Teriparatide side effects: what 112,086 FDA adverse event reports show
Drug class
Parathyroid Hormone Analog
Who reports
112,086 reports · 37% serious · 5,304 with death outcome · 91% female
Used for
Teriparatide Injection is indicated: For the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined herein as having a history of osteoporotic fracture or multiple risk factors for fracture) or who have failed or are intolerant to other available osteoporosis therapy.
What it is
Teriparatide Injection is a recombinant human parathyroid hormone analog (PTH 1-34). It has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.
Boxed warning
None in the current label
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.
- 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). 1,182 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 |
|---|---|---|---|---|---|---|
| Injection site stinging | 104 | 134.5 104.4–173.2ROR 134.6 · calibrated p 2e-8 ✓ | 77.0 EB05 65.3 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Muscle cramp | 552 | 82.7 74.8–91.5ROR 83.1 · calibrated p 5e-7 ✓ | 57.2 EB05 53.3 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=79 | not reported in cached trials |
| Urine calcium increased | 87 | 71.3 55.7–91.3ROR 71.4 · calibrated p 2e-6 ✓ | 51.1 EB05 42.7 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | 84% consumer | not reported in cached trials |
| Growing pains | 72 | 69.6 53.1–91.3ROR 69.6 · calibrated p 2e-6 ✓ | 50.1 EB05 41.1 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Vertebroplasty | 108 | 59.7 48.1–74.2ROR 59.8 · calibrated p 5e-6 ✓ | 45.0 EB05 38.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=91 | not reported in cached trials |
| Blood calcium increased | 2,041 | 56.6 53.9–59.4ROR 57.6 · calibrated p 5e-6 ✓ | 43.5 EB05 41.9 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=626 · 80% consumer | not reported in cached trials |
| Chest wall pain | 73 | 51.0 39.3–66.0ROR 51.0 · calibrated p 2e-5 ✓ | 39.7 EB05 32.6 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Injection site burning | 147 | 42.6 35.6–51.0ROR 42.7 · calibrated p 4e-5 ✓ | 34.7 EB05 30.2 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | 100% clinician | not reported in cached trials |
| Injection site streaking | 45 | 40.5 29.3–55.9ROR 40.5 · calibrated p 7e-5 ✓ | 32.9 EB05 25.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | 100% consumer | not reported in cached trials |
| Osteitis deformans | 50 | 34.4 25.4–46.5ROR 34.4 · calibrated p 2e-4 ✓ | 28.8 EB05 22.7 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=32 | not reported in cached trials |
| Buttock pain | 35 | 31.8 22.2–45.5ROR 31.8 · calibrated p 3e-4 ✓ | 26.9 EB05 20.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Pain exacerbated | 35 | 31.8 22.2–45.5ROR 31.8 · calibrated p 3e-4 ✓ | 26.9 EB05 20.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Vitamin d increased | 74 | 25.5 20.0–32.5ROR 25.5 · calibrated p 7e-4 ✓ | 22.4 EB05 18.4 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=20 · 100% consumer | not reported in cached trials |
| Bone fissure | 46 | 23.1 17.0–31.4ROR 23.1 · calibrated p 0.001 ✓ | 20.5 EB05 16.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=43 | not reported in cached trials |
| Medial tibial stress syndrome | 37 | 22.3 15.9–31.4ROR 22.4 · calibrated p 0.002 ✓ | 19.8 EB05 15.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Vitamin d abnormal | 39 | 19.9 14.3–27.7ROR 19.9 · calibrated p 0.003 ✓ | 17.9 EB05 13.6 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | 100% consumer | not reported in cached trials |
| Blood parathyroid hormone decreased | 130 | 17.8 14.9–21.3ROR 17.8 · calibrated p 0.004 ✓ | 16.3 EB05 14.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications | serious n=33 · 80% consumer | not reported in cached trials |
