Tagrisso and Fertility: What Should I Know?
Written by Dr. Olivia Bennett, Senior Oncology & Clinical Research Content Specialist
Reviewed for medical accuracy under the Ivermectinkart Editorial Policy
Introduction
If you take Tagrisso and hope to have children now or in the future, it is reasonable to ask how Tagrisso and fertility may be connected. Tagrisso (osimertinib) is a targeted cancer medicine used for certain EGFR-mutated non-small cell lung cancers, and current product information says its effects on human fertility are not known. However, animal studies found effects on male and female reproductive organs and suggest that fertility could potentially be impaired. Tagrisso can also harm a developing fetus, making pregnancy prevention during treatment particularly important. These findings do not tell us exactly what will happen to an individual person's fertility or whether any effect will be permanent.
Understanding that uncertainty before treatment can help patients have informed conversations about fertility preservation, contraception, pregnancy planning, and their cancer care.
Can Tagrisso Affect Fertility?
Possibly, but we do not have human data that establish how often Tagrisso affects fertility, how severely it does so, or whether an effect would be permanent. Current product information specifically states that there are no data on Tagrisso's effects on human fertility.
Tagrisso contains osimertinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor. The fertility concern comes mainly from animal studies rather than studies measuring fertility outcomes in people taking the medicine.
The current Tagrisso Summary of Product Characteristics reports effects on male and female reproductive organs in animals and states that osimertinib could impair fertility.
That distinction is essential: animal reproductive toxicity is a safety signal, but it cannot tell us precisely how an individual person's fertility will respond.
Tagrisso should not be described as proven to cause infertility in humans. The available evidence shows reproductive effects in animals, while direct human fertility data are lacking.
What Do Studies Tell Us About Tagrisso and Male Fertility?
Animal studies raise a potential concern about male fertility, but they do not establish that men taking Tagrisso will become infertile.
What happened in animal studies?
In repeat-dose studies, degenerative changes occurred in the testes of rats and dogs exposed to osimertinib for at least one month. Male fertility was reduced in rats after three months of exposure.
Importantly, these findings occurred at clinically relevant drug exposures.
There is some evidence of recovery, but the picture is incomplete. Testicular changes observed after one month of treatment were reversible in rats. According to the UK product information, however, a definitive conclusion about reversibility could not be made for the findings in dogs.
Animal findings cannot establish whether the same changes occur in human sperm production or fertility.
Does Tagrisso lower sperm count?
There are insufficient human data to say that Tagrisso causes a particular reduction in sperm count, sperm movement, or other semen parameters.
This is why someone who wants biological children should not wait for fertility difficulties to occur before raising the subject. When circumstances allow, fertility concerns are best discussed with the oncology team and a fertility specialist before treatment begins.
What is currently known about Tagrisso and fertility
Question | What the evidence shows | What remains uncertain |
Does Tagrisso affect male fertility? | Animal studies found testicular changes and reduced fertility in male rats | Effect and frequency in humans |
Does Tagrisso affect female fertility? | Animal studies found changes involving ovaries and the female reproductive tract | Effect and frequency in humans |
Are fertility effects permanent? | Some animal findings showed reversibility | Whether human fertility changes occur or are reversible |
Can pregnancy occur during treatment? | Pregnancy is possible, so effective contraception is required | Individual fertility cannot be predicted |
Can Tagrisso affect pregnancy? | Animal evidence and its mechanism indicate potential fetal harm | Human pregnancy data remain limited |
Should fertility be discussed before treatment? | Fertility risk is uncertain but biologically plausible | Individual options depend on cancer treatment needs and circumstances |
What Do We Know About Tagrisso and Female Fertility?
Animal studies also suggest that osimertinib may affect female fertility. Again, this has not been quantified in women taking Tagrisso.
What did female animal studies find?
Animal studies reported changes including degeneration of structures within the ovaries called corpora lutea, as well as thinning of tissues in the uterus and vagina. Some ovarian findings after one month of treatment showed evidence of reversibility.
In a female fertility study in rats, osimertinib did not affect the estrous cycle or the number of animals becoming pregnant at the studied dose, but early embryonic deaths occurred. The UK product information reports evidence of reversibility after a one-month period without treatment.
These results should not be translated into a predicted infertility rate for women. Human reproductive biology and treatment circumstances differ, and appropriate clinical fertility data are lacking.
Does Tagrisso cause early menopause?
Current product information does not establish that Tagrisso causes premature menopause in humans.
Changes seen in animal ovaries provide a reason for caution, but they cannot be used to conclude that a woman taking Tagrisso will experience premature ovarian insufficiency or menopause.
For someone concerned about future pregnancy, the practical issue is therefore uncertainty, not a guaranteed loss of fertility.
Should I Consider Fertility Preservation Before Tagrisso?
If having biological children in the future matters to you, discussing fertility preservation before treatment starts, when medically feasible, can be valuable. The appropriate options depend on sex, age, reproductive health, cancer status, treatment plan, and how quickly cancer treatment needs to begin.
Options for women
Depending on the circumstances, fertility-preservation discussions may include freezing eggs or embryos. Other approaches may be relevant in particular situations.
These procedures require specialist assessment and sometimes take time. Cancer treatment should not be postponed independently while arranging fertility preservation.
Your oncologist and fertility specialist can determine whether there is a medically acceptable opportunity to pursue preservation without compromising the timing of cancer treatment.
Options for men
Sperm cryopreservation—collecting and freezing semen for possible future use—is an established fertility-preservation approach for men receiving potentially fertility-affecting cancer treatment.
