Thyroid and Porcine side effects: what 28 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Thyroid (Thyroid)
Who reports
28 reports · 68% serious · 2 with death outcome · 88% female
Used for
Thyroid Tablets are indicated: 1. As replacement or supplemental therapy in patients with hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. This category includes cretinism, myxedema, and.
What it is
DESCRIPTION Thyroid Tablets USP for oral use are a natural preparation derived from porcine thyroid glands. (T3 liothyronine is approximately four times as potent as T4 levothyroxine on a microgram for microgram basis.) They provide 38 mcg levothyroxine (T4) and 9 mcg liothyronine (T3) per grain of thyroid.
Boxed warning
Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
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 (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. 1,008 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 |
|---|---|---|---|---|---|---|
| Tri-iodothyronine increased | 31 | 166.8 115.6–240.5ROR 167.3 · χ² 4,555 / p <1e-300 | 140.6 EB05 103.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Tri-iodothyronine decreased | 33 | 134.0 94.2–190.5ROR 134.4 · χ² 3,952 / p <1e-300 | 117.1 EB05 87.2 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Thyroxine decreased | 23 | 76.1 50.2–115.4ROR 76.3 · χ² 1,570 / p <1e-300 | 69.3 EB05 48.6 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Thyroid hormones decreased | 22 | 56.3 36.9–86.0ROR 56.4 · χ² 1,109 / p 2e-243 | 52.4 EB05 36.5 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Blood thyroid stimulating hormone abnormal | 43 | 47.4 35.0–64.1ROR 47.5 · χ² 1,860 / p <1e-300 | 45.4 EB05 35.1 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Thyroxine increased | 12 | 34.3 19.4–60.6ROR 34.3 · χ² 349 / p 4e-78 | 32.1 EB05 19.5 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Autoimmune thyroiditis | 59 | 31.5 24.4–40.7ROR 31.7 · χ² 1,686 / p <1e-300 | 30.8 EB05 24.7 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | – | no trial data cached |
| Thyroid hormones increased | 16 | 30.5 18.6–50.0ROR 30.6 · χ² 422 / p 6e-94 | 29.2 EB05 19.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Reaction to preservatives | 11 | 27.0 14.9–49.0ROR 27.0 · χ² 247 / p 6e-56 | 25.5 EB05 15.0 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blood thyroid stimulating hormone decreased | 61 | 26.9 20.9–34.6ROR 27.0 · χ² 1,474 / p <1e-300 | 26.3 EB05 21.2 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Thyroidectomy | 23 | 26.9 17.8–40.5ROR 26.9 · χ² 540 / p 9e-120 | 26.0 EB05 18.2 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | – | no trial data cached |
| Documented hypersensitivity to administered product | 10 | 24.4 13.1–45.6ROR 24.5 · χ² 199 / p 1e-45 | 22.9 EB05 12.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Bone cyst | 11 | 23.4 12.9–42.4ROR 23.4 · χ² 212 / p 3e-48 | 22.1 EB05 12.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Pre-existing condition improved | 69 | 21.9 17.3–27.7ROR 22.0 · χ² 1,339 / p 2e-293 | 21.5 EB05 17.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=2 | no trial data cached |
| Nail growth abnormal | 12 | 21.7 12.3–38.4ROR 21.7 · χ² 215 / p 7e-49 | 20.6 EB05 12.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Blood thyroid stimulating hormone increased | 99 | 21.4 17.6–26.1ROR 21.6 · χ² 1,890 / p <1e-300 | 21.2 EB05 17.9 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Lyme disease | 33 | 19.9 14.1–28.0ROR 19.9 · χ² 567 / p 1e-125 | 19.5 EB05 14.5 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Thyroid function test abnormal | 41 | 19.6 14.4–26.7ROR 19.7 · χ² 699 / p 2e-154 | 19.3 EB05 14.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Allergy to chemicals | 12 | 19.3 10.9–34.0ROR 19.3 · χ² 188 / p 4e-43 | 18.2 EB05 10.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Adrenal disorder | 15 | 15.6 9.4–25.9ROR 15.6 · χ² 189 / p 3e-43 | 14.6 EB05 8.7 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Allergic reaction to excipient | 14 | 14.2 8.4–23.9ROR 14.2 · χ² 157 / p 2e-36 | 13.0 EB05 7.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Gluten sensitivity | 10 | 14.0 7.5–26.0ROR 14.0 · χ² 107 / p 2e-25 | 12.1 EB05 6.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Goitre | 24 | 11.6 7.8–17.4ROR 11.6 · χ² 221 / p 2e-50 | 10.8 EB05 7.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=1 | no trial data cached |
| Cervical spinal stenosis | 10 | 11.5 6.2–21.4ROR 11.5 · χ² 85 / p 1e-20 | 9.4 EB05 4.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Thyroid disorder | 87 | 11.2 9.1–13.9ROR 11.3 · χ² 797 / p 1e-175 | 11.0 EB05 9.1 · IC025 +3.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | – | no trial data cached |