| Fear of falling | 70 | 17.8 13.9–22.7ROR 17.8 · calibrated p 0.004 ✓ | 16.2 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=19 · 100% consumer | not reported in cached trials |
| Compression fracture | 450 | 17.6 16.0–19.4ROR 17.7 · calibrated p 0.004 ✓ | 16.2 EB05 14.9 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=337 · 75% consumer | NCT01343004: 2/818 (0.2%) on Teriparatide (serious AE) |
| Device operational issue | 364 | 17.6 15.8–19.6ROR 17.6 · calibrated p 0.004 ✓ | 16.1 EB05 14.8 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | 81% consumer | not reported in cached trials |
| Vitamin d decreased | 671 | 15.8 14.6–17.1ROR 15.9 · calibrated p 0.005 ✓ | 14.6 EB05 13.7 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious n=144 · 89% consumer | not reported in cached trials |
| Lower extremity mass | 47 | 15.1 11.2–20.3ROR 15.1 · calibrated p 0.008 ✓ | 13.8 EB05 10.7 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Difficulty in walking | 261 | 15.1 13.3–17.1ROR 15.1 · calibrated p 0.007 ✓ | 14.0 EB05 12.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=82 | not reported in cached trials |
| Pelvic fracture | 573 | 14.8 13.6–16.1ROR 14.9 · calibrated p 0.007 ✓ | 13.8 EB05 12.9 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 21.3 | NCT01343004: 1/820 (0.1%) control (serious AE) |
| Pubis fracture | 53 | 14.7 11.1–19.5ROR 14.7 · calibrated p 0.009 ✓ | 13.5 EB05 10.6 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=53 | not reported in cached trials |
| Accidental needle stick | 60 | 14.3 11.0–18.7ROR 14.4 · calibrated p 0.009 ✓ | 13.2 EB05 10.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | – | not reported in cached trials |
| Hypercalciuria | 35 | 14.2 10.1–20.1ROR 14.2 · calibrated p 0.011 ✓ | 12.9 EB05 9.5 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=20 | NCT01343004: 102/818 (12.5%) on Teriparatide; 74/820 (9.0%) control |
| Vascular injury | 101 | 14.1 11.5–17.3ROR 14.1 · calibrated p 0.010 ✓ | 13.1 EB05 11.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Bone pain | 4,131 | 14.1 13.7–14.6ROR 14.6 · calibrated p 0.008 ✓ | 13.2 EB05 12.8 · IC025 +3.7 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.6 · serious PRR 7.6 · 84% consumer | not reported in cached trials |
| Blood calcium abnormal | 115 | 13.9 11.5–16.8ROR 13.9 · calibrated p 0.010 ✓ | 12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree | Lab value / disease marker | serious n=41 · 76% consumer | not reported in cached trials |
| Pharmaceutical product complaint | 1,739 | 13.2 12.5–13.8ROR 13.4 · calibrated p 0.011 ✓ | 12.3 EB05 11.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | age-adj. PRR 23.3 · serious PRR 30.0 | not reported in cached trials |
| Spinal fracture | 1,289 | 12.9 12.2–13.6ROR 13.0 · calibrated p 0.012 ✓ | 12.1 EB05 11.5 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.8 · 73% consumer | NCT01343004: 2/818 (0.2%) on Teriparatide (serious AE) |
| Fractured sacrum | 79 | 12.7 10.1–16.0ROR 12.7 · calibrated p 0.015 ✓ | 11.8 EB05 9.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=68 | not reported in cached trials |
| Thoracic vertebral fracture | 181 | 12.2 10.5–14.2ROR 12.2 · calibrated p 0.016 ✓ | 11.4 EB05 10.1 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=144 | NCT01709110: 2/683 (0.3%) on Teriparatide (serious AE) |
| Wrist fracture | 729 | 12.1 11.2–13.0ROR 12.1 · calibrated p 0.016 ✓ | 11.4 EB05 10.7 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.1 · 72% consumer | NCT01343004: 2/818 (0.2%) on Teriparatide (serious AE) |
