Drug · FAERS side-effect profile with label screen
Testosterone Cypionate side effects: what 8,875 FDA adverse event reports show
Drug class
Androgen
FDA label, Indications wording
Brand names
Azmiro
openFDA label
Who reports
8,875 reports · 57% serious · 386 with death outcome · 6% female
openFDA FAERS counts, all years, deduplication not applied
Used for
AZMIRO is indicated for testosterone replacement therapy in males in conditions associated with a deficiency or absence of endogenous testosterone: • Primary hypogonadism (congenital or acquired): testicular failure due to conditions such as cryptorchi.
FDA label, Indications and Usage
What it is
AZMIRO (testosterone cypionate) injection for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air.
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 4Labeled (related wording) 8Likely indication confounding 6Reporting / coding artifact 6Lab value / disease marker 4Not in label — unassessed 12
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 974 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 |
|---|---|---|---|---|---|---|
| Product gel formation | 35 | 970.5 654.6–1,438.9ROR 974.4 · χ² 23,249 / p <1e-300 | 497.9 EB05 374.2 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Coronary bypass thrombosis | 13 | 890.6 470.2–1,687.0ROR 891.9 · χ² 7,725 / p <1e-300 | 330.6 EB05 205.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Product deposit | 319 | 620.7 549.6–701.1ROR 643.8 · χ² 155,370 / p <1e-300 | 476.3 EB05 434.0 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Product with quality issue administered | 56 | 424.9 319.8–564.5ROR 427.6 · χ² 19,671 / p <1e-300 | 320.1 EB05 255.7 · IC025 +6.0 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Metaplasia | 34 | 182.5 128.8–258.5ROR 183.2 · χ² 5,524 / p <1e-300 | 154.7 EB05 115.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=34 · ♀ 100% (drug 6%) · 100% clinician | no trial data cached |
| Polycythaemia | 79 | 95.1 76.0–119.0ROR 95.9 · χ² 6,977 / p <1e-300 | 89.5 EB05 74.1 · IC025 +5.5 3/3 methods agree | Labeled adverse reaction exact term | serious n=71 | no trial data cached |
| Suspected product tampering | 19 | 85.9 54.4–135.8ROR 86.1 · χ² 1,457 / p <1e-300 | 76.7 EB05 51.9 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Liquid product physical issue | 244 | 84.5 74.5–95.8ROR 86.8 · χ² 19,348 / p <1e-300 | 81.1 EB05 72.9 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Secondary hypogonadism | 11 | 81.9 44.9–149.3ROR 82.0 · χ² 772 / p 3e-170 | 69.9 EB05 41.7 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=10 | no trial data cached |
| Blood testosterone increased | 70 | 79.2 62.5–100.4ROR 79.8 · χ² 5,152 / p <1e-300 | 75.1 EB05 61.5 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=28 | no trial data cached |
| Product closure issue | 15 | 66.8 40.0–111.6ROR 66.9 · χ² 882 / p 3e-194 | 60.2 EB05 38.8 · IC025 +3.5 3/3 methods agree | Reporting / coding artifact | – | no trial data cached |
| Ischaemia | 127 | 66.6 55.9–79.4ROR 67.6 · χ² 7,921 / p <1e-300 | 64.2 EB05 55.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=127 | no trial data cached |
| Poor quality product administered | 243 | 57.5 50.7–65.2ROR 59.1 · χ² 13,114 / p <1e-300 | 55.9 EB05 50.2 · IC025 +5.4 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Idiopathic intracranial hypertension | 47 | 50.4 37.8–67.3ROR 50.7 · χ² 2,181 / p <1e-300 | 48.5 EB05 37.9 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=47 · 100% clinician | no trial data cached |
| Blood testosterone abnormal | 23 | 49.6 32.8–74.9ROR 49.7 · χ² 1,025 / p 3e-225 | 46.8 EB05 32.9 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | no trial data cached |
| Multiple use of single-use product | 113 | 49.0 40.7–59.0ROR 49.6 · χ² 5,157 / p <1e-300 | 47.6 EB05 40.7 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | – | no trial data cached |
