Forfivo XL Warnings and Precautions

• Seizures or epilepsy
• Liver problems, including liver failure or cirrhosis
• Kidney disease, including kidney failure (renal failure)
• A brain tumor
• A history of head trauma or brain injury
• Diabetes
• An eating disorder, such as bulimia or anorexia
• Bipolar disorder or a family history of bipolar disorder (also known as manic depression)
• Heart disease
• Had a recent heart attack
• A history of suicide attempts or suicidal thoughts
• Any allergies, including to foods, dyes, or preservatives.

• Pregnant or thinking of becoming pregnant
• Breastfeeding.

• Forfivo XL can increase the risk for seizures (see Forfivo XL Seizures). Because of this, there are certain people who should not take this drug, including people with:

• Seizure disorders
• Bulimia or anorexia
• Brain trauma or brain injury
• Severe liver cirrhosis.

Also, people taking certain medications have a higher risk for seizures (see Forfivo XL Drug Interactions). Abruptly stopping alcohol or sedative medications can also increase your chance of this complication.

• Antidepressants, including Forfivo XL, may increase the risk for suicidal thoughts or behavior in children, teenagers, and adults (see Depression and Suicide for more information). Therefore, if you notice any changes in symptoms or new symptoms, talk to your healthcare provider immediately (see Antidepressants and Suicide for more information).

Some of these symptoms may include:

• Anxiety
• Hostility
• Agitation
• Panic
• Restlessness
• Hallucinations
• Extreme hyperactivity
• Suicidal thoughts or behavior.

• Before prescribing Forfivo XL for depression, your healthcare provider should make sure you do not have bipolar disorder. Sometimes, the symptoms of bipolar disorder and depression are quite similar, and Forfivo XL can cause problems in people with bipolar disorder.

• Forfivo XL should not be used right after a heart attack. Also, there is some evidence that this antidepressant can cause irregular heart rhythms (arrhythmias) in people with heart disease.

• This drug can cause liver damage. Also, because the liver and kidneys help to remove Forfivo XL from the blood, you should talk to your healthcare provider before taking this antidepressant if you have liver or kidney problems.

• This medication can cause mental problems, especially in people who are just starting treatment with it. Tell your healthcare provider if you are experiencing any of signs of these problems, such as:

• Insomnia
• Agitation
• Hallucinations
• Confusion.

• Forfivo XL can cause weight loss. This can be a problem for some people, especially those who are underweight (see Forfivo XL and Weight Loss for more information).

• Forfivo XL can cause allergic reactions. Tell your healthcare provider if you have signs of an allergic reaction, such as:

• An unexplained skin rash
• Itching
• Hives
• Trouble breathing
• Unexplained swelling.

• Sometimes, this drug can cause high blood pressure (hypertension), especially in people using nicotine patches. Your healthcare provider should monitor your blood pressure if you are taking Forfivo XL. It is unknown whether it would cause problems in people who have heart disease or who have recently had a heart attack.

• Forfivo XL is a pregnancy Category C medication. This means that it may not be safe to take during pregnancy. Talk to your healthcare provider about the risks and benefits of using this antidepressant while pregnant (see Forfivo XL and Pregnancy for more information).

• Forfivo XL passes through breast milk. Therefore, if you are breastfeeding or plan to start, talk with your healthcare provider before using this medication (see Forfivo XL and Breastfeeding).