Alemtuzumab side effects: what 19,229 FDA adverse event reports show
Drug class
CD52-directed Cytolytic Antibody
Brand names
Lemtrada
Who reports
19,229 reports · 86% serious · 2,921 with death outcome · 59% female
Used for
LEMTRADA is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, the use of LEMTRADA should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS .
What it is
Alemtuzumab is a recombinant humanized IgG1 kappa monoclonal antibody directed against the cell surface glycoprotein, CD52. Alemtuzumab has an approximate molecular weight of 150 kD. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a nutrient medium containing neomycin.
Boxed warning
AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor comple.
Causality screen of the 40 strongest signals
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.
- 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. 1,187 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 | 18 | 2,764.7 1,154.9–6,618.6ROR 2,767.3 · χ² 13,160 / p <1e-300 | 424.2 EB05 283.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Thyroid stimulating immunoglobulin | 18 | 1,488.7 729.5–3,037.9ROR 1,490.1 · χ² 10,606 / p <1e-300 | 375.1 EB05 251.0 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Specific gravity urine decreased | 71 | 954.2 693.4–1,313.1ROR 957.8 · χ² 35,315 / p <1e-300 | 445.1 EB05 364.8 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=71 · ♀ 87% (drug 59%) | not reported in cached trials |
| Haemoglobin urine present | 80 | 705.0 532.0–934.4ROR 708.0 · χ² 33,544 / p <1e-300 | 386.7 EB05 320.6 · IC025 +6.5 3/3 methods agree | Lab value / disease marker | serious n=76 · ♀ 92% (drug 59%) | not reported in cached trials |
| Bacterial test | 111 | 648.6 512.7–820.5ROR 652.4 · χ² 44,365 / p <1e-300 | 378.4 EB05 323.0 · IC025 +6.9 3/3 methods agree | Reporting / coding artifact | serious n=109 · ♀ 88% (drug 59%) | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Urine leukocyte esterase | 22 | 639.3 377.2–1,083.4ROR 640.0 · χ² 8,396 / p <1e-300 | 297.5 EB05 207.1 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=21 · ♀ 100% (drug 59%) | not reported in cached trials |
| T-cell prolymphocytic leukaemia | 33 | 601.4 392.8–920.6ROR 602.4 · χ² 12,302 / p <1e-300 | 315.4 EB05 235.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=33 · 100% clinician | not reported in cached trials |
| Crystal urine present | 187 | 549.3 460.9–654.8ROR 554.7 · χ² 67,381 / p <1e-300 | 350.8 EB05 310.6 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=182 · ♀ 80% (drug 59%) | not reported in cached trials |
| Mucoepidermoid carcinoma of salivary gland | 19 | 537.6 310.0–932.3ROR 538.1 · χ² 6,431 / p <1e-300 | 263.7 EB05 178.4 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=19 | not reported in cached trials |
| Specific gravity urine increased | 44 | 525.6 366.6–753.6ROR 526.8 · χ² 15,124 / p <1e-300 | 306.3 EB05 237.6 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=43 | not reported in cached trials |
| Urinary sediment present | 201 | 500.3 423.4–591.0ROR 505.5 · χ² 68,010 / p <1e-300 | 330.9 EB05 294.3 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=196 · ♀ 94% (drug 59%) | not reported in cached trials |
