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Geodon

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Geodon

Geodon

Geodon Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Geodon (ziprasidone HCl and ziprasidone mesylate) is a member of the class of prescription medicine called psychotropics. Geodon (ziprasidone HCl) is available as capsules and Geodon (ziprasidone mesylate) is available as an injection for intramuscular use. Geodon is also known as an atypical antipsychotic, and it is used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. Geodon also can be used as maintenance treatment of bipolar disorder when added to lithium or valproate. Possible serious side effects include fainting or loss of consciousness or heart palpitations. Common side effects include the following and should be discussed with your doctor if they occur: feeling unusually tired or sleepy; nausea or upset stomach; constipation; dizziness; restlessness; abnormal muscle movements, such as tremor, shuffling, and uncontrolled involuntary movements; diarrhea; rash; and increased cough or runny nose. This is not a complete list of side effects, and others may occur.

Drug interactions and warnings include that caution should be used when Geodon is taken in combination with other centrally acting drugs. Due to its potential for inducing hypotension, Geodon may enhance the effects of certain antihypertensive agents and may antagonize the effects of levodopa and dopamine agonists. Geodon should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women receiving Geodon should not breastfeed.

Our Geodon Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Geodon in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ziprasidone and call your doctor at once if you have a serious side effect such as:

  • dizziness, feeling light-headed, fainting, fast or pounding heartbeat;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats;
  • fever, chills, body aches, flu symptoms;
  • white patches or sores inside your mouth or on your lips;
  • tremor (uncontrolled shaking), restless muscle movements in your eyes, tongue, jaw, or neck;
  • agitation, hostility, confusion;
  • increased thirst or urination, weakness, extreme hunger; or
  • penis erection that is painful or lasts 4 hours or longer.

Less serious side effects may include:

  • mild skin rash;
  • anxiety, headache, depressed mood;
  • dizziness, drowsiness;
  • muscle pain or twitching;
  • nausea, vomiting, loss of appetite;
  • runny or stuffy nose, cough, sore throat; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Geodon (Ziprasidone) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Geodon Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness, drowsiness, weakness, nausea, vomiting, runny nose, and cough may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe/persistent dizziness, mental/mood changes (e.g., agitation, anxiety, depression, suicidal thoughts), feelings of restlessness, mask-like facial expression (pseudoparkinsonism), shakiness (tremors), muscle spasm/stiffness, numbness/tingling, trouble swallowing, vision problems, difficulty walking, signs of infection (such as fever, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fainting, jaw/left arm pain, slow/fast/irregular heartbeat, seizures.

This drug may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual uncontrolled movements (especially of the face, mouth, tongue, arms or legs).

This medication may rarely cause a very serious condition called serotonin syndrome. The risk may increase when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including SSRIs (e.g., citalopram, paroxetine) and SNRIs (e.g., duloxetine, venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). Before taking this drug, tell your doctor if you take any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, unusual restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.

Medications used for a similar purpose to ziprasidone may infrequently cause a serious (rarely fatal) nervous system disorder called neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you notice any of the following rare but very serious side effects: confusion, fever, fast heartbeat, muscle stiffness, increased sweating.

In rare instances, this medication may increase your level of a certain chemical made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missing/stopped periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop these symptoms, tell your doctor immediately.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Geodon (Ziprasidone)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Geodon FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical trials for oral ziprasidone included approximately 5700 patients and/or normal subjects exposed to one or more doses of ziprasidone. Of these 5700, over 4800 were patients who participated in multiple-dose effectiveness trials, and their experience corresponded to approximately 1831 patient-years. These patients include: (1) 4331 patients who participated in multiple-dose trials, predominantly in schizophrenia, representing approximately 1698 patient-years of exposure as of February 5, 2000; and (2) 472 patients who participated in bipolar mania trials representing approximately 133 patient-years of exposure. An additional 127 patients with bipolar disorder participated in a long-term maintenance treatment study representing approximately 74.7 patient-years of exposure to ziprasidone. The conditions and duration of treatment with ziprasidone included open-label and double-blind studies, inpatient and outpatient studies, and short-term and longer-term exposure.

Clinical trials for intramuscular ziprasidone included 570 patients and/or normal subjects who received one or more injections of ziprasidone. Over 325 of these subjects participated in trials involving the administration of multiple doses.

Adverse reactions during exposure were obtained by collecting voluntarily reported adverse experiences, as well as results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations.

The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation.

Adverse Findings Observed in Short-Term, Placebo-Controlled Trials with Oral Ziprasidone

The following findings are based on the short-term placebo-controlled premarketing trials for schizophrenia (a pool of two 6-week, and two 4-week fixed-dose trials) and bipolar mania (a pool of two 3-week flexible-dose trials) in which ziprasidone was administered in doses ranging from 10 to 200 mg/day.

