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Teriparatide side effects: what 112,086 FDA adverse event reports show

Teriparatide · 1,222 reaction terms · 371,590 drug–reaction co-reports · data 2026-09-14
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Drug class

Parathyroid Hormone Analog

FDA label (Established Pharmacologic Class)

Who reports

112,086 reports · 37% serious · 5,304 with death outcome · 91% female

openFDA FAERS counts, all years, deduplication not applied

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.

FDA label, Indications and Usage

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.

FDA label, Description section

Boxed warning

None in the current label

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

Labeled adverse reaction 1Labeled (related wording) 7Likely indication confounding 10Reporting / coding artifact 1Lab value / disease marker 6Not in label — unassessed 15
What the badges mean

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.

Show:
ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Urine calcium increased8771.3
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 marker84% consumernot reported in cached trials
Growing pains7269.6
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 — unassessed100% consumernot reported in cached trials
Vertebroplasty10859.7
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=91not reported in cached trials
Blood calcium increased2,04156.6
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 markerserious n=626 · 80% consumernot reported in cached trials
Chest wall pain7351.0
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 — unassessedserious n=20 · 100% cliniciannot reported in cached trials
Osteitis deformans5034.4
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 — unassessedserious n=32not reported in cached trials
Buttock pain3531.8
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 exacerbated3531.8
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 increased7425.5
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 markerserious n=20 · 100% consumernot reported in cached trials
Bone fissure4623.1
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 — unassessedserious n=43not reported in cached trials
Medial tibial stress syndrome3722.3
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 — unassessed100% consumernot reported in cached trials
Vitamin d abnormal3919.9
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 marker100% consumernot reported in cached trials
Blood parathyroid hormone decreased13017.8
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% consumernot reported in cached trials
Fear of falling7017.8
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 — unassessedserious n=19 · 100% consumernot reported in cached trials
Compression fracture45017.6
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% consumerNCT01343004: 2/818 (0.2%) on Teriparatide (serious AE)
Device operational issue36417.6
15.8–19.6ROR 17.6 · calibrated p 0.004 ✓
16.1 EB05 14.8 · IC025 +3.8
3/3 methods agree
Reporting / coding artifact81% consumernot reported in cached trials
Vitamin d decreased67115.8
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 markerserious n=144 · 89% consumernot reported in cached trials
Lower extremity mass4715.1
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 — unassessed100% consumernot reported in cached trials
Difficulty in walking26115.1
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 — unassessedserious n=82not reported in cached trials
Pelvic fracture57314.8
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 21.3NCT01343004: 1/820 (0.1%) control (serious AE)
Pubis fracture5314.7
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=53not reported in cached trials
Accidental needle stick6014.3
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
Hypercalciuria3514.2
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=20NCT01343004: 102/818 (12.5%) on Teriparatide; 74/820 (9.0%) control
Vascular injury10114.1
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 — unassessed100% consumernot reported in cached trials
Blood calcium abnormal11513.9
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 markerserious n=41 · 76% consumernot reported in cached trials
Pharmaceutical product complaint1,73913.2
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 — unassessedage-adj. PRR 23.3 · serious PRR 30.0not reported in cached trials
Spinal fracture1,28912.9
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% consumerNCT01343004: 2/818 (0.2%) on Teriparatide (serious AE)
Fractured sacrum7912.7
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=68not reported in cached trials
Thoracic vertebral fracture18112.2
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=144NCT01709110: 2/683 (0.3%) on Teriparatide (serious AE)
Wrist fracture72912.1
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% consumerNCT01343004: 2/818 (0.2%) on Teriparatide (serious AE)
Lumbar vertebral fracture27011.8
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=233NCT01343004: 1/818 (0.1%) on Teriparatide (serious AE)
Waist circumference increased6111.5
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 — unassessed100% consumernot reported in cached trials
Body height decreased62811.5
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 — unassessedserious n=196 · 88% consumernot reported in cached trials

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.

ConceptReportsPRR 95% CIReading
Fall / fracture9,7764.94.8–5.0signal
Tendon disorder2301.11.0–1.3no difference
Serious infection4,1791.01.0–1.0no difference
Stroke1,3041.00.9–1.0no difference
Arrhythmia / qt1,0051.00.9–1.0no difference
Depression1,3670.90.9–1.0lower than other drugs
Osteonecrosis2710.90.8–1.0lower than other drugs
Heart failure7970.80.8–0.9lower than other drugs
Hyponatraemia3560.80.7–0.9lower than other drugs
Opportunistic infection5960.80.8–0.9lower than other drugs
Myocardial infarction7980.70.7–0.8lower than other drugs
Anaemia1,1530.70.7–0.8lower than other drugs
Venous thromboembolism8110.70.7–0.7lower than other drugs
Malignancy1,2620.60.6–0.7lower than other drugs
Pancreatitis2500.60.5–0.7lower than other drugs
Hypoglycaemia2840.60.5–0.6lower 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).

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.

ReactionReportsPRR 95% CI · ROR · χ²/pEBGM EB05 · IC025Label screenSerious-only & strataTrial cross-check
Nausea9,0082.1
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% consumerNCT01343004: 42/818 (5.1%) on Teriparatide; 25/820 (3.0%) control
Arthralgia (joint pain)8,7054.0
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% consumerNCT01343004: 1/818 (0.1%) on Teriparatide; 1/820 (0.1%) control (serious AE)
Pain in extremity8,3665.4
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 — unassessedage-adj. PRR 4.8 · serious PRR 3.3 · 87% consumerNCT01343004: 42/818 (5.1%) on Teriparatide; 49/820 (6.0%) control
Dizziness8,3203.2
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% consumerNCT01343004: 2/818 (0.2%) on Teriparatide; 1/820 (0.1%) control (serious AE)
Fall7,9174.5
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 — unassessedage-adj. PRR 3.0 · serious PRR 5.6 · 73% consumerNCT01709110: 15/683 (2.2%) on Teriparatide (serious AE)
Pain7,5632.3
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% consumerNCT01343004: 1/822 (0.1%) on Teriparatide; 3/820 (0.4%) control (serious AE)
Muscle spasms5,7496.0
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% consumernot reported in cached trials
Malaise (feeling unwell)5,6852.4
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 — unassessedage-adj. PRR 2.2 · serious PRR 2.2 · 87% consumernot reported in cached trials
Headache5,5081.7
1.6–1.7ROR 1.7 · calibrated p 0.760
1.6 EB05 1.6 · IC025 +0.7Labeled adverse reaction
exact term
age-adj. PRR 2.0 · serious PRR 1.4 · 81% consumerNCT01343004: 1/822 (0.1%) on Teriparatide (serious AE)
Asthenia (weakness)5,4482.7
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% consumerNCT01709110: 1/683 (0.1%) on Teriparatide (serious AE)
Injection site pain (pain where injected)4,8333.0
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% consumerNCT01343004: 1/822 (0.1%) on Teriparatide; 3/820 (0.4%) control (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.

✓ 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

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.