Based on NIH | Can omeprazole cause erectile dysfunction, and how common is this side effect?

Omeprazole can be associated with erectile dysfunction, but it appears to be uncommon. Several official U.S. product labels list erectile dysfunction among postmarketing urogenital adverse reactions reported with omeprazole, alongside findings like interstitial nephritis and testicular pain. ^{[1] [2]} Because these are spontaneously reported events without clear denominators, the exact frequency is not established and is likely rare. ^{[1] [2]}

What official labeling says

• Multiple FDA‑listed omeprazole products include erectile dysfunction in the urogenital adverse reaction section, grouped with events identified after marketing. ^{[1] [3]} These labels also note kidney‑related effects (e.g., interstitial nephritis) and urinary abnormalities, indicating that sexual side effects have been reported but are not among the most frequent reactions like headache or diarrhea. ^{[1] [3]}
• Similar wording appears across different omeprazole formulations, reinforcing that erectile dysfunction has been observed in postmarketing experience. ^{[4] [2]}
• Esomeprazole, a closely related proton pump inhibitor, also lists erectile dysfunction among postmarketing adverse reactions, suggesting a possible class effect signal rather than a finding unique to one brand. ^[5]

How common is it?

• The labels include erectile dysfunction as a postmarketing reaction, which means cases were reported, but they do not provide a quantified rate such as “common,” “uncommon,” or “rare.” ^{[1] [2]} In pharmacovigilance terms, this usually implies the frequency is unknown and likely low compared with common PPI side effects (e.g., headache, diarrhea) that are quantified in trials. ^{[1] [3]}
• Large safety reviews of proton pump inhibitors emphasize other risks (like enteric infections or bone fracture associations) and do not identify erectile dysfunction as a consistent or prominent risk with a measurable excess in randomized trials, which suggests any association with ED is, at most, uncommon. ^{[6] [7]}

Possible explanations and context

• Postmarketing reports can reflect coincidental events or confounding factors (age, diabetes, hypertension, smoking, cardiovascular disease, and polypharmacy), all of which are well‑known contributors to erectile dysfunction. ^[8]
• Limited mechanistic data do not show a consistent effect of PPIs on male hormones in humans; for example, standard‑dose lansoprazole did not alter luteinizing hormone or testosterone in a controlled crossover trial of young men. ^[9] While this is a different PPI, it suggests a direct endocrine mechanism is not established at therapeutic doses. ^[9]
• Because erectile dysfunction is common in the general population and increases with the number of medications taken, individual cases during PPI use can be multifactorial rather than directly caused by omeprazole. ^[8]

What to do if you notice symptoms

• It may be reasonable to review all medications and medical conditions first, since many non‑PPI factors commonly drive erectile dysfunction. Discussing the timing of symptoms relative to starting omeprazole can help assess plausibility.
• If omeprazole is suspected, clinicians sometimes consider a monitored dose reduction, a time‑limited discontinuation trial, or switching to an alternative therapy when appropriate for the underlying condition, while watching for symptom changes. Any change should be guided by your clinician to avoid reflux relapse or drug interactions.
• If erectile dysfunction persists, evaluation for common causes (metabolic and cardiovascular risk factors, hormonal testing when indicated) is generally recommended, along with consideration of standard treatments.

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Summary table: What we know

Topic	Evidence from official labeling	Estimated frequency	Notes
Omeprazole and erectile dysfunction	Listed as a postmarketing urogenital adverse reaction	Not quantified (frequency unknown)	Appears across multiple omeprazole labels; suggests uncommon signal. [1] [2] [3] [4]
Class consistency (PPIs)	Similar listing for esomeprazole	Not quantified	Points to a possible class signal, still unquantified. [5]
Trial and review data	Major PPI safety reviews do not highlight ED as a consistent, measurable risk	Likely rare/uncommon if present	More prominent quantified risks relate to infections and fractures. [6] [7]
Mechanism in humans	Small crossover study with lansoprazole showed no change in LH/testosterone	No direct endocrine effect shown at standard doses	Human endocrine impact not demonstrated; animal findings are species‑specific. [9]

In short, erectile dysfunction has been reported with omeprazole in postmarketing experience, but the true rate is unknown and appears to be low; most available data do not show a clear, common causal effect. ^{[1] [2] [6] [7]}