Worst Pills, Best Pills

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Drug Profile

The information on this site is intended to supplement and enhance, not replace, the advice of a physician who is familiar with your medical history. Decisions about your health should always be made ONLY after detailed conversation with your doctor.

Limited Use [what does this mean?]
Generic drug name: citalopram (si TAL oh pram)
Brand name(s): CELEXA
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: escitalopram (ess si TAL oh pram)
Brand name(s): LEXAPRO
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: fluoxetine (floo OX a teen)
Brand name(s): PROZAC, SARAFEM, SYMBYAX
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: fluvoxamine (floo VOX a meen)
Brand name(s): LUVOX
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: paroxetine (pa ROX uh teen)
Brand name(s): PAXIL, PAXIL CR, PEXEVA
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Limited Use [what does this mean?]
Generic drug name: sertraline (SER tra leen)
Brand name(s): ZOLOFT
GENERIC: available FAMILY: Selective Serotonin Reuptake Inhibitors (SSRIs)
Find the drug label by searching at DailyMed.

Pregnancy and Breast-feeding Warnings [top]

Pregnancy Warning

These drugs caused harm to developing fetuses in animal studies, including decreased growth and survival and malformations of heart and bones. There was, also, an increase in pup deaths and delays in growth. There is new evidence that when women take these drugs in the third trimester of pregnancy, serious complications can arise in their infants’ health immediately after delivery. These complications require prolonged hospitalization, respiratory support, and tube feeding.

Breast-feeding Warning

Because selective serotonin reuptake inhibitors are excreted in human milk and have been shown to have adverse effects in nursing infants, you should not nurse while taking these drugs.

Safety Warnings For This Drug [top]

FDA BLACK BOX WARNING

SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behaviors in pediatric and young adult patients in short-term studies. All antidepressant-treated patients should be closely monitored for clinical worsening, and for emergence of suicidal thoughts and behaviors.

Citalopram and paroxetine are not approved for use in pediatric patients.

Escitalopram is not approved for use in pediatric patients younger than age 12.

Fluoxetine is not approved for use in pediatric patients younger than age 7.

Fluvoxamine and sertraline are not approved for use in pediatric patients except for patients with obsessive-compulsive disorder.

Interaction With MAO (Monoamine Oxidase) Inhibitors

Do not take citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, or sertraline with monoamine oxidase (MAO) inhibitors (see Interactions with Other Drugs) because the combinations may produce a syndrome of rising temperature, tremor, and seizures.

Sexual Dysfunction

All of the SSRI antidepressants have been shown to commonly cause sexual dysfunction in both men and women. In a large prospective study of over 6,000 men and women, sexual dysfunction occurred 36–43% of the time, depending on the drug. Types of sexual dysfunction include problems of desire (libido: sexual interest or drive), arousal (erectile function in men, lubrication in women) and release (ejaculation/orgasm in men and orgasm in women). Strategies to cope with this problem include decreasing the dosage to the lowest effective level; a drug holiday for patients in whom compliance is not a problem; if acceptable to the patient and partner, seeing if the sexual dysfunction resolves without further intervention.[1]

Withdrawal Reactions With Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants

A withdrawal reaction has been reported with all SSRI antidepressants: citalopram (CELEXA); escitalopram (LEXAPRO), fluoxetine (PROZAC, SARAFEM); fluvoxamine (LUVOX); paroxetine (PAXIL); and sertraline (ZOLOFT). The symptoms generally start within one to three days after stopping the drug and generally resolve within one to two weeks after the drug has been discontinued. Withdrawal symptoms may occur even when the dosage of the drug is gradually decreased. The main symptoms of this reaction are irritability, agitation, anxiety, insomnia, dizziness, vertigo, lack of coordination, nausea and vomiting, and flulike symptoms that include fatigue, lethargy, muscle pain, and chills.

Facts About This Drug [top]

The drugs in this profile are selective serotonin reuptake inhibitors (SSRIs). Except for fluvoxamine (LUVOX), they are all approved by the Food and Drug Administration (FDA) for major depressive disorder (MDD). Various SSRIs also are approved to treat other psychiatric disorders: obsessive-compulsive disorder, bulimia, panic disorder, social anxiety disorder and post-traumatic stress disorder. Although SSRIs may reduce the risk of suicide in depressed adult patients, particularly adults over...

