What changed in 2025?
FDA removed the clozapine REMS program effective June 13, 2025. Pharmacies no longer need a registry blood result to fill it. FDA still recommends the ANC blood test schedule in the label.
What side effects need fast action?
Call the prescriber the same day for:
- Fever, sore throat, flu-like signs, or mouth sores (these can be signs of low white cells)
- Severe constipation, belly pain, or bloating
- Chest pain, a fast heartbeat, or trouble breathing
Call 911 for a seizure, fainting, or severe belly pain.
What can you do now?
Keep a blood test calendar.
What this step unlocks: problems caught early.
Tell the prescriber if your loved one starts or stops smoking.
What this step unlocks: smoking changes clozapine levels.
Call the prescriber if doses were missed, before anyone restarts the medicine.
What this step unlocks: a safer restart. Restarting at the old dose can be dangerous.
Store medication safely. Do not keep large amounts at home.
Ask about a clozapine clinic if the doctor says it is "too hard."
What this step unlocks: access when other medicines have not helped.
Don't. Don't hide medication in food or drinks.
Where can you find help in your state?
Illinois | Wisconsin | DC | Maryland | Virginia | California
This is general information, not legal or medical advice.
FAQ
Q: Does clozapine still need blood tests?
Yes. FDA removed the REMS registry in 2025 but still recommends ANC blood tests.
Q: Why is clozapine used?
It often helps schizophrenia that did not improve with other medicines, and it is approved for people at risk for recurrent suicidal behavior.
Q: What if doses were missed?
Call the prescriber before restarting. Restarting at the old dose can be dangerous.
Q: What side effects are urgent?
Fever, sore throat, severe constipation, chest pain, or a seizure.
