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Safety evidence center

Explore adverse-event reports, controlled safety studies and evidence gaps. Case reports identify possible signals, not incidence or proven causation. No reported harm does not establish safety.

Body-system filters are text-based discovery aids, not clinical diagnoses. Regulatory warnings and prescribing guidance require separate, current source review.

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69 matching summaries

How this library is organized

Studies default to publication date, newest first, not the date a summary was added. Choose Most relevant for human-first editorial reading order, not an effectiveness or quality ranking. Design, topic and intervention-candidate labels assist discovery; they are not formal appraisals. Result-direction and sample-size filters only use existing verified metadata; missing values are excluded when those filters are active. Study counts are publications, not unique trials or participants.

Evidence & review standardsSafety center

69 results · Page 1 of 6

Human · Randomized trial · 2026-10-26

Efficacy and Safety of Lonapegsomatropin in Children With Turner Syndrome: 52-Week Results From the New InsiGHTS Trial.

A randomized phase 2 trial compared weekly lonapegsomatropin with daily somatropin for growth in Turner syndrome.

Population, studied exposure & key finding
Population
49 prepubertal children were enrolled and dosed, according to the publication.
Studied dose & duration
Weekly subcutaneous lonapegsomatropin starting doses: 0.24, 0.30 or 0.36 mg hGH/kg/week. Daily somatropin totaled 0.35 mg/kg/week, not per day; 52 weeks.
Finding
Primary week-26 annualized height velocity was 9.23–10.36 cm/year across weekly starting-dose groups versus 10.86 with daily treatment. Secondary week-52 rates were 9.05 pooled versus 9.04 cm/year. The abstract reported similar tolerability.

Abstract summarized · Verified intervention · Summary quality not appraised

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Animal · Cell / tissue · Preclinical · 2026-10-23

Mots-c attenuates diabetic nephropathy by downregulating LARS1 to promote lipophagy and suppress tubular senescence.

Preclinical experiments tested whether MOTS-c protects against diabetic kidney injury through lipid-droplet clearance.

Population, studied exposure & key finding
Population
Diabetic db/db mice and HK-2 kidney cells. This was not an administered-human trial.
Studied dose & duration
MOTS-c treatment with LARS1-overexpression and autophagy-inhibition experiments. Dose, route, frequency, duration and sample sizes were unavailable in the abstract.
Finding
Urinary albumin/creatinine and tissue-injury findings improved alongside reduced lipid accumulation and senescence markers. LARS1 overexpression blocked protective cell effects; an autophagy inhibitor largely reversed protection in mice.

Abstract summarized · Verified intervention · Summary quality not appraised

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Animal · Cell / tissue · Preclinical · 2026-10-10

Mitochondrial-derived peptide MOTS-c rescues vascular endothelial damage via PLA2G6 in diabetic retinopathy

Preclinical experiments examined whether MOTS-c protects retinal blood vessels during diabetic injury.

Population, studied exposure & key finding
Population
Human retinal endothelial cells exposed to high glucose and a streptozotocin-induced diabetic mouse model. No administered-human study.
Studied dose & duration
MOTS-c treatment with genetic pathway experiments; dose, route, duration and sample sizes were not reported in the abstract.
Finding
Endothelial barrier and mitochondrial measures improved. PLA2G6 increased, and its knockdown blocked protection, supporting a role for phospholipid regulation and lipid-peroxide handling.

Abstract summarized · Verified intervention · Summary quality not appraised

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Human · Unclassified · 2026-10-09

Long-term Safety and Efficacy of Once-Weekly Lonapegsomatropin in Adults With Growth Hormone Deficiency: Results From a 52-Week Open-Label Extension Trial.

An open-label extension followed weekly growth-hormone replacement.