| Urine leukocyte esterase positive | 218 | 487.3 415.5–571.5ROR 492.9 · χ² 72,468 / p <1e-300 | 326.0 EB05 291.3 · IC025 +7.3 3/3 methods agree | Lab value / disease marker | serious n=213 · ♀ 88% (drug 59%) | not reported in cached trials |
| Bilirubin urine present | 34 | 468.7 313.4–700.9ROR 469.5 · χ² 10,726 / p <1e-300 | 276.0 EB05 206.6 · IC025 +5.3 3/3 methods agree | Lab value / disease marker | serious n=34 | not reported in cached trials |
| Urobilinogen urine increased | 46 | 430.1 305.6–605.2ROR 431.1 · χ² 13,760 / p <1e-300 | 272.7 EB05 212.7 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=46 · ♀ 85% (drug 59%) | not reported in cached trials |
| Cells in urine | 22 | 430.1 262.4–705.0ROR 430.6 · χ² 6,424 / p <1e-300 | 242.8 EB05 169.0 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=22 · ♀ 100% (drug 59%) | not reported in cached trials |
| Nitrite urine present | 113 | 378.5 305.6–468.8ROR 380.7 · χ² 31,188 / p <1e-300 | 267.5 EB05 228.6 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=109 · ♀ 85% (drug 59%) | not reported in cached trials |
| Pyelonephritis fungal | 18 | 358.4 210.3–610.9ROR 358.7 · χ² 4,547 / p <1e-300 | 209.5 EB05 140.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | not reported in cached trials |
| Red blood cells urine positive | 235 | 350.0 302.3–405.2ROR 354.3 · χ² 61,430 / p <1e-300 | 258.7 EB05 232.1 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=229 · ♀ 83% (drug 59%) | not reported in cached trials |
| Band neutrophil percentage increased | 24 | 322.6 204.4–508.9ROR 323.0 · χ² 5,673 / p <1e-300 | 207.5 EB05 146.8 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=24 · 100% clinician | not reported in cached trials |
| Ph urine increased | 36 | 291.0 201.4–420.5ROR 291.6 · χ² 7,962 / p <1e-300 | 204.5 EB05 154.3 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=35 | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Autoimmune thyroid disorder | 23 | 290.9 183.6–461.1ROR 291.3 · χ² 5,004 / p <1e-300 | 192.7 EB05 135.3 · IC025 +4.6 3/3 methods agree | Labeled adverse reaction exact term | serious n=23 · ♀ 100% (drug 59%) | NCT02255656: 1/1,062 (0.1%) on Alemtuzumab (serious AE) |
| Adenovirus reactivation | 29 | 288.7 191.7–434.9ROR 289.1 · χ² 6,330 / p <1e-300 | 198.2 EB05 144.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=28 · 100% clinician | not reported in cached trials |
| Autoimmune pancytopenia | 17 | 272.8 160.2–464.4ROR 273.0 · χ² 3,458 / p <1e-300 | 175.3 EB05 115.9 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=17 | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Perineal ulceration | 26 | 254.1 165.8–389.6ROR 254.5 · χ² 5,099 / p <1e-300 | 178.9 EB05 128.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · 100% clinician | not reported in cached trials |
| Lymphocyte percentage decreased | 249 | 247.7 215.9–284.0ROR 250.9 · χ² 49,521 / p <1e-300 | 198.4 EB05 178.6 · IC025 +7.0 3/3 methods agree | Lab value / disease marker | serious n=242 | not reported in cached trials |
| Microsporidia infection | 64 | 239.8 182.9–314.3ROR 240.6 · χ² 12,248 / p <1e-300 | 185.4 EB05 150.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=64 · ♀ 0% (drug 59%) · 100% clinician | not reported in cached trials |