| Infarction | 133 | 46.3 39.1–55.0ROR 47.0 · χ² 5,744 / p <1e-300 | 45.2 EB05 39.1 · IC025 +5.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.8 | no trial data cached |
| Blood testosterone decreased | 124 | 43.2 36.2–51.5ROR 43.8 · χ² 4,974 / p <1e-300 | 42.1 EB05 36.3 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=35 | no trial data cached |
| Blood oestrogen increased | 10 | 41.4 22.2–77.4ROR 41.5 · χ² 349 / p 3e-78 | 38.0 EB05 22.0 · IC025 +2.7 3/3 methods agree | Lab value / disease marker | serious n=3 | no trial data cached |
| Haematocrit increased | 39 | 41.0 29.9–56.2ROR 41.2 · χ² 1,457 / p <1e-300 | 39.6 EB05 30.2 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Hypogonadism | 16 | 37.7 23.0–61.7ROR 37.7 · χ² 527 / p 7e-117 | 35.7 EB05 23.3 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=13 | no trial data cached |
| Polycythaemia vera | 12 | 35.4 20.0–62.5ROR 35.4 · χ² 362 / p 6e-81 | 33.2 EB05 20.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Testicular atrophy | 10 | 27.4 14.7–51.2ROR 27.5 · χ² 226 / p 2e-51 | 25.8 EB05 14.7 · IC025 +2.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=5 | no trial data cached |
| Suspected product contamination | 11 | 27.4 15.1–49.7ROR 27.5 · χ² 251 / p 6e-57 | 25.9 EB05 15.3 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=10 | no trial data cached |
| Cardiac ventricular thrombosis | 14 | 26.4 15.6–44.8ROR 26.5 · χ² 314 / p 1e-70 | 25.3 EB05 15.9 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Product contamination physical | 25 | 24.0 16.2–35.6ROR 24.1 · χ² 524 / p 3e-116 | 23.4 EB05 16.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious n=5 · 72% consumer | no trial data cached |
| Quality of life decreased | 129 | 22.9 19.3–27.2ROR 23.2 · χ² 2,654 / p <1e-300 | 22.6 EB05 19.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 622 | 22.7 21.0–24.5ROR 24.3 · χ² 12,794 / p <1e-300 | 22.5 EB05 21.0 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.7 | no trial data cached |
| Product tampering | 17 | 22.6 14.0–36.4ROR 22.6 · χ² 326 / p 4e-73 | 21.8 EB05 14.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Cardiovascular disorder | 225 | 20.9 18.4–23.8ROR 21.5 · χ² 4,221 / p <1e-300 | 20.7 EB05 18.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.3 | no trial data cached |
| Poor quality drug administered | 57 | 20.7 15.9–26.8ROR 20.8 · χ² 1,038 / p 4e-228 | 20.4 EB05 16.3 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=6 | no trial data cached |
| Thrombophlebitis superficial | 24 | 18.5 12.4–27.7ROR 18.6 · χ² 378 / p 2e-84 | 18.1 EB05 12.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Acute myocardial infarction | 228 | 18.3 16.1–20.8ROR 18.8 · χ² 3,692 / p <1e-300 | 18.2 EB05 16.3 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.3 | no trial data cached |
| Pre-existing condition improved | 48 | 18.1 13.6–24.0ROR 18.2 · χ² 752 / p 6e-166 | 17.8 EB05 13.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Coronary artery thrombosis | 15 | 17.6 10.6–29.3ROR 17.6 · χ² 217 / p 2e-49 | 16.8 EB05 10.3 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Physical disability | 31 | 16.5 11.6–23.5ROR 16.6 · χ² 434 / p 1e-96 | 16.2 EB05 11.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=30 | no trial data cached |
| Prostatic disorder | 38 | 16.3 11.9–22.5ROR 16.4 · χ² 528 / p 4e-117 | 16.0 EB05 12.1 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=38 · ♀ 75% (drug 6%) · 91% clinician | no trial data cached |
| Red blood cell count increased | 19 | 16.3 10.4–25.6ROR 16.3 · χ² 256 / p 7e-58 | 15.7 EB05 10.2 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=10 | no trial data cached |
| Recalled product administered | 60 | 16.2 12.6–20.9ROR 16.3 · χ² 835 / p 8e-184 | 16.0 EB05 12.8 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | 80% consumer | no trial data cached |