| Trichorrhexis | 15 | 10.7 6.4–17.7ROR 10.7 · χ² 122 / p 1e-28 | 9.3 EB05 5.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Snoring | 20 | 10.5 6.8–16.4ROR 10.6 · χ² 163 / p 2e-37 | 9.5 EB05 6.2 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Vulvovaginal dryness | 17 | 10.5 6.5–16.9ROR 10.5 · χ² 136 / p 9e-32 | 9.3 EB05 5.8 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product size issue | 28 | 10.5 7.2–15.2ROR 10.5 · χ² 229 / p 4e-52 | 9.7 EB05 6.8 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product odour abnormal | 54 | 10.3 7.9–13.5ROR 10.4 · χ² 444 / p 6e-99 | 10.0 EB05 7.8 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product formulation issue | 32 | 9.6 6.8–13.6ROR 9.7 · χ² 238 / p 6e-54 | 8.9 EB05 6.5 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Product administration interrupted | 37 | 9.6 6.9–13.2ROR 9.6 · χ² 275 / p 5e-62 | 9.0 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Infusion site bruising | 10 | 9.3 5.0–17.4ROR 9.4 · χ² 66 / p 2e-16 | 7.3 EB05 4.0 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Middle ear effusion | 10 | 9.0 4.9–16.8ROR 9.1 · χ² 63 / p 8e-16 | 7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Reaction to drug excipients | 10 | 9.0 4.8–16.8ROR 9.0 · χ² 63 / p 9e-16 | 7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hormone level abnormal | 21 | 8.7 5.7–13.3ROR 8.7 · χ² 134 / p 2e-31 | 7.7 EB05 5.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | – | no trial data cached |
| Infusion site haemorrhage | 14 | 8.6 5.1–14.5ROR 8.6 · χ² 86 / p 9e-21 | 7.1 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Menopause | 11 | 8.6 4.7–15.5ROR 8.6 · χ² 66 / p 2e-16 | 6.8 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Hypothyroidism | 133 | 8.3 7.0–9.8ROR 8.4 · χ² 844 / p 6e-186 | 8.1 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | – | no trial data cached |
| Animal bite | 11 | 8.3 4.6–15.0ROR 8.3 · χ² 63 / p 1e-15 | 6.6 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 1,057 | 2.7 2.5–2.9ROR 2.9 · χ² 1,168 / p 3e-256 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Drug ineffective (drug did not work) | 932 | 1.4 1.3–1.5ROR 1.4 · χ² 114 / p 6e-27 | 1.4 EB05 1.3 · IC025 +0.4 | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Headache | 802 | 2.5 2.4–2.7ROR 2.7 · χ² 768 / p 3e-169 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Nausea | 791 | 2.0 1.9–2.1ROR 2.1 · χ² 401 / p 2e-89 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Pain | 589 | 1.9 1.8–2.1ROR 1.9 · χ² 256 / p 7e-58 | 1.9 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Dizziness | 556 | 2.2 2.0–2.4ROR 2.3 · χ² 377 / p 3e-84 | 2.2 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Diarrhoea (diarrhea) | 520 | 1.6 1.5–1.7ROR 1.6 · χ² 120 / p 3e-28 | 1.6 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.7 | no trial data cached |
| Off label use (used outside approved label) | 509 | 1.2 1.1–1.3ROR 1.2 · χ² 12 / p 3e-4 | 1.2 EB05 1.1 · IC025 +0.1 | Reporting / coding artifact | serious PRR 1.4 | no trial data cached |
| Feeling abnormal | 473 | 3.9 3.6–4.3ROR 4.0 · χ² 1,026 / p 2e-225 | 3.9 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Arthralgia (joint pain) | 448 | 2.1 2.0–2.3ROR 2.2 · χ² 277 / p 2e-62 | 2.1 EB05 2.0 · IC025 +0.9 | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Malaise (feeling unwell) | 436 | 2.0 1.8–2.2ROR 2.0 · χ² 210 / p 8e-48 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | – | no trial data cached |
| Anxiety | 434 | 3.0 2.7–3.3ROR 3.1 · χ² 590 / p 2e-130 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 433 | 1.5 1.4–1.7ROR 1.5 · χ² 78 / p 6e-19 | 1.5 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.6 | no trial data cached |
| Insomnia (trouble sleeping) | 409 | 3.0 2.8–3.3ROR 3.1 · χ² 564 / p 6e-125 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Asthenia (weakness) | 374 | 2.0 1.8–2.2ROR 2.0 · χ² 181 / p 2e-41 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
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.
- Tri-iodothyronine increased — n=31, PRR 166.8
- Tri-iodothyronine decreased — n=33, PRR 134.0
- Pre-existing condition improved — n=69, PRR 21.9
- Lyme disease — n=33, PRR 19.9
- Goitre — n=24, PRR 11.6
- Snoring — n=20, PRR 10.5
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 Thyroid and Porcine?
In FDA FAERS, the most frequently co-reported reaction terms for Thyroid and Porcine are fatigue, headache, nausea, pain, dizziness, 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 Thyroid and Porcine have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: Drugs with thyroid hormone activity, alone or together with other therapeutic agents, have been used for the treatment of obesity. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
Do FAERS signals prove that Thyroid and Porcine 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 9b517204-3d73-410f-aa86-741f29e51906, effective 20250804; matched on
openfda.generic_name.exact:"THYROID") - 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, 1,048 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.