Commonly Observed Adverse Reactions in Short Term-Placebo-Controlled Trials

The following adverse reactions were the most commonly observed adverse reactions associated with the use of ziprasidone (incidence of 5% or greater) and not observed at an equivalent incidence among placebo-treated patients (ziprasidone incidence at least twice that for placebo):

Schizophrenia trials (see Table 11)

Bipolar trials (see Table 12)

  • Somnolence
  • Extrapyramidal Symptoms which includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
  • Dizziness which includes the adverse reaction terms dizziness and lightheadedness.
  • Akathisia
  • Abnormal Vision
  • Asthenia
  • Vomiting

Schizophrenia

Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials of Oral Ziprasidone

Approximately 4.1% (29/702) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 2.2% (6/273) on placebo. The most common reaction associated with dropout was rash, including 7 dropouts for rash among ziprasidone patients (1%) compared to no placebo patients [see WARNINGS AND PRECAUTIONS].

Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials

Table 11 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 6 weeks) in predominantly patients with schizophrenia, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Table 11: Treatment-Emergent Adverse Reaction Incidence In Short-Term Oral Placebo-Controlled Trials - Schizophrenia

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone
(N=702)
Placebo
(N=273)
Body as a Whole
  Asthenia 5 3
  Accidental Injury 4 2
  Chest Pain 3 2
Cardiovascular
  Tachycardia 2 1
Digestive
  Nausea 10 7
  Constipation 9 8
  Dyspepsia 8 7
  Diarrhea 5 4
  Dry Mouth 4 2
  Anorexia 2 1
Nervous
  Extrapyramidal Symptoms* 14 8
  Somnolence 14 7
  Akathisia 8 7
  Dizziness** 8 6
Respiratory
  Respiratory Tract Infection 8 3
  Rhinitis 4 2
  Cough Increased 3 1
Skin and Appendages
  Rash 4 3
  Fungal Dermatitis 2 1
Special Senses
  Abnormal Vision 3 2
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 5% in schizophrenia trials.
** Dizziness includes the adverse reaction terms dizziness and lightheadedness.

Dose Dependency of Adverse Reactions in Short-Term, Fixed-Dose, Placebo-Controlled Trials

An analysis for dose response in the schizophrenia 4-study pool revealed an apparent relation of adverse reaction to dose for the following reactions: asthenia, postural hypotension, anorexia, dry mouth, increased salivation, arthralgia, anxiety, dizziness, dystonia, hypertonia, somnolence, tremor, rhinitis, rash, and abnormal vision.

Extrapyramidal Symptoms (EPS) - The incidence of reported EPS (which included the adverse reaction terms extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching) for ziprasidone-treated patients in the short-term, placebo-controlled schizophrenia trials was 14% vs. 8% for placebo. Objectively collected data from those trials on the Simpson-Angus Rating Scale (for EPS) and the Barnes Akathisia Scale (for akathisia) did not generally show a difference between ziprasidone and placebo.

Dystonia - Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Vital Sign Changes - Ziprasidone is associated with orthostatic hypotension [see WARNINGS AND PRECAUTIONS]

ECG Changes - Ziprasidone is associated with an increase in the QTc interval [see WARNINGS AND PRECAUTIONS]. In the schizophrenia trials, ziprasidone was associated with a mean increase in heart rate of 1.4 beats per minute compared to a 0.2 beats per minute decrease among placebo patients.

Other Adverse Reactions Observed During the Premarketing Evaluation of Oral Ziprasidone

Following is a list of COSTART terms that reflect treatment-emergent adverse reactions as defined in the introduction to the ADVERSE REACTIONS section reported by patients treated with ziprasidone in schizophrenia trials at multiple doses > 4 mg/day within the database of 3834 patients. All reported reactions are included except those already listed in Table 11 or elsewhere in labeling, those reaction terms that were so general as to be uninformative, reactions reported only once and that did not have a substantial probability of being acutely life-threatening, reactions that are part of the illness being treated or are otherwise common as background reactions, and reactions considered unlikely to be drug-related. It is important to emphasize that, although the reactions reported occurred during treatment with ziprasidone, they were not necessarily caused by it.

Adverse reactions are further categorized by body system and listed in order of decreasing frequency according to the following definitions:

Frequent - adverse reactions occurring in at least 1/100 patients ( ≥ 1.0% of patients) (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing);

Infrequent - adverse reactions occurring in 1/100 to 1/1000 patients (in 0.1-1.0% of patients)

Rare - adverse reactions occurring in fewer than 1/1000 patients ( < 0.1% of patients).

