Drug · FAERS side-effect profile with label screen
Alprostadil side effects: what 3,590 FDA adverse event reports show
Drug class
Prostaglandin Analog, Prostaglandin E1 Agonist
FDA label (Established Pharmacologic Class) · compare the class
Brand names
Caverject Impulse
openFDA label
Who reports
3,590 reports · 65% serious · 272 with death outcome · 15% female
openFDA FAERS counts, all years, deduplication not applied
Used for
CAVERJECT IMPULSE is a prostaglandin E1 agonist indicated • For the treatment of erectile dysfunction ( 1.1 ) • As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction ( 1.2 ). 1.1 Erectile Dysfunction CAVERJECT IMPULSE is indicated for the treatment of erectile dysfunction.
FDA label, Indications and Usage
What it is
CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E 1 (PGE 1 ) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid.
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 (related wording) 7Likely indication confounding 1Reporting / coding artifact 8Lab value / disease marker 8Not in label — unassessed 16
What the badges mean
- 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. 117 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 |
|---|---|---|---|---|---|---|
| Neutrophil count increased | 54 | 30.9 23.7–40.2ROR 31.3 · χ² 1,523 / p <1e-300 | 30.4 EB05 24.2 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 29.1 · 100% clinician | no trial data cached |
| Lymphocyte count decreased | 79 | 26.2 21.1–32.6ROR 26.8 · χ² 1,884 / p <1e-300 | 26.0 EB05 21.5 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 27.4 · 100% clinician | no trial data cached |
| Erectile dysfunction | 93 | 21.2 17.3–25.9ROR 21.7 · χ² 1,764 / p <1e-300 | 21.0 EB05 17.7 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.0 | no trial data cached |
| Blood urea increased | 59 | 20.5 15.9–26.5ROR 20.9 · χ² 1,075 / p 5e-236 | 20.4 EB05 16.4 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 19.6 · 100% clinician | no trial data cached |
| Haematotoxicity | 20 | 12.6 8.2–19.6ROR 12.7 · χ² 202 / p 3e-46 | 11.8 EB05 7.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · 90% clinician | no trial data cached |
| Device failure | 27 | 10.4 7.2–15.2ROR 10.5 · χ² 220 / p 4e-50 | 9.7 EB05 6.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Needle issue | 49 | 10.0 7.6–13.2ROR 10.2 · χ² 389 / p 7e-87 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=26 | no trial data cached |
| Disseminated intravascular coagulation | 21 | 8.7 5.7–13.3ROR 8.7 · χ² 135 / p 1e-31 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Arteriosclerosis | 14 | 8.7 5.1–14.7ROR 8.7 · χ² 88 / p 4e-21 | 7.3 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Generalised oedema | 18 | 8.6 5.4–13.6ROR 8.6 · χ² 113 / p 1e-26 | 7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 36 | 8.2 6.0–11.4ROR 8.3 · χ² 222 / p 2e-50 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.2 · 100% clinician | no trial data cached |
| Lung infection | 22 | 8.2 5.4–12.4ROR 8.2 · χ² 131 / p 1e-30 | 7.3 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 100% clinician | no trial data cached |
| Drug effect decreased | 73 | 7.8 6.2–9.8ROR 8.0 · χ² 428 / p 3e-95 | 7.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 75% consumer | no trial data cached |
| White blood cell count increased | 51 | 7.7 5.9–10.2ROR 7.8 · χ² 293 / p 5e-66 | 7.3 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 · ♀ 35% (drug 15%) · 96% clinician | no trial data cached |
| Syringe issue | 23 | 7.7 5.1–11.5ROR 7.7 · χ² 127 / p 1e-29 | 6.8 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious n=4 | no trial data cached |