The drugs in this profile are selective serotonin reuptake inhibitors (SSRIs). Except for fluvoxamine (LUVOX), they are all approved by the Food and Drug Administration (FDA) for major depressive disorder (MDD). Various SSRIs also are approved to treat other psychiatric disorders: obsessive-compulsive disorder, bulimia, panic disorder, social anxiety disorder and post-traumatic stress disorder. Although SSRIs may reduce the risk of suicide in depressed adult patients, particularly adults over age 65, there is evidence that fluoxetine (PROZAC, SARAFEM, SYMBYAX) and other antidepressants may actually increase suicide risk in children, teenagers and young adults aged 18 to 24.[2],[3] Only fluoxetine is approved for MDD in children. Fluoxetine, fluvoxamine and sertraline (ZOLOFT) are approved in children and adolescents for the treatment of obsessive-compulsive disorder.[4]

For patients who need an antidepressant drug, we recommend trying one of these SSRIs first, as these are the safest antidepressants. If symptoms do not improve sufficiently with use of an SSRI and remain severe, further treatment with other antidepressants is warranted.

Do not use paroxetine (BRISDELLE) for hot flashes

BRISDELLE contains a low dose (7.5 milligrams [mg]) of the SSRI paroxetine, the same active ingredient contained in PAXIL and PEXEVA. This low-dose version of paroxetine is FDA-approved for treatment of hot flashes associated with menopause.

In March 2013, Public Citizen's Health Research Group testified before an FDA advisory committee to warn about paroxetine's questionable benefits in women with hot flashes associated with menopause as well as the drug's previously well-established risks.[5] Also, some patients who took paroxetine to treat hot flashes in clinical trials and who had no history of prior mental illness developed suicidal thoughts and mood changes after starting the drug.[5] The advisory committee subsequently opposed approval of Brisdelle, but the FDA ultimately rejected this recommendation and, in June 2013, approved yet another drug with risks that clearly outweigh its benefits.

Other drugs containing paroxetine remain designated as Limited Use for treatment of depression and other psychiatric disorders.

Most depression can be treated without drugs

The time it takes an antidepressant to work can overlap with the time of spontaneous recovery — recovery that might occur without the use of medications — especially if the depression is situational (that is, if it is caused by a death or other external circumstances). Most people recover from depression with the help of friends, spiritual resources or activities such as exercise, work, reading, play, art interests and travel. If these measures do not work for you, try seeking help from mental health professionals, such as therapists or psychiatrists. Antidepressant drugs should be reserved for situations in which a patient suffering from major depression does not respond to psychotherapy alone.

 

Don't Accidentally Double Your Dose

Prozac also is sold as Sarafem to treat a condition known as premenstrual dysphoric disorder. Women taking Prozac should not take Sarafem because they are the same drug.

 

Adverse effects

The most frequently reported adverse effects of SSRI antidepressants are nausea, anxiety, headache, sexual dysfunction and insomnia. These adverse effects, except for sexual dysfunction, tend to be worst at the start of treatment and improve over a few weeks. Akathisia — a condition characterized by symptoms of restlessness, constant pacing and purposeless movements of the feet and legs — also may occur. Dry mouth, sweating, diarrhea, tremor, loss of appetite and dizziness are also common adverse effects.

Serotonin syndrome

A potential danger when taking SSRIs or selective serotonin/norepinephrine reuptake inhibitors (SNRIs; for example, venlafaxine [EFFEXOR XR]) in combination with migraine headache drugs called triptans is serotonin syndrome. Serotonin syndrome is a potentially life-threatening adverse drug reaction that happens when there is an excess of serotonin, a naturally occurring nerve transmitter in the brain. Excess serotonin is usually the result of taking two or more drugs that have an effect on serotonin — such as SSRIs. (Read more in the April 2008 Worst Pills, Best Pills News.)

