Fluoxetine (Sarafem) is an antidepressant used to treat premenstrual dysphoric disorder (PMDD). It's a selective serotonin reuptake inhibitor (SSRI) that contains the same active ingredient as fluoxetine (Prozac), which is used to treat other mental health conditions, including depression. Fluoxetine (Sarafem) is taken by mouth, either daily regularly or only for a couple of weeks during each menstrual cycle. Some common side effects include headache, weakness, and flu-like symptoms. Brand name Sarafem has been discontinued and fluoxetine (Sarafem) is only available as a lower-cost generic.
Fluoxetine (Sarafem) is part of an antidepressant class called selective serotonin reuptake inhibitors (SSRI), which blocks the absorption of a chemical called serotonin back into the brain. By balancing serotonin levels, fluoxetine (Sarafem) can help improve your mood.
Source:Â DailyMed
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Rare
cold sweats
confusion
convulsions (seizures)
cool pale skin
difficulty with concentration
drowsiness
dryness of the mouth
excessive hunger
fast or irregular heartbeat
headache
increased sweating
increased thirst
lack of energy
mood or behavior changes
overactive reflexes
purple or red spots on the skin
racing heartbeat
shakiness or unsteady walk
shivering or shaking
talking, feeling, and acting with excitement and activity you cannot control
trouble with breathing
unusual or incomplete body or facial movements
unusual tiredness or weakness
Incidence not known
Abdominal or stomach pain
agitation
back or leg pains
bleeding gums
blindness
blistering, peeling, or loosening of the skin
blood in the urine or stools
bloody, black or tarry stools
blue-yellow color blindness
blurred vision
chest pain or discomfort
clay-colored stools
continuing vomiting
dark urine
decreased urine output
decreased vision
difficulty with breathing
difficulty with swallowing
dizziness or lightheadedness
fainting
fast, pounding, or irregular heartbeat or pulse
general body swelling
high fever
hives, itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
hostility
indigestion
irregular or slow heart rate
irritability
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
light-colored stools
loss of appetite
loss of bladder control
muscle twitching
nightmares
no blood pressure or pulse
noisy breathing
nosebleeds
pain in the ankles or knees
painful, red lumps under the skin, mostly on the legs
pains in the stomach, side, or abdomen, possibly radiating to the back
pinpoint red spots on the skin
rapid weight gain
red or irritated eyes
red skin lesions, often with a purple center
redness, tenderness, itching, burning, or peeling of the skin
severe muscle stiffness
severe sleepiness
slurred speech
sores, ulcers, or white spots on the lips or in the mouth
stopping of heart
sudden shortness of breath or troubled breathing
sudden weakness in the arms or legs
sudden, severe chest pain
swelling of the face, ankles, or hands
swollen or painful glands
thoughts of killing oneself
tightness in the chest
tiredness
twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
unconsciousness
unpleasant breath odor
unusual bleeding or bruising
unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
unusually pale skin
use of extreme physical or emotional force
vomiting of blood
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Decreased appetite
Less common or rare
Abnormal dreams
breast enlargement or pain
change in sense of taste
changes in vision
feeling of warmth or heat
flushing or redness of the skin, especially on face and neck
increased appetite
increased sensitivity of the skin to sunlight
unusual secretion of milk, in females
yawning
Incidence not known
Cracks in the skin
loss of heat from the body
painful or prolonged erections of the penis
swelling of the breasts or breast soreness in both females and males
unusual milk production
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
If your prescriber changes your dose of fluoxetine (Sarafem), it can take several weeks before you notice an improvement in your symptoms. Just because you don't notice a change right away, it doesn't mean this medication isn't working. Talk with your HCP if you have any questions.
Let your prescriber know if you notice unusual or sudden changes in your mood, behavior, or thoughts, when you're taking fluoxetine (Sarafem). Though not common, taking an antidepressant might raise the risk of suicidal thoughts or behaviors, especially in people ages 24 years and younger.
Fluoxetine (Sarafem) might cause insomnia. If you experience trouble sleeping, ask your HCP if you can take this medication in the morning. In general, fluoxetine (Sarafem) is usually taken once daily, around the same time every day.
Fluoxetine (Sarafem) can cause dizziness and affect your thinking and movement, so don't drive or do anything that needs a lot of focus or attention until you know how this medication affects you.
Fluoxetine (Sarafem) can interact with many medications, including over-the-counter medications and supplements. Let your prescriber know your full medication history before starting this medication.
Fluoxetine (Sarafem) can cause your eyes to dilate (widen) and worsen angle-closure glaucoma. Let your HCP know if you have glaucoma before starting this medication. Also, let your prescriber know if you experience symptoms such as blurry vision, headache, or eye pain.
If you have diabetes, taking fluoxetine (Sarafem) might cause changes to your blood sugar levels. Your healthcare team might ask you to check your blood sugar level regularly while you're taking this medication. Let your prescriber know if your blood sugar level isn't under control or dropping lower than expected because they might need to change the dose of your medications.
Don't suddenly stop taking fluoxetine (Sarafem) without first speaking with your prescriber, especially if you've been taking it regularly for a long time. Doing so can cause withdrawal symptoms such as headache, dizziness, nausea, and vomiting. Your prescriber can help you stop fluoxetine (Sarafem) safely by lowering your dose slowly over time.