Population, studied exposure & key finding
Population
220 adults with GH deficiency who completed the parent trial.
Studied dose & duration
Weekly lonapegsomatropin for a 52-week extension after the 38-week parent trial. All received active treatment; exact doses were not in the abstract.
Finding
Body-composition improvements were maintained or improved relative to parent-trial baseline through up to 90 weeks. Injection-site reactions occurred in 5.1%, mild or moderate. Respiratory infections and headache were common events.

Abstract summarized · Verified intervention · Summary quality not appraised

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Human · Sponsor announcement · Unclassified · 2026-10-07

Zealand Pharma announces positive Phase 2 ZUPREME-2 topline results for amylin analog petrelintide in people with overweight or obesity and type 2 diabetes

Preliminary ZUPREME-2 results tested an amylin analog against placebo.

Population, studied exposure & key finding
Population
220 adults with overweight/obesity and type 2 diabetes.
Studied dose & duration
Weekly subcutaneous petrelintide, with escalation, versus placebo for 28 weeks. Milligram targets were not disclosed.
Finding
Sponsor-reported weight loss was 7.4–9.2% versus 2.0%, using the efficacy estimand. Placebo-adjusted HbA1c reduction was 0.61–0.88 percentage points. GI-related discontinuation: 1.9% versus 1.7%.

Sponsor announcement summarized · Verified intervention · Summary quality not appraised

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Human · Randomized trial · 2026-09-30

Cardiovascular safety of orforglipron versus insulin glargine in adults with type 2 diabetes at increased cardiovascular risk (ACHIEVE-4): a phase 3, event-driven, randomised, open-label, non-inferiority, active comparator trial.

ACHIEVE-4 compared cardiovascular safety of oral orforglipron and insulin glargine.

Population, studied exposure & key finding
Population
2749 adults with diabetes, overweight/obesity and established cardiovascular or kidney disease.
Studied dose & duration
Daily oral orforglipron up to 36 mg capsule-equivalent (17.2 mg tablet), versus daily titrated injectable insulin glargine; median follow-up two years.
Finding
Major cardiovascular events: 4.2% versus 5.0%; HR 0.84 (95% CI 0.59–1.20). Noninferiority was met, not superiority. GI events: 62.1% versus 14.2%; significant/severe hypoglycemia: 6.8% versus 19.2%.

Abstract summarized · Verified intervention · Summary quality not appraised

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Review · Systematic review · 2026-09-18

Menopause hormone therapy and type 2 diabetes risk and prognosis: systematic review and meta-analyses

A systematic review assessed menopause hormone therapy and glucose metabolism.

Population, studied exposure & key finding
Population
49 articles, including randomized trials and cohorts, reported 1,472,277 participants in or after the menopause transition.
Studied dose & duration
Estrogen alone, combined hormone therapy or tibolone versus placebo or no therapy. Doses and routes varied; there was no single pooled regimen.
Finding
Fasting insulin and insulin resistance were modestly lower. New diabetes risk ratio was 0.83 (95% CI 0.75 to 0.92), with very-low-certainty evidence. In women with diabetes, HbA1c was lower by 0.50 percentage points, also very-low-certainty evidence.

Full paper summarized · Verified intervention · Summary quality not appraised

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Human · Unclassified · 2026-09-13

Intermittent enzalutamide in recurrent prostate cancer: testosterone kinetics and related toxicity.

Whether testosterone changes tracked breast enlargement during intermittent enzalutamide treatment for recurrent prostate cancer.

Population, studied exposure & key finding
Population
38 patients with recurrent prostate cancer received intermittent 3-month enzalutamide courses without androgen-deprivation treatment. Testosterone and adverse events were monitored prospectively.
Studied dose & duration
Not extracted or not reported in the reviewed source.
Finding
Median peak testosterone was 832.5 ng/dL. Breast-enlargement symptoms occurred in 42% of patients. Neither peak testosterone nor time with elevated testosterone correlated with these symptoms, and symptoms during one course did not reliably predict the next.