The symptoms of serotonin syndrome include the following:

  • Restlessness
  • Hallucinations
  • Loss of coordination
  • Fast heartbeat
  • Increased body temperature
  • Rapid changes in blood pressure
  • Overactive reflexes
  • Diarrhea
  • Coma
  • Nausea
  • Vomiting[6]

Neuroleptic malignant syndrome

In 2009, the FDA updated the product label of antidepressants to warn of the occurrence of neuroleptic malignant syndrome (NMS) resulting from the use of SSRIs and SNRIs alone or with subsequent use of serotonergic drugs (such as triptans), drugs that decrease the metabolism of serotonin, or antipsychotics or other dopamine antagonists.[7]

Symptoms and signs of NMS can include hyperthermia (extremely high body temperature); heavy sweating; fast heart rate; fast respiratory rate; rapidly fluctuating blood pressure; impaired consciousness; tremor; and rigid, stiff muscles. (Read more in the December 2010 Worst Pills, Best Pills News.)

Abnormal bleeding

The product labels for SSRIs and SNRIs include a precaution that these drugs may increase the risk of bleeding. Combined use of SSRIs or SNRIs and aspirin, nonsteroidal anti-inflammatory drugs, warfarin (COUMADIN, JANTOVEN) or other anticoagulants may increase this risk. (Read more in the March 2012 Worst Pills, Best Pills News.)

A study published in 2009 in the Clinical Gastroenterology and Hepatology journal found that current, recent (last used within 90 days) and past (last used more than 90 days ago) users of SSRIs were at an increased risk of serious gastrointestinal bleeding compared with those who did not use SSRIs.[8] (Read more in the April 2010 Worst Pills, Best Pills News.)

Further, research published in 2011 in the Canadian Medical Association Journal found that patients prescribed an SSRI antidepressant (such as fluoxetine or paroxetine) in addition to aspirin or with aspirin plus clopidogrel (PLAVIX) after a heart attack were at a significantly increased risk of bleeding compared with patients who were prescribed aspirin, clopidogrel or both.[9]

Low blood sodium

SSRIs and SNRIs also have been associated with cases of clinically significant hyponatremia (low blood sodium). Elderly patients may be at greatest risk of this condition.

Symptoms of hyponatremia include the following:

  • Headache
  • Difficulty concentrating
  • Memory impairment
  • Confusion
  • Weakness
  • Unsteadiness, which may lead to falls

Symptoms associated with more severe or acute cases of hyponatremia have included the following:

  • Hallucination
  • Syncope (fainting)
  • Seizure
  • Coma
  • Respiratory arrest
  • Death[10]

QT prolongation

In August 2011, the FDA issued an advisory that citalopram (CELEXA), when used at a dosage of 40 mg a day, could cause abnormal changes in the electrical activity of the heart. The agency advised against using citalopram at a dosage greater than 40 mg per day. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram) can lead to an abnormal heart rhythm (including torsades de pointes), which can be fatal. The advisory also stated that studies did not show a benefit in the treatment of depression with dosages greater than 40 mg per day.[11]

In December 2011, the Medicines and Healthcare products Regulatory Agency (MHRA) in the U.K. also issued a warning on QT prolongation associated with the dose of citalopram and escitalopram (LEXAPRO). The MHRA warning included the following recommendation:

For citalopram, new restrictions on the maximum daily doses now apply: 40 mg for adults, 20 mg for patients older than 65 years and 20 mg for those with hepatic impairment. For escitalopram, the maximum daily dose for patients older than 65 years is now reduced to 10 mg/day; other doses remain unchanged.[12]

In 2011 in Australia[13] and 2012 in Canada, similar regulatory advisories were issued on the dose-dependent QT prolongation associated with citalopram and on the recommended dosing changes.

