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The following safety information outlines potential risks and precautions when using this medication. It is important for patients and healthcare providers to review this information carefully and discuss any concerns.

• Unplanned Pregnancy and Birth Defects: While Synarel (nafarelin) is intended to block ovulation, there is still a risk of accidental pregnancy, especially if doses are missed. Be cautious of unplanned pregnancies as they may lead to birth defects. Regular monitoring and consultation with your healthcare provider are advised.

• Ovarian Cysts: Some individuals may develop ovarian cysts during the first two months of treatment, particularly those with polycystic ovarian syndrome (PCOS). Symptoms include pelvic pain, discomfort during intercourse, and bloating. These cysts typically resolve on their own within 4 to 6 weeks, but you should seek medical attention if symptoms persist or worsen.

• Bone Density Loss: Synarel (nafarelin) may reduce estrogen levels, potentially causing slight bone density loss. This risk is unknown after six months of use, and the medication should not be used for more than six months throughout your lifetime. Patients with a history of osteoporosis or those using medications that affect bone density should discuss their condition with their healthcare provider.

• Depression: New or worsening depression may occur with the use of Synarel (nafarelin). Patients with a history of depression should inform their provider to ensure appropriate mental health monitoring. Be alert for symptoms such as persistent sadness, difficulty concentrating, or sleep disturbances.

• Seizures: There is a risk of seizures, particularly in individuals with a history of seizures, stroke, or central nervous system tumors, as well as those taking medications like bupropion or sertraline. Inform your healthcare provider of any seizure history before starting treatment.

• Mood Changes: Children may experience mood alterations, including crying, irritability, and aggression. There is also a rare risk of depression with suicidal thoughts. If your child has a history of mental health issues, monitor them closely and consult their pediatrician if mood changes occur.

• High Blood Pressure in the Skull: Some children using Synarel (nafarelin) have experienced increased intracranial pressure. Watch for symptoms such as headaches, vision changes, and dizziness, and contact a healthcare provider if these occur.

Contraindications: Do not use Synarel (nafarelin) if you have abnormal vaginal bleeding, are currently pregnant or breastfeeding, or if you have allergies to GnRH agonists. Always consult your healthcare provider before starting this medication if you have any of these conditions.

In case of overdose, seek immediate medical attention.

When using this medication, some individuals may experience common side effects that are generally mild and manageable. These include hot flashes, which occur in a significant number of users, as well as a lower sex drive, vaginal dryness, and headaches. Mood swings and acne are also reported by some. If these symptoms persist or worsen, it is advisable to consult a healthcare provider for guidance.

Additionally, other side effects such as temporarily larger breast size, vaginal bleeding, mood swings, and a temporary increase in pubic hair growth have been noted, though they are less common. Some users may also experience a runny nose. While these symptoms are generally not severe, it's important to discuss them with a healthcare professional if they become bothersome.

There are rare but serious side effects that require immediate medical attention. These include nasal irritation, muscle pain, and changes in breast size. Serious side effects also encompass swelling in the hands or ankles, excessive sweating, unusual hair growth, and weight changes. Mental health symptoms such as depression, mood swings, or trouble sleeping should also be addressed urgently. In children, increased pressure around the brain is a significant concern, necessitating prompt medical intervention if symptoms like persistent nausea, severe headaches, or vision changes occur.

A very serious allergic reaction is rare but warrants immediate medical help if symptoms like rash, severe dizziness, or difficulty breathing appear. Always be vigilant about any changes in your health while on this medication and consult your healthcare provider for any concerns.

Synarel (nafarelin) can interact with various medications and supplements. It is crucial to inform your doctor and pharmacist about any other drugs or supplements you are using, including prescription, over-the-counter, vitamins, or herbal products. Some medications should not be combined with Synarel due to potential risks, and your doctor may choose an alternative treatment. These include Bepridil, Cisapride, Dronedarone, Mesoridazine, Pimozide, Piperaquine, Saquinavir, Sparfloxacin, Terfenadine, Thioridazine, and Ziprasidone.

In other cases, using Synarel with certain medicines might be necessary but requires careful consideration and possible adjustments by your doctor. This is because the combination could alter the effectiveness or increase the side effects of either medication. The comprehensive list of such drugs includes, but is not limited to, Alfuzosin, Amiodarone, Amisulpride, Amitriptyline, and many others. Always ensure healthcare providers are aware of all medications and supplements you are taking to manage these interactions safely.

Additionally, Synarel may affect specific laboratory tests, potentially leading to inaccurate results, especially those related to pituitary and gonadal functions. Inform all medical personnel involved in your care about your use of Synarel to avoid any misinterpretations of test outcomes.