| Injection site bruising | 4,780 | 12.0 11.7–12.4ROR 12.5 · calibrated p 0.014 ✓ | 11.3 EB05 11.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.2 · serious PRR 10.7 · 94% consumer | not reported in cached trials |
| Lumbar vertebral fracture | 270 | 11.8 10.4–13.3ROR 11.8 · calibrated p 0.018 ✓ | 11.1 EB05 10.0 · IC025 +3.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=233 | NCT01343004: 1/818 (0.1%) on Teriparatide (serious AE) |
| Waist circumference increased | 61 | 11.5 8.9–15.0ROR 11.6 · calibrated p 0.021 ✓ | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | 100% consumer | not reported in cached trials |
| Body height decreased | 628 | 11.5 10.6–12.4ROR 11.5 · calibrated p 0.020 ✓ | 10.8 EB05 10.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=196 · 88% consumer | not reported in cached trials |
| Injection site haemorrhage | 4,507 | 11.2 10.9–11.6ROR 11.6 · calibrated p 0.019 ✓ | 10.6 EB05 10.4 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 13.5 · serious PRR 12.7 · 89% consumer | NCT01343004: 1/818 (0.1%) on Teriparatide (serious AE) |
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 |
|---|---|---|---|
| Fall / fracture | 9,776 | 4.94.8–5.0 | signal |
| Tendon disorder | 230 | 1.11.0–1.3 | no difference |
| Serious infection | 4,179 | 1.01.0–1.0 | no difference |
| Stroke | 1,304 | 1.00.9–1.0 | no difference |
| Arrhythmia / qt | 1,005 | 1.00.9–1.0 | no difference |
| Depression | 1,367 | 0.90.9–1.0 | lower than other drugs |
| Osteonecrosis | 271 | 0.90.8–1.0 | lower than other drugs |
| Heart failure | 797 | 0.80.8–0.9 | lower than other drugs |
| Hyponatraemia | 356 | 0.80.7–0.9 | lower than other drugs |
| Opportunistic infection | 596 | 0.80.8–0.9 | lower than other drugs |
| Myocardial infarction | 798 | 0.70.7–0.8 | lower than other drugs |
| Anaemia | 1,153 | 0.70.7–0.8 | lower than other drugs |
| Venous thromboembolism | 811 | 0.70.7–0.7 | lower than other drugs |
| Malignancy | 1,262 | 0.60.6–0.7 | lower than other drugs |
| Pancreatitis | 250 | 0.60.5–0.7 | lower than other drugs |
| Hypoglycaemia | 284 | 0.60.5–0.6 | lower than other drugs |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Teriparatide 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 (8 of 40 signal terms matched).
- NCT01343004 — Study to Evaluate the Safety and Efficacy of BA058 (Abaloparatide) for Prevention of Fracture in Postmenopausa (N=2463, PHASE3; 195 AE terms posted; arms: Placebo; BA058 80 mcg (Abaloparatide); Teriparatide)
- NCT01709110 — VERtebral Fracture Treatment Comparisons in Osteoporotic Women (N=1366, PHASE4; 226 AE terms posted; arms: Teriparatide; Risedronate)
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 |
|---|---|---|---|---|---|---|
| Nausea | 9,008 | 2.1 2.1–2.2ROR 2.2 · calibrated p 0.927 | 2.1 EB05 2.1 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 1.6 · 83% consumer | NCT01343004: 42/818 (5.1%) on Teriparatide; 25/820 (3.0%) control |
| Arthralgia (joint pain) | 8,705 | 4.0 3.9–4.1ROR 4.2 · calibrated p 0.335 | 3.9 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.8 · serious PRR 2.4 · 85% consumer | NCT01343004: 1/818 (0.1%) on Teriparatide; 1/820 (0.1%) control (serious AE) |
| Pain in extremity | 8,366 | 5.4 5.3–5.5ROR 5.8 · calibrated p 0.164 | 5.3 EB05 5.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | age-adj. PRR 4.8 · serious PRR 3.3 · 87% consumer | NCT01343004: 42/818 (5.1%) on Teriparatide; 49/820 (6.0%) control |
| Dizziness | 8,320 | 3.2 3.1–3.2ROR 3.3 · calibrated p 0.527 | 3.1 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.0 · serious PRR 2.3 · 82% consumer | NCT01343004: 2/818 (0.2%) on Teriparatide; 1/820 (0.1%) control (serious AE) |