In July 2013, the FDA issued an advisory that the agency received reports of QT interval prolongation and life-threatening abnormal heart rhythms, including torsades de pointes, in patients treated with fluoxetine.[14]

In 2016, Prescrire International published an article reporting that citalopram and escitalopram were associated with more cardiac adverse effects than other SSRI drugs.[15]

Sperm abnormalities

In 2015, Prescrire International published an article summarizing data from three studies showing that men taking SSRI drugs had decreased sperm counts and other changes in sperm that may affect fertility.[16]

Antidepressants and pregnancy

On Aug. 9, 2004, Health Canada, a regulatory body similar to the FDA, issued a public advisory warning to Canadians that newborns may be adversely affected when their mothers take SSRIs and other newer antidepressants during the third trimester of pregnancy. Health Canada reported that some newborns whose mothers took these drugs during pregnancy have developed complications at birth requiring prolonged hospitalization, breathing support and tube feeding. The symptoms reported include feeding and breathing difficulties, seizures, muscle rigidity, jitteriness and constant crying. In most cases, the mothers took a newer antidepressant during the third trimester of pregnancy.[17]

The labeling for paroxetine includes findings from an epidemiological study suggesting that exposure to the drug in the first trimester of pregnancy may be associated with an increased risk of cardiac birth defects.[18]

An article published in Prescrire International in February 2011 presented information from the European Medicines Agency indicating that fluoxetine and other SSRIs may cause cardiac birth defects during pregnancy. The agency had reported in 2010 that there was an increase in the risk of cardiac malformations in newborns whose mothers used fluoxetine during the first trimester of pregnancy. The authors of the article stated:

In practice, all [SSRIs] should be considered to carry a potential risk of congenital cardiac malformations. This is yet another reason to carefully weigh the potential benefits and risks of prescribing SSRIs to pregnant women or to women who may become pregnant.

In July 2006, the FDA notified health care professionals and consumers that there may be additional, though rare, risks associated with taking SSRI medications during pregnancy. This FDA notification cited a study focused on newborn babies with persistent pulmonary hypertension of the newborn (PPHN), a serious and life-threatening lung condition that occurs soon after birth.[19] Babies with PPHN have high pressure in the blood vessels in their lungs and are not able to get enough oxygen into their bloodstream. However, the agency backtracked on this warning in another announcement issued in December 2011. In the new announcement, the FDA stated that since the 2006 study, additional studies have presented conflicting information, meaning a link between SSRI use and PPHN could not be confirmed.[13]

In 2015, the American Journal of Obstetrics and Gynecology published an article warning that infants born to mothers who used sertraline during the first trimester of pregnancy had an increased risk of cardiac birth defects and an increased risk of craniosynostosis (a skull birth defect that prevents the brain from growing normally). The study also showed that skull and muscle defects were associated with exposure to other drugs in the SSRI drug group.[20]

In 2016, the British Journal of Clinical Pharmacology published a meta-analysis of data from 23 studies showing that paroxetine use during the first trimester of pregnancy was associated with an increased risk of major birth defects of the heart.[21]

In 2020, JAMA Psychiatry published an article showing that SSRI drug use during early pregnancy may be associated with a small increased risk of birth defects.[22]

Comparing SSRIs with older tricyclic antidepressants

Multiple meta-analyses of available data on SSRIs have failed to show superior effectiveness compared with tricyclic antidepressants, an older class of drugs approved for the same purpose. In fact, when the results of 64 randomized, controlled trials were pooled, researchers found no clear benefit for the newer SSRI drugs over older antidepressants.

The adverse effects of new and old antidepressants are different, except for withdrawal symptoms, which are common to both groups. SSRIs are less likely than tricyclic drugs to have anticholinergic effects (for example, double or blurry vision, constipation, urinary retention, decreased sweating and hyperthermia) or to cause sedation and heart rhythm disturbances. On the other hand, SSRIs commonly affect the gastrointestinal tract, especially causing nausea and diarrhea, and also may cause sexual dysfunction, insomnia, agitation, drug-induced Parkinsonism and withdrawal effects.

Patients are simply trading off one group of adverse effects for another when deciding between SSRIs and tricyclic antidepressants.[23] In terms of adverse effects, large-scale meta-analyses combining data from multiple clinical trials found that patients taking SSRIs were just as likely to discontinue the drugs as those taking tricyclic antidepressants.[24] (Drug discontinuation rates can be used to compare adverse reactions between drugs.)

