Drug · FAERS side-effect profile with label screen
Teprotumumab side effects: what 241 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
241 reports · 71% serious · 1 with death outcome · 71% female
openFDA FAERS counts, all years, deduplication not applied
Used for
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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
Reporting / coding artifact 2Lab value / disease marker 5No label text to screen 33
What the badges mean
- 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.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
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. 156 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 |
|---|---|---|---|---|---|---|
| Ear discomfort | 212 | 78.2 68.4–89.4ROR 81.2 · χ² 15,746 / p <1e-300 | 76.1 EB05 67.8 · IC025 +5.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Tinnitus (ringing in the ears) | 597 | 48.6 45.0–52.4ROR 54.2 · χ² 27,472 / p <1e-300 | 47.9 EB05 44.8 · IC025 +5.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Diplopia (double vision) | 322 | 46.4 41.7–51.6ROR 49.1 · χ² 14,095 / p <1e-300 | 45.7 EB05 41.7 · IC025 +5.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hypoacusis | 477 | 41.5 38.1–45.3ROR 45.2 · χ² 18,641 / p <1e-300 | 41.0 EB05 38.0 · IC025 +5.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Impaired quality of life | 158 | 41.0 35.2–47.9ROR 42.2 · χ² 6,067 / p <1e-300 | 40.4 EB05 35.4 · IC025 +4.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Deafness | 282 | 40.2 35.9–45.1ROR 42.3 · χ² 10,643 / p <1e-300 | 39.7 EB05 36.0 · IC025 +5.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Product use complaint | 137 | 33.0 27.9–38.9ROR 33.8 · χ² 4,179 / p <1e-300 | 32.5 EB05 28.2 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Amenorrhoea (missed periods) | 128 | 28.6 24.0–33.9ROR 29.2 · χ² 3,353 / p <1e-300 | 28.2 EB05 24.4 · IC025 +4.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Economic problem | 98 | 23.7 19.4–28.8ROR 24.1 · χ² 2,091 / p <1e-300 | 23.4 EB05 19.8 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Muscle spasms | 1,117 | 22.6 21.5–23.9ROR 27.9 · χ² 23,132 / p <1e-300 | 22.5 EB05 21.4 · IC025 +4.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Glycosylated haemoglobin increased | 130 | 19.2 16.2–22.7ROR 19.6 · χ² 2,212 / p <1e-300 | 19.0 EB05 16.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Disability | 97 | 18.2 14.9–22.2ROR 18.5 · χ² 1,554 / p <1e-300 | 18.1 EB05 15.2 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Taste disorder | 95 | 17.6 14.4–21.5ROR 17.9 · χ² 1,466 / p <1e-300 | 17.5 EB05 14.7 · IC025 +3.7 3/3 methods agree | No label text to screen | – | no trial data cached |
| Ocular discomfort | 51 | 17.4 13.3–22.9ROR 17.6 · χ² 771 / p 7e-170 | 17.2 EB05 13.6 · IC025 +3.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Blood thyroid stimulating hormone increased | 43 | 17.3 12.8–23.3ROR 17.4 · χ² 641 / p 1e-141 | 17.1 EB05 13.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Discomfort | 232 | 14.2 12.5–16.1ROR 14.8 · χ² 2,830 / p <1e-300 | 14.1 EB05 12.6 · IC025 +3.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hyperglycaemia (high blood sugar) | 139 | 14.2 12.0–16.7ROR 14.5 · χ² 1,688 / p <1e-300 | 14.1 EB05 12.2 · IC025 +3.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Ear pain | 67 | 12.8 10.1–16.2ROR 12.9 · χ² 714 / p 1e-157 | 12.6 EB05 10.2 · IC025 +3.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Photophobia (light sensitivity) | 64 | 12.7 10.0–16.2ROR 12.8 · χ² 677 / p 1e-149 | 12.5 EB05 10.0 · IC025 +3.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Diabetes mellitus | 243 | 11.8 10.4–13.3ROR 12.2 · χ² 2,384 / p <1e-300 | 11.7 EB05 10.5 · IC025 +3.3 3/3 methods agree | No label text to screen | – | no trial data cached |
| Lacrimation increased | 90 | 11.2 9.1–13.7ROR 11.3 · χ² 822 / p 6e-181 | 11.0 EB05 9.1 · IC025 +3.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Inflammatory bowel disease | 29 | 10.9 7.6–15.7ROR 11.0 · χ² 251 / p 8e-57 | 10.3 EB05 7.2 · IC025 +2.6 3/3 methods agree | No label text to screen | – | no trial data cached |