| Monocyte percentage increased | 118 | 218.7 179.6–266.5ROR 220.1 · χ² 21,072 / p <1e-300 | 176.8 EB05 151.6 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=116 | not reported in cached trials |
| Neutrophil percentage increased | 209 | 215.7 186.0–250.0ROR 218.0 · χ² 37,018 / p <1e-300 | 176.9 EB05 157.7 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=203 | not reported in cached trials |
| White blood cells urine positive | 290 | 200.6 177.1–227.3ROR 203.7 · χ² 48,384 / p <1e-300 | 167.4 EB05 151.8 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=283 · ♀ 89% (drug 59%) | not reported in cached trials |
| Tri-iodothyronine free increased | 26 | 191.5 126.2–290.5ROR 191.7 · χ² 4,021 / p <1e-300 | 145.5 EB05 104.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 100% (drug 59%) | not reported in cached trials |
| Herpes zoster infection neurological | 24 | 191.1 123.8–295.0ROR 191.4 · χ² 3,694 / p <1e-300 | 144.1 EB05 101.9 · IC025 +4.6 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · 100% clinician | NCT02255656: 1/1,062 (0.1%) on Alemtuzumab (serious AE) |
| Cd4 lymphocytes abnormal | 31 | 188.3 128.6–275.7ROR 188.6 · χ² 4,757 / p <1e-300 | 146.1 EB05 107.8 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=22 | not reported in cached trials |
| Immune thrombocytopenic purpura | 406 | 179.9 162.1–199.7ROR 183.8 · χ² 61,742 / p <1e-300 | 153.2 EB05 141.1 · IC025 +6.9 3/3 methods agree | Labeled (related wording) related wording | serious n=402 | NCT00930553: 16/1,314 (1.2%) on Alemtuzumab (serious AE) |
| Autoimmune neutropenia | 40 | 173.4 124.2–242.1ROR 173.8 · χ² 5,757 / p <1e-300 | 139.6 EB05 107.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=40 · 100% clinician | not reported in cached trials |
| Red cell distribution width decreased | 63 | 171.9 131.8–224.2ROR 172.5 · χ² 9,083 / p <1e-300 | 142.0 EB05 115.0 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=62 · ♀ 100% (drug 59%) | not reported in cached trials |
| Chronic graft versus host disease in intestine | 25 | 169.1 110.9–257.7ROR 169.3 · χ² 3,465 / p <1e-300 | 131.7 EB05 93.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=25 · 100% clinician | not reported in cached trials |
| Gastroenteritis adenovirus | 21 | 168.5 106.4–266.9ROR 168.7 · χ² 2,880 / p <1e-300 | 129.0 EB05 89.0 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Urinary casts | 51 | 164.7 122.7–221.0ROR 165.1 · χ² 7,053 / p <1e-300 | 135.8 EB05 107.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=49 · ♀ 81% (drug 59%) | not reported in cached trials |
| Monocyte percentage decreased | 24 | 164.4 107.0–252.5ROR 164.6 · χ² 3,240 / p <1e-300 | 128.4 EB05 90.8 · IC025 +4.5 3/3 methods agree | Lab value / disease marker | serious n=23 · ♀ 100% (drug 59%) | not reported in cached trials |
| Red blood cells urine | 37 | 161.7 114.5–228.4ROR 162.0 · χ² 4,998 / p <1e-300 | 131.3 EB05 99.5 · IC025 +5.1 3/3 methods agree | Labeled (related wording) related wording | serious n=35 · ♀ 100% (drug 59%) | 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 Alemtuzumab 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).