Do not use antidepressants to treat dementia

In 2011, the medical journal Lancet published an article on the results of a study conducted to evaluate the effects of sertraline and mirtazapine (REMERON) on depression in patients with dementia. Randomized, multicenter, double-blind and placebo-controlled, the study demonstrated that in depressed patients with dementia, use of these antidepressant drugs did not show a benefit over the use of a placebo.[25] Based on the adverse effects of these medications and their lack of benefit for this use, antidepressants should not be used to treat dementia.

Do not use antidepressants to prevent depression following a stroke.

In 2021, Journal of the American Medical Association Neurology published a study showing that fluoxetine use after a stroke did not prevent the symptoms of depression. The study also showed that using fluoxetine after a stroke increases the risk of bone fractures.[26]

Other regulatory actions surrounding SSRIs

1991: Public Citizen's Health Research Group petitioned the FDA to require a warning in the product label for fluoxetine. The proposed warning would inform doctors that a small minority of persons taking the drug have experienced intense, violent or suicidal thoughts; agitation; and impulsivity after starting treatment with the drug.

2004: In October, the FDA required manufacturers to add a black-box warning to the product label of all antidepressants that contained information on adverse effects such as suicidal thoughts, agitation and impulsivity in children and adolescents.4 A black-box warning is the strongest type of warning that the FDA can require.

The FDA also required that a Medication Guide be given to patients receiving this drug. The FDA-approved guides advise patients of the risks of taking the drugs and of precautions that can be taken. The guides specifically tell patients not to take these drugs for mild depression or anxiety or as a sleeping pill. (Find FDA-approved Medication Guides for SSRIs here.)

2005: In March, the FDA amended the product label of fluvoxamine to include warnings about its use together with tizanidine (ZANAFLEX; a Limited Use drug used for spasticity) and alosetron (LOTRONEX, a Do Not Use drug used to treat irritable bowel syndrome). Fluvoxamine can increase the amounts of each of these drugs in the bloodstream to dangerous levels.[3]

2006: In July, the FDA notified health care professionals and consumers that there may be additional, though rare, risks associated with taking SSRI medications during pregnancy, noted above.

Also in July, the FDA issued a public health advisory warning consumers about the possibility of life-threatening reactions — such as changes in blood pressure or hallucinations — that may be caused by the interaction of triptans and certain antidepressants. As mentioned previously, taking SSRIs or SNRIs with triptans can cause serotonin syndrome.

2007: The FDA announced in May that it would require new black-box warnings concerning the increased risk of suicidal thoughts and behavior in young adults ages 18 to 24 during the first one to two months of treatment with antidepressants. The agency required the new warnings to be printed on the product labels for all antidepressants sold in the United States. The warnings amended an existing black-box warning for children and adolescents.[27]

2009: The FDA approved changes to the product labels of SSRIs and SNRIs describing the risk of developing potentially life-threatening serotonin syndrome or NMS-like reactions. These reactions have been reported with SNRIs and SSRIs alone, but the risk is greatest when these drugs are combined with serotonergic drugs (including triptans), drugs that impair metabolism of serotonin (including MAO [monoamine oxidase] inhibitors), or antipsychotics or other dopamine antagonists.[7]

2017: The FDA updated the drug product label of sertraline (ZOLOFT) to state that the drug should be used with caution in patients with risk factors for QT prolongation.[28]

2020: The Medicines and Healthcare products Regulatory Agency (an agency in the U.K. similar to the FDA) issued an advisory that SSRI drugs may be associated with a small increased risk of bleeding in women following childbirth when the drugs are used during the month before delivery.[29]

2023: The FDA updated the drug product label of SSRIs to warn that when these drugs are used in the month before delivery there is an increased risk of bleeding after giving birth.[30]

Before You Use This Drug [top]

Tell your doctor if you have or have had:

  • allergies to drugs
  • suicidal thoughts or actions
  • kidney or liver problems
  • diabetes
  • epilepsy or seizures
  • history of mania
  • Parkinson’s disease
  • weight loss
  • brain disease or damage
  • pregnancy or are breast-feeding
  • a history of drug abuse or dependence

Tell your doctor about any other drugs you take, including aspirin, herbs, vitamins, and other nonprescription products.