Body as a Whole

Frequent abdominal pain, flu syndrome, fever, accidental fall, face edema, chills, photosensitivity reaction, flank pain, hypothermia, motor vehicle accident

Cardiovascular System

Frequent tachycardia, hypertension, postural hypotension

Infrequent bradycardia, angina pectoris, atrial fibrillation

Rare first degree AV block, bundle branch block, phlebitis, pulmonary embolus, cardiomegaly, cerebral infarct, cerebrovascular accident, deep thrombophlebitis, myocarditis, thrombophlebitis

Digestive System

Frequent anorexia, vomiting

Infrequent rectal hemorrhage, dysphagia, tongue edema

Rare gum hemorrhage, jaundice, fecal impaction, gamma glutamyl transpeptidase increased, hematemesis, cholestatic jaundice, hepatitis, hepatomegaly, leukoplakia of mouth, fatty liver deposit, melena

Endocrine

Rare hypothyroidism, hyperthyroidism, thyroiditis

Hemic and Lymphatic System

Infrequent anemia, ecchymosis, leukocytosis, leukopenia, eosinophilia, lymphadenopathy

Rare thrombocytopenia, hypochromic anemia, lymphocytosis, monocytosis, basophilia, lymphedema, polycythemia, thrombocythemia

Metabolic and Nutritional Disorders

Infrequent thirst, transaminase increased, peripheral edema, hyperglycemia, creatine phosphokinase increased, alkaline phosphatase increased, hypercholesteremia, dehydration, lactic dehydrogenase increased, albuminuria, hypokalemia

Rare BUN increased, creatinine increased, hyperlipemia, hypocholesteremia, hyperkalemia, hypochloremia, hypoglycemia, hyponatremia, hypoproteinemia, glucose tolerance decreased, gout, hyperchloremia, hyperuricemia, hypocalcemia, hypoglycemicreaction, hypomagnesemia, ketosis, respiratory alkalosis

Musculoskeletal System

Frequent myalgia

Infrequent tenosynovitis

Rare myopathy

Nervous System

Frequent agitation, extrapyramidal syndrome, tremor, dystonia, hypertonia, dyskinesia, hostility, twitching, paresthesia, confusion, vertigo, hypokinesia, hyperkinesia, abnormal gait, oculogyric crisis, hypesthesia, ataxia, amnesia, cogwheel rigidity, delirium, hypotonia, akinesia, dysarthria, withdrawal syndrome, buccoglossal syndrome, choreoathetosis, diplopia, incoordination, neuropathy

Infrequent paralysis

Rare myoclonus, nystagmus, torticollis, circumoral paresthesia, opisthotonos, reflexes increased, trismus

Respiratory System

Frequent dyspnea

Infrequent pneumonia, epistaxis

Rare hemoptysis, laryngismus

Skin and Appendages

Infrequent maculopapular rash, urticaria, alopecia, eczema, exfoliative dermatitis, contact dermatitis, vesiculobullous rash

Special Senses

Frequent fungal dermatitis

Infrequent conjunctivitis, dry eyes, tinnitus, blepharitis, cataract, photophobia

Rare eye hemorrhage, visual field defect, keratitis, keratoconjunctivitis

Urogenital System

Infrequent impotence, abnormal ejaculation, amenorrhea, hematuria, menorrhagia, female lactation, polyuria, urinary retention metrorrhagia, male sexual dysfunction, anorgasmia, glycosuria

Rare gynecomastia, vaginal hemorrhage, nocturia, oliguria, female sexual dysfunction, uterine hemorrhage

Bipolar Disorder

Acute Treatment of Manic or Mixed Episodes

Adverse Reactions Associated with Discontinuation of Treatment in Short Term, Placebo-Controlled Trials

Approximately 6.5% (18/279) of ziprasidone-treated patients in short-term, placebo-controlled studies discontinued treatment due to an adverse reaction, compared with about 3.7% (5/136) on placebo. The most common reactions associated with dropout in the ziprasidone-treated patients were akathisia, anxiety, depression, dizziness, dystonia, rash and vomiting, with 2 dropouts for each of these reactions among ziprasidone patients (1%) compared to one placebo patient each for dystonia and rash (1%) and no placebo patients for the remaining adverse reactions.

Adverse Reactions Occurring at an Incidence of 2% or More Among Ziprasidone-Treated Patients in Short-Term, Oral, Placebo-Controlled Trials

Table 12 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy (up to 3 weeks) in patients with bipolar mania, including only those reactions that occurred in 2% or more of patients treated with ziprasidone and for which the incidence in patients treated with ziprasidone was greater than the incidence in placebo-treated patients.