Abstract summarized · Mention / other research · Summary quality not appraised

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Animal · Preclinical · 2026-09-12

Amphora Coffeaeformis Extract as a Novel Therapeutic Agent against Gamma Radiation-Induced Infertility in Male Rats.

Whether an Amphora coffeaeformis algal extract improved reproductive injury after gamma radiation.

Population, studied exposure & key finding
Population
Male Wistar rats given whole-body gamma radiation followed by oral extract for 21 days, compared with irradiated and nonirradiated controls. The abstract does not give group sizes.
Studied dose & duration
In this male Wistar rat experiment, animals first received a single whole-body gamma-radiation exposure of 3.5 Gy, then were treated with Amphora coffeaeformis algal extract by mouth at 772 mg per kg of body weight daily for 21 consecutive days. Radiation-only rats were described as a comparison. These are animal-study exposures, not human doses.
Finding
Compared with radiation alone, extract treatment improved testicular weight, tissue appearance and semen measurements. Sperm motility recovered from 0.00 percent to 70.66 percent, and testosterone rose from 0.67 to 2.43 ng/mL.

Abstract summarized · Mention / other research · Summary quality not appraised

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Review · Systematic review · 2026-09-12

Testosterone monitoring and supplementation in patients with intermediate- or high-risk prostate cancer treated with 6-36 months of androgen deprivation therapy and radiotherapy: a systematic literature review.

A systematic review of testosterone monitoring, recovery and replacement after androgen-deprivation therapy plus radiotherapy for prostate cancer.

Population, studied exposure & key finding
Population
Twenty-nine studies concerning intermediate- or high-risk localized prostate cancer. Searches ran through May 2026; total participant numbers are not given in the abstract.
Studied dose & duration
Not extracted or not reported in the reviewed source.
Finding
Baseline testosterone predicted recovery rather than cancer outcomes. Lower testosterone during treatment was associated with better cancer outcomes. Recovery varied, often taking years to normalize, with longer treatment, older age and lower starting testosterone associated with slower recovery.

Abstract summarized · Mention / other research · Summary quality not appraised

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Case report · Case report · 2026-09-11

Oxymetholone-Associated Cholestatic Drug-Induced Liver Injury With Profound Hyperbilirubinaemia: A Longitudinal Case Report.

Full-paper case report followed suspected cholestatic liver injury after 29 days of self-administered oral oxymetholone 50 mg/day plus intramuscular testosterone enanthate 250 mg/week.

Population, studied exposure & key finding
Population
One previously healthy 26-year-old male gym instructor presented with jaundice, dark urine, pale stools and severe itching.
Studied dose & duration
The case report describes self-administered oral oxymetholone 50 mg/day with intramuscular testosterone enanthate 250 mg/week. Presentation was on day 29; both agents were withdrawn on day 30. Product identity was not chemically verified.
Finding
Peak bilirubin was 24.6 mg/dL with cholestatic injury; synthetic and renal function remained preserved. After both agents stopped, bilirubin fell 91.5% by day 85.

Full paper summarized · Intervention candidate · Summary quality not appraised

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Human · Preprint · Observational · 2026-09-11

Anti-Müllerian Hormone and Metabolic Dysfunction in Polycystic Ovary Syndrome: A Cross-Sectional Study with Age-Stratified Analysis and BMI Mediation

Whether anti-Müllerian hormone adds information about metabolic risk in polycystic ovary syndrome.

Population, studied exposure & key finding
Population
A single-center cross-sectional study of 123 women with polycystic ovary syndrome, including 43 adolescents and 80 reproductive-aged women.
Studied dose & duration
Not extracted or not reported in the reviewed source.
Finding
Higher hormone levels correlated with lower body mass index and LDL cholesterol, but higher testosterone. Its association with insulin resistance weakened after adjusting for body mass index. A model adding hormones and age did not clearly outperform body mass index alone.

Abstract summarized · Mention / other research · Summary quality not appraised

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