When You Use This Drug [top]

  • Until you know how you react to these drugs, do not drive or perform other activities requiring alertness. These drugs may cause drowsiness.
  • Do not drink alcohol or take other drugs that can cause drowsiness.
  • You may feel dizzy when rising from a lying or sitting position. When getting out of bed, hang your legs over the side of the bed for a few minutes, then get up slowly. When getting up from a chair, stay by the chair until you are sure that you are not dizzy.
  • Stop taking these drugs and check with your doctor as soon as possible if you develop a skin rash or hives.
  • If you develop dryness of the mouth, take sips of water. If dry mouth persists for more than two weeks, check with your doctor.
  • Check with your doctor before you take any other drugs, prescription or nonprescription. These drugs frequently interact with other drugs.
  • The effects of these drugs may last for several weeks after you stop taking them. Do not drink alcohol and heed all other warnings for this time period.
  • Visit your doctor regularly to check on your progess with therapy.

How to Use This Drug [top]

  • If you miss a dose, skip the missed dose and continue with your next scheduled dose. Do not take double doses.
  • Do not stop taking drug abruptly.
  • Do not share your medication with others.
  • Take the drug at the same time(s) each day.
  • Take with or without food.
  • Measure liquid with a calibrated teaspoon.
  • Capsules may be opened and the contents mixed with applesauce, jelly, or ketchup, then swallowed without chewing.
  • If you are taking other drugs, take them one to two hours before taking one of these drugs.
  • Store at room temperature with cap on tightly. Do not store in the bathroom. Do not expose to heat, moisture, or strong light. Keep out of reach of children.
  • Note that it may require four weeks or longer to obtain the desired effects.

Interactions with Other Drugs [top]

The following drugs, biologics (e.g., vaccines, therapeutic antibodies), or foods are listed in Evaluations of Drug Interactions 2003 as causing “highly clinically significant” or “clinically significant” interactions when used together with any of the drugs in this section. In some sections with multiple drugs, the interaction may have been reported for one but not all drugs in this section, but we include the interaction because the drugs in this section are similar to one another. We have also included potentially serious interactions listed in the drug’s FDA-approved professional package insert or in published medical journal articles. There may be other drugs, especially those in the families of drugs listed below, that also will react with this drug to cause severe adverse effects. Make sure to tell your doctor and pharmacist the drugs you are taking and tell them if you are taking any of these interacting drugs:

  • Monoamine oxidase (MAO) inhibitors: deprenyl, ELDEPRYL, furazolidone, FUROXONE, isocarboxazid, MARPLAN, MATULANE, NARDIL, PARNATE, phenelzine, procarbazine, selegiline, tranylcypromine. At least two weeks should elapse between stopping an MAO inhibitor and starting one of these drugs. You should wait at least five weeks after stopping one of these drugs and starting an MAO inhibitor

  • Other interacting drugs for the group are: alosetron, alprazolam, amoxapine, ANAFRANIL, ARICEPT, astemizole, AVENTYL, ayahuasca, carbamazepine, CELEXA, cilostazol, cimetidine, cisapride, citalopram, clomipramine, clozapine, CLOZARIL, COGNEX, cyclosporine, cyproheptadine, delavirdine, desipramine, DESYREL, dextromethorphan, DIFLUCAN, digoxin, DILANTIN, donepezil, doxepin, DURAGESIC, ERYTHROCIN, erythromycin, escitalopram, ESKALITH, fentanyl, fluconazole, HISMANAL, imipramine, IMITREX, INDERAL, IONAMIN, ketorolac, LANOXIN, LEXAPRO, linezolid, lithium, LITHOBID, LITHONATE, LOTRONEX, marijuana, MAXALT, MERIDIA, moclobemide, NORPRAMIN, nortriptyline, NORVIR,ORAP, PERIACTIN, phentermine, phenytoin, pimozode, PLETAL, propranolol, PROPULSID, protriptyline, quinidine, RESCRIPTOR, ritonavir, rizatriptan, SANDIMMUNE, SELDANE, sibutramine, SINEQUAN, sumatriptan, SURMONTIL, tacrine, TAGAMET, TEGRETOL, terfenadine, thioridazine, tizanidine, TOFRANIL, tolbutamide, TORADOL, tramadol, trazodone, trimipramine, tryptophan, ULTRACET, ULTRAM, VIVACTIL, XANAX, ZANAFLEX, zotepine, ZYVOX.

