Overall Safety Profile
Based on clinical trials (mainly in India, plus preclinical studies in the US and Australia), RISUG and its variants (Vasalgel/ADAM) show an excellent safety profile with very low rates of serious side effects. It is non-hormonal, acts locally, and does not affect sexual function, hormones, or libido. Studies involving more than 300 men confirm ~97–100% efficacy for 10–15 years after a single bilateral injection (120 µl of polymer gel into the vas deferens).
Reported Side Effects
- Mild and Transient (1–4 weeks post-injection): Mild scrotal pain (17–20%), scrotal swelling (10–15%), small nodules at injection site (5–10%). All resolve spontaneously — similar to or milder than a no-scalpel vasectomy.
- Serious Side Effects: None reported. No erectile dysfunction, chronic infections, sperm granulomas, or toxicity.
Detailed Data by Users and Injections
- Phase I/II (India, 1993–2002): ~20–64 healthy men. One injection per vas (2 total). 82–100% azoospermia in 1–6 months. Follow-up up to 10+ years; zero unplanned pregnancies after success.
- Limited Phase III (India, 2000–2023): 139–303 men. Single bilateral injection. 97.3% contraceptive success; no significant adverse events at 6 months.
- Preclinical (USA/Australia): Monkeys & rabbits. 99% efficacy, fully reversible, zero serious side effects. Human Phase I/II trials ongoing (2023–2025).
Conclusion
RISUG is one of the most promising long-acting, reversible, non-hormonal male contraceptives currently in development, with a safety profile superior to vasectomy. Approval in India expected 2025–2026.
Always consult a urologist for personalized medical advice.
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