| Caesarean section | 15 | 7.5 4.5–12.4ROR 7.5 · χ² 78 / p 7e-19 | 6.3 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.7 | no trial data cached |
| Hyperlipidaemia | 15 | 7.3 4.4–12.1ROR 7.3 · χ² 76 / p 2e-18 | 6.2 EB05 3.9 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Sexual dysfunction | 14 | 7.0 4.2–11.8ROR 7.0 · χ² 66 / p 2e-16 | 5.9 EB05 3.7 · IC025 +1.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 18 | 7.0 4.4–11.1ROR 7.0 · χ² 86 / p 8e-21 | 6.1 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Myocardial ischaemia | 13 | 6.6 3.9–11.4ROR 6.6 · χ² 57 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Injury associated with device | 22 | 6.4 4.2–9.7ROR 6.4 · χ² 95 / p 1e-22 | 5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious n=11 · 73% consumer | no trial data cached |
| Procedural pain | 29 | 6.1 4.3–8.8ROR 6.2 · χ² 120 / p 4e-28 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.3 | no trial data cached |
| Blood triglycerides increased | 17 | 5.6 3.5–9.0ROR 5.6 · χ² 60 / p 5e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| Cardiac failure (heart failure) | 73 | 5.3 4.2–6.7ROR 5.4 · χ² 252 / p 5e-57 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · ♀ 40% (drug 15%) | no trial data cached |
| C-reactive protein increased | 33 | 5.3 3.8–7.5ROR 5.3 · χ² 111 / p 3e-26 | 5.0 EB05 3.7 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.7 · 100% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 21 | 4.9 3.2–7.6ROR 5.0 · χ² 62 / p 2e-15 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 5.0 | no trial data cached |
| Device malfunction | 55 | 4.8 3.7–6.2ROR 4.8 · χ² 161 / p 3e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Wrong technique in drug usage process | 30 | 4.8 3.3–6.8ROR 4.8 · χ² 85 / p 1e-20 | 4.5 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.0 | no trial data cached |
| Haemoglobin decreased | 83 | 4.7 3.8–5.8ROR 4.8 · χ² 240 / p 2e-54 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 99% clinician | no trial data cached |
| Drug effect incomplete | 29 | 4.6 3.2–6.6ROR 4.6 · χ² 78 / p 4e-19 | 4.3 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · 97% consumer | no trial data cached |
| Device mechanical issue | 10 | 4.5 2.4–8.4ROR 4.5 · χ² 24 / p 5e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Product prescribing error | 18 | 4.4 2.8–7.0ROR 4.5 · χ² 45 / p 1e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Hepatic function abnormal | 28 | 4.4 3.1–6.4ROR 4.4 · χ² 71 / p 2e-17 | 4.1 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 · ♀ 54% (drug 15%) · 96% clinician | no trial data cached |
| Pulmonary congestion | 10 | 4.4 2.4–8.2ROR 4.4 · χ² 23 / p 8e-7 | 3.7 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Multiple organ dysfunction syndrome | 21 | 4.4 2.9–6.7ROR 4.4 · χ² 52 / p 3e-13 | 4.0 EB05 2.8 · IC025 +1.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.9 · 95% clinician | no trial data cached |
| Hypokalaemia (low potassium) | 34 | 4.3 3.1–6.1ROR 4.4 · χ² 84 / p 3e-20 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 50% (drug 15%) · 97% clinician | no trial data cached |
| Ischaemic stroke | 13 | 4.3 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Coagulopathy | 12 | 4.2 2.4–7.4ROR 4.2 · χ² 26 / p 1e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Prostatic specific antigen increased | 10 | 4.2 2.3–7.8ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Lab value / disease marker | serious PRR 5.5 | no trial data cached |
| Drug effect less than expected | 10 | 4.1 2.2–7.7ROR 4.2 · χ² 21 / p 2e-6 | 3.6 EB05 2.1 · IC025 +0.8 3/3 methods agree | Reporting / coding artifact | – | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 883 | 3.9 3.7–4.2ROR 4.9 · χ² 2,046 / p <1e-300 | 3.9 EB05 3.7 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 | no trial data cached |