  • Central nervous system (CNS) depressant drugs including alcohol, antidepressants, antihistamines, antipsychotics, some blood pressure medications (reserpine, methyldopa, beta-blockers), motion sickness medications, muscle relaxants, narcotics, sedatives, sleeping pills, and tranquilizers.

Adverse Effects [top]

Call your doctor immediately if you experience:

Signs of allergic reaction or serum sickness–like syndrome:

  • skin rash or hives associated with burning or tingling in fingers, hands, or arms
  • chills or fever
  • swollen glands
  • joint or muscle pain
  • swelling of feet or lower legs, trouble breathing

Signs of hypoglycemia:

  • anxiety
  • chills, cold sweats, confusion, cool, pale skin
  • difficulty concentrating
  • drowsiness
  • excessive hunger
  • fast heartbeat
  • headache
  • nervousness, shakiness, unsteady walk
  • unusual tiredness or weakness

Call your doctor immediately if you experience:

  • suicidal thoughts or behavior
  • abnormal bleeding
  • breast tenderness or secretion of milk in females
  • dizziness or fainting
  • slow, fast, or irregular heartbeat
  • anxiety
  • trouble with urination
  • mood changes
  • trembling or shaking
  • chills, fever, or sore throat
  • joint or muscle pain
  • skin rash, hives, itching, or peeling of skin
  • red, irritated eyes
  • difficulty breathing
  • cold sweats
  • confusion, poor coordination
  • excessive hunger
  • unusual excitement
  • swollen glands
  • swelling of feet or lower legs
  • difficulty speaking
  • dry mouth
  • decreased sexual drive, abnormal ejaculation, or impotence
  • stomach or abdominal cramps
  • black, tarry stools
  • gas
  • diarrhea
  • tiredness or weakness
  • trouble sleeping
  • mania
  • difficult or fast breathing
  • unusual facial or body movements

Call your doctor if these symptoms continue:

  • anxiety and nervousness
  • nausea or vomiting
  • diarrhea
  • increased or decreased appetite, or weight gain or loss
  • constipation
  • gas
  • watering of mouth
  • frequent urination
  • change in sense of taste
  • heartburn
  • drowsiness
  • dry mouth
  • trouble sleeping
  • pain in muscles or joints
  • menstrual pain
  • dizziness or fainting, especially when getting up
  • headache (severe and throbbing)
  • unusual tiredness
  • increased yawning
  • increased sweating
  • tingling, burning, or prickly feelings on skin
  • tooth grinding
  • trembling or shaking
  • disturbing dreams
  • changes in vision
  • chest pain
  • irregular or fast heartbeat
  • stuffy or runny nose
  • cough
  • impaired concentration
  • trembling or quivering
  • feeling of warmth or heat
  • flushing or redness of skin, especially on face and neck
  • decreased libido

Call your doctor if these symptoms occur after you stop taking the drug:

  •   agitation
  •   anxiety
  •   dizziness
  •   fatigue
  •   headache
  •   vision changes
  •   nausea
  •   sweating
  •   general feeling of discomfort or illness
  •   trouble walking
  •   trouble sleeping
  •   confusion
  •   restlessness
  •   muscle pain
  •   trembling or shaking

Signs of overdose:

  •   agitation and restlessness
  •   dizziness, convulsions
  •   seizures
  •   unusual excitement
  •   severe nausea and vomiting
  •   severe drowsiness
  •   dry mouth
  •   irritability
  •   large pupils
  •   fast heartbeat
  •   sweating
  •   diarrhea

If you suspect an overdose, call this number to contact your poison control center: (800) 222-1222.

Periodic Tests[top]

Ask your doctor which of these tests should be done periodically while you are taking this drug:

  •   supervision of depression with suicidal tendencies
  •   blood count
  •   liver function tests
  •   lipid levels in blood

last reviewed January 1, 2024