| Haemoglobin increased | 30 | 15.8 11.1–22.7ROR 15.9 · χ² 399 / p 4e-89 | 15.4 EB05 11.2 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=11 | 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 |
|---|---|---|---|---|---|---|
| Myocardial infarction (heart attack) | 949 | 12.8 12.1–13.6ROR 14.2 · χ² 10,350 / p <1e-300 | 12.7 EB05 12.1 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.9 | no trial data cached |
| Cerebrovascular accident (stroke) | 684 | 9.5 8.9–10.2ROR 10.2 · χ² 5,237 / p <1e-300 | 9.5 EB05 8.9 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.6 | no trial data cached |
| Deep vein thrombosis (leg blood clot) | 622 | 22.7 21.0–24.5ROR 24.3 · χ² 12,794 / p <1e-300 | 22.5 EB05 21.0 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 22.7 | no trial data cached |
| Drug ineffective (drug did not work) | 612 | 1.1 1.0–1.2ROR 1.1 · χ² 6 / p 0.009 | 1.1 EB05 1.0 · IC025 +0.0 | Reporting / coding artifact | serious PRR 0.7 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 558 | 13.9 12.8–15.0ROR 14.7 · χ² 6,646 / p <1e-300 | 13.8 EB05 12.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.9 | no trial data cached |
| Pain | 485 | 1.9 1.7–2.0ROR 1.9 · χ² 198 / p 2e-45 | 1.9 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Fatigue (tiredness) | 478 | 1.5 1.3–1.6ROR 1.5 · χ² 70 / p 4e-17 | 1.5 EB05 1.3 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Product dose omission issue | 392 | 3.3 3.0–3.6ROR 3.4 · χ² 617 / p 1e-136 | 3.2 EB05 3.0 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | no trial data cached |
| Anxiety | 364 | 3.0 2.7–3.3ROR 3.1 · χ² 494 / p 8e-110 | 3.0 EB05 2.8 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Thrombosis | 345 | 10.1 9.1–11.2ROR 10.5 · χ² 2,831 / p <1e-300 | 10.0 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.4 | no trial data cached |
| Product deposit | 319 | 620.7 549.6–701.1ROR 643.8 · χ² 155,370 / p <1e-300 | 476.3 EB05 434.0 · IC025 +7.9 3/3 methods agree | Reporting / coding artifact | serious n=15 | no trial data cached |
| Off label use (used outside approved label) | 312 | 0.8 0.8–0.9ROR 0.8 · χ² 9 / p 0.002 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 0.8 | no trial data cached |
| Injection site pain (pain where injected) | 309 | 2.4 2.2–2.7ROR 2.5 · χ² 256 / p 7e-58 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.4 | no trial data cached |
| Asthenia (weakness) | 267 | 1.7 1.5–1.9ROR 1.7 · χ² 74 / p 5e-18 | 1.7 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.5 | no trial data cached |
| Dyspnoea (shortness of breath) | 253 | 1.1 0.9–1.2ROR 1.1 · χ² 1 / p 0.197 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled (related wording) related wording | serious PRR 1.1 | 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.
- Metaplasia — n=34, PRR 182.5
- Liquid product physical issue — n=244, PRR 84.5
- Ischaemia — n=127, PRR 66.6
- Idiopathic intracranial hypertension — n=47, PRR 50.4
- Quality of life decreased — n=129, PRR 22.9
- Poor quality drug administered — n=57, PRR 20.7
- Thrombophlebitis superficial — n=24, PRR 18.5
- Pre-existing condition improved — n=48, PRR 18.1
- Physical disability — n=31, PRR 16.5
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 Testosterone Cypionate?
In FDA FAERS, the most frequently co-reported reaction terms for Testosterone Cypionate are myocardial infarction, cerebrovascular accident, deep vein thrombosis, pulmonary embolism, pain, fatigue. 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 Testosterone Cypionate have an FDA boxed warning?
No. The FDA label retrieved for Testosterone Cypionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Testosterone Cypionate 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 235b5625-570d-3fba-e063-6394a90aa2d1, effective 20250725; matched on
openfda.generic_name.exact:"TESTOSTERONE CYPIONATE") - 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, 1,014 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.