When possible, the discussion is most useful before therapy because it establishes options before potential treatment-related reproductive effects occur.
For people who have already started Tagrisso, it is not necessarily too late to discuss fertility. A reproductive specialist can advise what evaluation or preservation approaches remain reasonable in the individual circumstances.
Can You Get Pregnant While Taking Tagrisso?
Pregnancy should be avoided during Tagrisso treatment because osimertinib may harm a developing fetus. Animal studies found reproductive toxicity including embryonic death, reduced fetal growth, and neonatal death.
This pregnancy risk is separate from fertility. A medicine can potentially affect fertility while pregnancy remains possible.
Contraception for women taking Tagrisso
Current UK product information advises women who can become pregnant to use effective contraception during treatment and for at least 2 months after completing Tagrisso.
Tagrisso may also reduce exposure to hormonal contraceptives, so relying on an oral hormonal contraceptive deserves specific discussion with the treating team.
Contraception for men taking Tagrisso
Men are advised to use effective contraception during treatment when pregnancy could occur and continue it for at least 4 months after completing treatment, according to current UK product information.
The Tagrisso patient information leaflet also explains contraception considerations for both women and men receiving treatment.
Pregnancy and fertility dos and don'ts during Tagrisso treatment
Do | Don't |
Discuss future fertility before treatment when possible | Assume animal findings mean infertility is inevitable |
Tell your oncologist if having biological children matters to you | Delay cancer treatment independently to pursue fertility preservation |
Ask about fertility preservation when appropriate | Assume fertility preservation is impossible once treatment has begun |
Use effective contraception as directed during treatment | Assume reduced fertility means pregnancy cannot occur |
Discuss hormonal contraception with your treatment team | Change contraception without professional guidance |
Tell your oncology team immediately about a pregnancy during treatment | Stop Tagrisso independently if pregnancy occurs |
What If I Want a Baby After Finishing Tagrisso?
Planning a pregnancy after Tagrisso requires individualized advice because several questions need to be considered: whether cancer treatment has finished, whether fertility has been affected, how long contraception needs to continue, and whether stopping treatment is medically appropriate.
Do not use the end of treatment as an automatic signal that it is safe to try for pregnancy.
Current UK prescribing information specifies contraception for at least 2 months after the final dose for women and 4 months for men. These are contraception recommendations related to medication exposure; they do not guarantee that fertility has returned to a person's pretreatment level.
If fertility is a concern after treatment, a specialist may discuss appropriate reproductive evaluation. What that involves depends on the person—for example, semen assessment in men or evaluation of ovarian and reproductive health in women.
What If Pregnancy Happens During Tagrisso Treatment?
Contact the treating oncology team promptly if you or your partner becomes pregnant during Tagrisso treatment. Do not stop or change cancer treatment without discussing the situation with the oncology team.
There are limited human pregnancy data, so clinicians rely substantially on the drug's mechanism and animal reproductive studies when assessing risk. Current product information states that osimertinib may cause fetal harm and generally should not be used during pregnancy unless the woman's clinical condition requires treatment.
The decision can be complex because both fetal exposure and the consequences of interrupting effective cancer treatment need careful consideration. It requires individualized discussion among the patient, oncology team, and appropriate pregnancy specialists.
Breastfeeding also requires caution. Current product information advises discontinuing breastfeeding during Tagrisso treatment because a risk to the nursing child cannot be excluded.
Conclusion
The most important point about Tagrisso and fertility is that uncertainty remains. There are no adequate human data establishing how Tagrisso affects fertility, but animal studies found changes in male and female reproductive organs and reduced male fertility, so a potential effect cannot be dismissed.
Pregnancy also needs to be avoided during treatment because osimertinib may harm a developing fetus.
If future biological children matter to you, raise fertility preservation and pregnancy planning with your oncology team as early as possible. Never delay, interrupt, or stop Tagrisso independently. Fertility decisions during cancer treatment should be individualized with your oncologist and, when appropriate, a reproductive specialist.
Frequently Asked Questions
1 . Can Tagrisso make you infertile?
It is not known whether Tagrisso causes infertility in humans. Animal studies found reproductive-organ changes and reduced fertility in male rats, while female reproductive effects were also observed. These findings indicate a potential risk but cannot predict an individual's fertility.
2 . Can Tagrisso affect sperm?
Human studies have not established how Tagrisso affects sperm count, movement, or quality. Animal studies found degenerative testicular changes and reduced male fertility in rats after osimertinib exposure. Men concerned about future fatherhood should discuss fertility preservation with their treatment team.
3 . Can Tagrisso affect a woman's fertility?
Possibly, although the effect in humans remains unknown. Animal studies found changes involving the ovaries and other reproductive tissues, and some findings showed evidence of reversibility. These results cannot establish whether women taking Tagrisso will experience fertility problems.
4 . Can I freeze my eggs or sperm before taking Tagrisso?
Fertility preservation may be possible depending on your circumstances and how urgently cancer treatment needs to begin. Options can include egg, embryo, or sperm freezing. Discuss this promptly with your oncology team and a fertility specialist rather than delaying Tagrisso independently.
5 . How long after Tagrisso can I try for a baby?
Current UK product information advises effective contraception for at least 2 months after treatment for women and 4 months for men. These intervals do not answer every fertility question, so pregnancy plans should also be discussed with the treating oncology team.
6 . What happens if I become pregnant while taking Tagrisso?
Contact your oncology team promptly because Tagrisso may harm a developing fetus. Animal studies found reproductive toxicity, while human pregnancy data are limited. Do not stop Tagrisso on your own; the risks of fetal exposure and changing cancer treatment require individualized medical assessment.
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