Fluoxetine (Sarafem) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Risk factors: People age 24 and younger | Mood problems
Studies suggest that taking antidepressants might raise the risk of suicidal thoughts and behavior. The risk seems to be higher for people ages 24 years and younger who already have depression or other mood problems.
Please let your family members or caregivers know of these risks so they can pay attention to any changes in your mood or behavior. Let your healthcare professional (HCP) know if your mood gets worse or if you have thoughts of wanting to hurt yourself because you might need to switch to another medication.
Risk factors: Taking medications that raise serotonin levels | Taking medications that prevent the breakdown of serotonin
Fluoxetine (Sarafem) can cause a life-threatening condition called serotonin syndrome, where high levels of a chemical called serotonin builds up in your body. The risk is higher when you take other medications that also raise serotonin levels, such as triptans, tricyclic antidepressants, lithium (Lithobid), or St. John's wort. Avoid taking fluoxetine (Sarafem) within 2 weeks of taking an MAO inhibitor, such as phenelzine (Nardil) or tranylcypromine (Parnate). Get emergency medical help if you experience symptoms like agitation, confusion, dizziness, or shakiness.
Fluoxetine (Sarafem) can cause serious, and sometimes life-threatening, allergic reactions and rashes. These side effects can go away once you stop taking fluoxetine (Sarafem) and get medical care. Let your HCP know right away if you experience any symptoms, such as rashes or hives, or if you also get other symptoms along with it, such as fever, joint pain, swelling, carpal tunnel syndrome, trouble breathing, or swelling.
Risk factors: Bipolar disorder
Sometimes, depression can be a sign of bipolar disorder. Although extremely rare, it's possible that taking an antidepressant alone can trigger a manic episode (great excitement, euphoria, delusions, and overactivity) in people who have bipolar disorder. Let your HCP know before starting fluoxetine (Sarafem) if you or someone in your family has bipolar disorder, and report any unusual changes in behavior.
Risk factors: Taking higher doses of fluoxetine (Sarafem)
Fluoxetine (Sarafem) can affect your appetite and cause both weight loss and weight gain. Let your HCP know if fluoxetine (Sarafem) is affecting your appetite and weight, and they can help you adjust your dose or change to a different medication.
Risk factors: Taking other medications that can cause bleeding
Fluoxetine (Sarafem) might raise the risk of bleeding, which can be life-threatening. Let your HCP know if you're taking other medications that might also cause bleeds, such as aspirin (Aspir-Low), NSAIDs, warfarin, or other blood thinners. See your HCP right away if you fall or hit your head so they can check for bleeding inside your body. Get medical help if you experience symptoms, such as dark stool, vomiting blood, bruises that don't go away, or nose bleeds that are hard to stop.
Risk factors: History of angle-closure glaucoma
Fluoxetine (Sarafem) can lead to or worsen angle-closure glaucoma. You might need to see your optometrist regularly and get eye exams to check your eyes and make sure your vision isn't worsening. Contact your optometrist or psychiatrist if you notice changes in your vision after starting fluoxetine (Sarafem).
Risk factors: Older adults | Taking water pills | Low body fluids
Fluoxetine (Sarafem) can cause very low sodium levels in your blood. This is usually the result of a condition called syndrome of inappropriate antidiuretic hormone secretion (SIADH), where the body has trouble getting rid of water. The risk is higher if you're older than 65 years old, taking diuretics (water pills), or don't have enough body fluids. This problem usually goes away when you stop taking fluoxetine (Sarafem), but it can be life-threatening if left untreated. Let your prescriber know if you get symptoms of headache, difficulty concentrating, memory problems, confusion, weakness, or unsteadiness.
Fluoxetine (Sarafem) can cause anxiety, nervousness, and insomnia (difficulty sleeping) in some people. Let your prescriber know if this is a problem for you, and they can let you know your options.
Fluoxetine (Sarafem) can lower sex drives. In females, this medication can delay orgasms or cause them not to have an orgasm at all. Let your prescriber know if this is a problem for you while taking fluoxetine (Sarafem).
Depending on your symptoms, your obstetrician-gynecologists (OB-GYN) or healthcare professional (HCP) will prescribe fluoxetine (Sarafem) for you to take in one of two ways:
Daily dosing: The typical dose is to take 20 mg by mouth once daily.
Dosing based on menstrual cycle: The typical dose is to take 20 mg by mouth once daily, starting 2 weeks before your period through the first full day of your period.
Your dose might differ if you have liver problems or other health conditions.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Taking monoamine oxidase inhibitors (MAOIs) with fluoxetine (Sarafem) or within 5 weeks of stopping fluoxetine (Sarafem)
Taking fluoxetine (Sarafem) within 14 days of stopping an MAOI
Taking pimozide with fluoxetine (Sarafem)
Taking thioridazine with fluoxetine (Sarafem)
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MedlinePlus. (2023). Syndrome of inappropriate antidiuretic hormone secretion.
National Institute of Mental Health. (2024). Bipolar disorder.
Pidgeon, T. S., et al. (2022). Carpal tunnel syndrome. OrthoInfo.
Steinberg, E. M., et al. (2012). Rapid response to fluoxetine in women with premenstrual dysphoric disorder. Depression and Anxiety.
Torrent Pharmaceuticals Limited. (2024). Fluoxetine tablet [package insert]. DailyMed.
U.S. Food and Drug Administration. (2018). Suicidality in children and adolescents being treated with antidepressant medications.
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