| Erectile dysfunction | 93 | 21.2 17.3–25.9ROR 21.7 · χ² 1,764 / p <1e-300 | 21.0 EB05 17.7 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 14.0 | no trial data cached |
| Injection site pain (pain where injected) | 92 | 1.8 1.4–2.2ROR 1.8 · χ² 31 / p 2e-8 | 1.8 EB05 1.5 · IC025 +0.5 | Labeled (related wording) related wording | serious PRR 2.8 · 72% consumer | no trial data cached |
| Product quality issue | 92 | 4.0 3.3–4.9ROR 4.1 · χ² 204 / p 1e-46 | 3.9 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Haemoglobin decreased | 83 | 4.7 3.8–5.8ROR 4.8 · χ² 240 / p 2e-54 | 4.6 EB05 3.8 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · 99% clinician | no trial data cached |
| Lymphocyte count decreased | 79 | 26.2 21.1–32.6ROR 26.8 · χ² 1,884 / p <1e-300 | 26.0 EB05 21.5 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 27.4 · 100% clinician | no trial data cached |
| Cardiac failure (heart failure) | 73 | 5.3 4.2–6.7ROR 5.4 · χ² 252 / p 5e-57 | 5.1 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 · ♀ 40% (drug 15%) | no trial data cached |
| Drug effect decreased | 73 | 7.8 6.2–9.8ROR 8.0 · χ² 428 / p 3e-95 | 7.5 EB05 6.2 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 · 75% consumer | no trial data cached |
| Blood glucose increased | 65 | 2.0 1.6–2.6ROR 2.0 · χ² 32 / p 7e-9 | 2.0 EB05 1.6 · IC025 +0.6 | Lab value / disease marker | serious PRR 4.2 | no trial data cached |
| Blood urea increased | 59 | 20.5 15.9–26.5ROR 20.9 · χ² 1,075 / p 5e-236 | 20.4 EB05 16.4 · IC025 +3.7 3/3 methods agree | Lab value / disease marker | serious PRR 19.6 · 100% clinician | no trial data cached |
| Device malfunction | 55 | 4.8 3.7–6.2ROR 4.8 · χ² 161 / p 3e-37 | 4.6 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 | no trial data cached |
| Neutrophil count increased | 54 | 30.9 23.7–40.2ROR 31.3 · χ² 1,523 / p <1e-300 | 30.4 EB05 24.2 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 29.1 · 100% clinician | no trial data cached |
| White blood cell count increased | 51 | 7.7 5.9–10.2ROR 7.8 · χ² 293 / p 5e-66 | 7.3 EB05 5.8 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.7 · ♀ 35% (drug 15%) · 96% clinician | no trial data cached |
| Incorrect dose administered | 50 | 1.3 1.0–1.7ROR 1.3 · χ² 3 / p 0.037 | 1.3 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.5 | no trial data cached |
| Needle issue | 49 | 10.0 7.6–13.2ROR 10.2 · χ² 389 / p 7e-87 | 9.6 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious n=26 | 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.
- Haematotoxicity — n=20, PRR 12.6
- Disseminated intravascular coagulation — n=21, PRR 8.7
- Drug reaction with eosinophilia and systemic symptoms — n=36, PRR 8.2
- Lung infection — n=22, PRR 8.2
- Syringe issue — n=23, PRR 7.7
- Hepatic function abnormal — n=28, PRR 4.4
- Hypokalaemia — n=34, PRR 4.3
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 Alprostadil?
In FDA FAERS, the most frequently co-reported reaction terms for Alprostadil are erectile dysfunction, injection site pain, haemoglobin decreased, lymphocyte count decreased, cardiac failure, blood glucose increased. 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 Alprostadil have an FDA boxed warning?
No. The FDA label retrieved for Alprostadil has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Alprostadil 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 4dec1dbd-c63b-4a1b-81cb-c8d29696cc40, effective 20240229; matched on
openfda.generic_name.exact:"ALPROSTADIL") - 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, 157 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.