| Fall | 7,917 | 4.5 4.4–4.6ROR 4.8 · calibrated p 0.256 | 4.5 EB05 4.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 3.0 · serious PRR 5.6 · 73% consumer | NCT01709110: 15/683 (2.2%) on Teriparatide (serious AE) |
| Pain | 7,563 | 2.3 2.3–2.4ROR 2.4 · calibrated p 0.852 | 2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.7 · serious PRR 1.7 · 84% consumer | NCT01343004: 1/822 (0.1%) on Teriparatide; 3/820 (0.4%) control (serious AE) |
| Fatigue (tiredness) | 7,209 | 1.7 1.7–1.8ROR 1.8 · calibrated p 0.826 | 1.7 EB05 1.7 · IC025 +0.8 | Labeled (related wording) related wording | age-adj. PRR 1.6 · serious PRR 1.3 · 82% consumer | not reported in cached trials |
| Back pain | 5,933 | 4.9 4.8–5.0ROR 5.1 · calibrated p 0.225 | 4.8 EB05 4.7 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 4.4 · serious PRR 4.2 · 84% consumer | NCT01343004: 1/818 (0.1%) on Teriparatide; 3/820 (0.4%) control (serious AE) |
| Muscle spasms | 5,749 | 6.0 5.9–6.2ROR 6.3 · calibrated p 0.132 | 5.9 EB05 5.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.6 · serious PRR 3.7 · 87% consumer | not reported in cached trials |
| Malaise (feeling unwell) | 5,685 | 2.4 2.4–2.5ROR 2.5 · calibrated p 0.807 | 2.4 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.2 · serious PRR 2.2 · 87% consumer | not reported in cached trials |
| Headache | 5,508 | 1.7 1.6–1.7ROR 1.7 · calibrated p 0.760 | 1.6 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | age-adj. PRR 2.0 · serious PRR 1.4 · 81% consumer | NCT01343004: 1/822 (0.1%) on Teriparatide (serious AE) |
| Asthenia (weakness) | 5,448 | 2.7 2.7–2.8ROR 2.8 · calibrated p 0.686 | 2.7 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.2 · serious PRR 2.2 · 81% consumer | NCT01709110: 1/683 (0.1%) on Teriparatide (serious AE) |
| Injection site erythema (redness where injected) | 5,066 | 8.0 7.8–8.2ROR 8.3 · calibrated p 0.059 | 7.7 EB05 7.5 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 10.7 · serious PRR 7.5 · 89% consumer | not reported in cached trials |
| Injection site pain (pain where injected) | 4,833 | 3.0 2.9–3.1ROR 3.1 · calibrated p 0.594 | 3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 3.6 · serious PRR 4.4 · 89% consumer | NCT01343004: 1/822 (0.1%) on Teriparatide; 3/820 (0.4%) control (serious AE) |
| Injection site bruising | 4,780 | 12.0 11.7–12.4ROR 12.5 · calibrated p 0.014 ✓ | 11.3 EB05 11.1 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | age-adj. PRR 12.2 · serious PRR 10.7 · 94% consumer | 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.
- Growing pains — n=72, PRR 69.6
- Chest wall pain — n=73, PRR 51.0
- Osteitis deformans — n=50, PRR 34.4
- Buttock pain — n=35, PRR 31.8
- Pain exacerbated — n=35, PRR 31.8
- Bone fissure — n=46, PRR 23.1
- Medial tibial stress syndrome — n=37, PRR 22.3
- Fear of falling — n=70, PRR 17.8
- Lower extremity mass — n=47, PRR 15.1
- Difficulty in walking — n=261, PRR 15.1
✓ A hand-written Bradford Hill causality assessment exists for this drug: Teriparatide ↔ Hypercalcaemia.
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 Teriparatide?
In FDA FAERS, the most frequently co-reported reaction terms for Teriparatide are nausea, arthralgia, pain in extremity, dizziness, fall, pain. 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 Teriparatide have an FDA boxed warning?
No. The FDA label retrieved for Teriparatide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Teriparatide 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 ab322675-4769-45b0-b146-14fbaa3135d0, effective 20250616; matched on
openfda.generic_name.exact:"TERIPARATIDE" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 1,222 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
TERIPARATIDE, 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.