| Eye pain | 151 | 10.1 8.7–11.9ROR 10.4 · χ² 1,234 / p 1e-270 | 10.0 EB05 8.7 · IC025 +3.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Madarosis | 30 | 9.5 6.6–13.6ROR 9.5 · χ² 219 / p 7e-50 | 8.8 EB05 6.3 · IC025 +2.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Dry eye | 123 | 9.4 7.9–11.2ROR 9.6 · χ² 915 / p 2e-201 | 9.2 EB05 7.9 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Vitamin d deficiency | 23 | 8.7 5.8–13.1ROR 8.8 · χ² 150 / p 1e-34 | 7.8 EB05 5.3 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Emotional distress | 281 | 8.6 7.6–9.6ROR 9.0 · χ² 1,877 / p <1e-300 | 8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Blood glucose increased | 437 | 8.6 7.8–9.4ROR 9.2 · χ² 2,929 / p <1e-300 | 8.5 EB05 7.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Alopecia (hair loss) | 432 | 8.1 7.4–8.9ROR 8.7 · χ² 2,715 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Deformity | 20 | 7.9 5.1–12.2ROR 7.9 · χ² 114 / p 8e-27 | 6.9 EB05 4.6 · IC025 +2.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Quality of life decreased | 28 | 7.7 5.3–11.2ROR 7.8 · χ² 157 / p 3e-36 | 7.0 EB05 5.0 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Eye disorder | 68 | 7.7 6.1–9.7ROR 7.8 · χ² 388 / p 9e-87 | 7.4 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hyperthyroidism | 30 | 7.7 5.4–11.0ROR 7.7 · χ² 167 / p 1e-38 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Eye swelling | 76 | 7.6 6.1–9.5ROR 7.7 · χ² 430 / p 9e-96 | 7.3 EB05 6.0 · IC025 +2.5 3/3 methods agree | No label text to screen | – | no trial data cached |
| Vitreous floaters | 19 | 7.2 4.6–11.3ROR 7.2 · χ² 96 / p 7e-23 | 6.3 EB05 4.2 · IC025 +1.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Blood glucose abnormal | 35 | 7.0 5.0–9.7ROR 7.0 · χ² 174 / p 5e-40 | 6.5 EB05 4.8 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Ageusia (loss of taste) | 47 | 7.0 5.2–9.3ROR 7.0 · χ² 234 / p 5e-53 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Temperature intolerance | 19 | 6.9 4.4–10.8ROR 6.9 · χ² 90 / p 1e-21 | 6.0 EB05 4.0 · IC025 +1.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Blood pressure systolic increased | 35 | 6.6 4.8–9.2ROR 6.6 · χ² 161 / p 3e-37 | 6.1 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Injury | 126 | 6.6 5.6–7.8ROR 6.7 · χ² 594 / p 1e-131 | 6.5 EB05 5.6 · IC025 +2.4 3/3 methods agree | No label text to screen | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Muscle spasms | 1,117 | 22.6 21.5–23.9ROR 27.9 · χ² 23,132 / p <1e-300 | 22.5 EB05 21.4 · IC025 +4.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Fatigue (tiredness) | 783 | 3.7 3.5–4.0ROR 4.2 · χ² 1,620 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Tinnitus (ringing in the ears) | 597 | 48.6 45.0–52.4ROR 54.2 · χ² 27,472 / p <1e-300 | 47.9 EB05 44.8 · IC025 +5.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Headache | 481 | 2.8 2.6–3.1ROR 3.0 · χ² 589 / p 2e-130 | 2.8 EB05 2.6 · IC025 +1.4 3/3 methods agree | No label text to screen | – | no trial data cached |
| Hypoacusis | 477 | 41.5 38.1–45.3ROR 45.2 · χ² 18,641 / p <1e-300 | 41.0 EB05 38.0 · IC025 +5.1 3/3 methods agree | No label text to screen | – | no trial data cached |
| Diarrhoea (diarrhea) | 450 | 2.6 2.4–2.8ROR 2.7 · χ² 450 / p 3e-100 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Nausea | 444 | 2.1 1.9–2.3ROR 2.2 · χ² 258 / p 2e-58 | 2.1 EB05 1.9 · IC025 +0.9 | No label text to screen | – | no trial data cached |
| Blood glucose increased | 437 | 8.6 7.8–9.4ROR 9.2 · χ² 2,929 / p <1e-300 | 8.5 EB05 7.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Alopecia (hair loss) | 432 | 8.1 7.4–8.9ROR 8.7 · χ² 2,715 / p <1e-300 | 8.1 EB05 7.4 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
| Pain | 358 | 2.2 1.9–2.4ROR 2.2 · χ² 226 / p 2e-51 | 2.1 EB05 2.0 · IC025 +0.9 | No label text to screen | – | no trial data cached |
| Anxiety | 345 | 4.5 4.0–5.0ROR 4.7 · χ² 939 / p 2e-206 | 4.4 EB05 4.1 · IC025 +2.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Diplopia (double vision) | 322 | 46.4 41.7–51.6ROR 49.1 · χ² 14,095 / p <1e-300 | 45.7 EB05 41.7 · IC025 +5.2 3/3 methods agree | No label text to screen | – | no trial data cached |
| Weight decreased (weight loss) | 310 | 4.1 3.7–4.6ROR 4.3 · χ² 736 / p 3e-162 | 4.1 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen | – | no trial data cached |
| Deafness | 282 | 40.2 35.9–45.1ROR 42.3 · χ² 10,643 / p <1e-300 | 39.7 EB05 36.0 · IC025 +5.0 3/3 methods agree | No label text to screen | – | no trial data cached |
| Emotional distress | 281 | 8.6 7.6–9.6ROR 9.0 · χ² 1,877 / p <1e-300 | 8.5 EB05 7.7 · IC025 +2.9 3/3 methods agree | No label text to screen | – | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
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 Teprotumumab?
In FDA FAERS, the most frequently co-reported reaction terms for Teprotumumab are muscle spasms, fatigue, tinnitus, headache, hypoacusis, 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 Teprotumumab have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that Teprotumumab 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 196 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
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.