- NCT00930553 — An Extension Protocol for Multiple Sclerosis Patients Who Participated in Genzyme-Sponsored Studies of Alemtuz (N=1314, PHASE3; 399 AE terms posted; arms: Alemtuzumab)
- NCT02255656 — Phase IIIB-IV Long-Term Follow-up Study for Patients Who Participated in CAMMS03409 (N=1062, PHASE4; 262 AE terms posted; arms: Delayed Alemtuzumab Treatment (DAT); Initial Alemtuzumab Treatment (IAT); Alemtuzumab)
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 |
|---|---|---|---|---|---|---|
| Headache | 1,897 | 3.3 3.2–3.5ROR 3.6 · χ² 3,142 / p <1e-300 | 3.3 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 · ♀ 80% (drug 59%) | NCT00930553: 7/1,314 (0.5%) on Alemtuzumab (serious AE) |
| Fatigue (tiredness) | 1,867 | 2.6 2.5–2.7ROR 2.8 · χ² 1,944 / p <1e-300 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Pyrexia (fever) | 1,776 | 5.6 5.4–5.9ROR 6.1 · χ² 6,815 / p <1e-300 | 5.6 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | NCT00930553: 2/1,314 (0.2%) on Alemtuzumab (serious AE) |
| Off label use (used outside approved label) | 1,674 | 2.1 2.0–2.2ROR 2.2 · χ² 1,011 / p 4e-222 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 93% clinician | not reported in cached trials |
| Rash | 1,193 | 3.0 2.8–3.2ROR 3.1 · χ² 1,624 / p <1e-300 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.8 | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Nausea | 1,185 | 1.6 1.6–1.7ROR 1.7 · χ² 306 / p 1e-68 | 1.6 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 · ♀ 80% (drug 59%) | NCT00930553: 7/1,314 (0.5%) on Alemtuzumab (serious AE) |
| Drug ineffective (drug did not work) | 1,016 | 0.8 0.8–0.9ROR 0.8 · χ² 32 / p 7e-9 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 984 | 1.9 1.8–2.0ROR 1.9 · χ² 429 / p 2e-95 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.6 | NCT00930553: 3/1,314 (0.2%) on Alemtuzumab (serious AE) |
| Asthenia (weakness) | 939 | 2.7 2.6–2.9ROR 2.8 · χ² 1,042 / p 7e-229 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.4 | not reported in cached trials |
| Multiple sclerosis relapse | 911 | 14.6 13.7–15.5ROR 15.2 · χ² 11,368 / p <1e-300 | 14.4 EB05 13.6 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.1 | NCT00930553: 67/1,314 (5.1%) on Alemtuzumab (serious AE) |
| Lymphocyte count decreased | 878 | 56.9 53.3–60.9ROR 59.6 · χ² 45,817 / p <1e-300 | 54.1 EB05 51.1 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 42.3 | NCT02255656: 2/1,062 (0.2%) on Alemtuzumab (serious AE) |
| Cytomegalovirus infection | 840 | 58.0 54.2–62.1ROR 60.6 · χ² 44,615 / p <1e-300 | 55.0 EB05 52.0 · IC025 +5.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 37.2 · 96% clinician | not reported in cached trials |
| Urinary tract infection (bladder infection) | 823 | 5.3 5.0–5.7ROR 5.5 · χ² 2,875 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · ♀ 81% (drug 59%) | NCT00930553: 1/1,314 (0.1%) on Alemtuzumab (serious AE) |
| Pain | 753 | 1.3 1.2–1.4ROR 1.3 · χ² 65 / p 4e-16 | 1.3 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.2 | NCT00930553: 11/1,314 (0.8%) on Alemtuzumab (serious AE) |
| Condition aggravated | 721 | 2.6 2.4–2.8ROR 2.7 · χ² 722 / p 3e-159 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 | 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.
- Urine leukocyte esterase — n=22, PRR 639.3
- T-cell prolymphocytic leukaemia — n=33, PRR 601.4
- Adenovirus reactivation — n=29, PRR 288.7
- Perineal ulceration — n=26, PRR 254.1
- Microsporidia infection — n=64, PRR 239.8
- Tri-iodothyronine free increased — n=26, PRR 191.5
- Chronic graft versus host disease in intestine — n=25, PRR 169.1
- Gastroenteritis adenovirus — n=21, PRR 168.5
- Urinary casts — n=51, PRR 164.7
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 Alemtuzumab?
In FDA FAERS, the most frequently co-reported reaction terms for Alemtuzumab are headache, fatigue, pyrexia, rash, nausea, dyspnoea. 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 Alemtuzumab have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: AUTOIMMUNITY, INFUSION REACTIONS, STROKE, AND MALIGNANCIES LEMTRADA causes serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia and anti-glomerular basement membrane disease. Monitor comple.
Do FAERS signals prove that Alemtuzumab 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 6236b0bc-82e9-4447-9a78-f57d94770269, effective 20251103; matched on
openfda.generic_name.exact:"ALEMTUZUMAB") - 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, 1,227 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
ALEMTUZUMAB, 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.