets) | 879 | 4.6 4.3–4.9ROR 4.6 · calibrated p 0.277 | 4.5 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 · 91% clinician | NCT00689936: 10/541 (1.8%) on Thalidomide (serious AE) |
| Nausea | 865 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.094 | 0.6 EB05 0.6 · IC025 -0.8 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | NCT00689936: 7/541 (1.3%) on Thalidomide (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.
- Leukaemia plasmacytic — n=45, PRR 217.7 (also seen in trial arm)
- Type 2 lepra reaction — n=43, PRR 170.2
- Ivth nerve paralysis — n=34, PRR 101.3
- Medulloblastoma — n=20, PRR 88.4
- Hepatosplenic t-cell lymphoma — n=44, PRR 76.9
- Plasmacytoma — n=212, PRR 73.1 (also seen in trial arm)
- Wound debridement — n=39, PRR 58.5
- Bone debridement — n=41, PRR 52.6
- Carcinoma — n=21, PRR 47.9 (also seen in trial arm)
- Primary sequestrum — n=65, PRR 43.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Thalidomide ↔ Abnormal/increased blood hCG.
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 Thalidomide?
In FDA FAERS, the most frequently co-reported reaction terms for Thalidomide are plasma cell myeloma, neuropathy peripheral, pneumonia, fatigue, anaemia, asthenia. 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 Thalidomide have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM WARNING: EMBRYO-FETAL TOXICITY AND VENOUS THROMBOEMBOLISM See full prescribing information for complete boxed warning. EMBRYO -FETAL TOXICITY • If THALOMID is taken during pregnancy, it can cause severe birth defects or embryo-fetal death.
Do FAERS signals prove that Thalidomide 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 2eda833b-1357-4ed4-a093-194524fcb061, effective 20230324; matched on
openfda.generic_name.exact:"THALIDOMIDE") - 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, 1,173 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
THALIDOMIDE, 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.