Table 12: Treatment-Emergent Adverse Reactions Incidence In Short-Term Oral Placebo-Controlled Trials - Manic and Mixed Episodes Associated with Bipolar Disorder

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone
(N=279)
Placebo
(N=136)
Body as a Whole
  Headache 18 17
  Asthenia 6 2
  Accidental Injury 4 1
Cardiovascular
  Hypertension 3 2
Digestive
  Nausea 10 7
  Diarrhea 5 4
  Dry Mouth 5 4
  Vomiting 5 2
  Increased Salivation 4 0
  Tongue Edema 3 1
  Dysphagia 2 0
Musculoskeletal
  Myalgia 2 0
Nervous
  Somnolence 31 12
  Extrapyramidal Symptoms* 31 12
  Dizziness** 16 7
  Akathisia 10 5
  Anxiety 5 4
  Hypesthesia 2 1
  Speech Disorder 2 0
Respiratory
  Pharyngitis 3 1
  Dyspnea 2 1
Skin and Appendages
  Fungal Dermatitis 2 1
Special Senses
  Abnormal Vision 6 3
* Extrapyramidal Symptoms includes the following adverse reaction terms: extrapyramidal syndrome, hypertonia, dystonia, dyskinesia, hypokinesia, tremor, paralysis and twitching. None of these adverse reactions occurred individually at an incidence greater than 10% in bipolar mania trials.
** Dizziness includes the adverse reaction terms dizziness and lightheadedness.

Explorations for interactions on the basis of gender did not reveal any clinically meaningful differences in the adverse reaction occurrence on the basis of this demographic factor.

Intramuscular Ziprasidone

Adverse Reactions Occurring at an Incidence of 1% or More Among Ziprasidone-Treated Patients in Short-Term Trials of Intramuscular Ziprasidone

Table 13 enumerates the incidence, rounded to the nearest percent, of treatment-emergent adverse reactions that occurred during acute therapy with intramuscular ziprasidone in 1% or more of patients.

In these studies, the most commonly observed adverse reactions associated with the use of intramuscular ziprasidone (incidence of 5% or greater) and observed at a rate on intramuscular ziprasidone (in the higher dose groups) at least twice that of the lowest intramuscular ziprasidone group were headache (13%), nausea (12%), and somnolence (20%).

Table 13: Treatment-Emergent Adverse Reaction Incidence In Short-Term Fixed-Dose Intramuscular Trials

Body System/Adverse Reaction Percentage of Patients Reporting Reaction
Ziprasidone 2 mg
(N=92)
Ziprasidone 10 mg
(N=63)
Ziprasidone 20 mg
(N=41)
Body as a Whole
  Headache 3 13 5
  Injection Site Pain 9 8 7
  Asthenia 2 0 0
   Abdominal Pain 0 2 0
  Flu Syndrome 1 0 0
  Back Pain 1 0 0
Cardiovascular
  Postural Hypotension 0 0 5
  Hypertension 2 0 0
  Bradycardia 0 0 2
  Vasodilation 1 0 0
Digestive
  Nausea 4 8 12
  Rectal Hemorrhage 0 0 2
  Diarrhea 3 3 0
  Vomiting 0 3 0
  Dyspepsia 1 3 2
  Anorexia 0 2 0
  Constipation 0 0 2
  Tooth Disorder 1 0 0
  Dry Mouth 1 0 0
Nervous
  Dizziness 3 3 10
  Anxiety 2 0 0
  Insomnia 3 0 0
  Somnolence 8 8 20
  Akathisia 0 2 0
  Agitation 2 2 0
  Extrapyramidal Syndrome 2 0 0
  Hypertonia 1 0 0
  Cogwheel Rigidity 1 0 0
  Paresthesia 0 2 0
  Personality Disorder 0 2 0
  Psychosis 1 0 0
  Speech Disorder 0 2 0
Respiratory
  Rhinitis 1 0 0
Skin and Appendages
  Furunculosis 0 2 0
  Sweating 0 0 2
Urogenital
  Dysmenorrhea 0 2 0
  Priapism 1 0 0

Postmarketing Experience

The following adverse reactions have been identified during post approval use of GEODON. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Adverse reaction reports not listed above that have been received since market introduction include rare occurrences of the following : Cardiac Disorders: Tachycardia, torsade de pointes (in the presence of multiple confounding factors), [see WARNINGS AND PRECAUTIONS]; Digestive System Disorders: Swollen Tongue; Reproductive System and Breast Disorders: Galactorrhea, priapism; Nervous System Disorders: Facial Droop, neuroleptic malignant syndrome, serotonin syndrome (alone or in combination with serotonergic medicinal products), tardive dyskinesia; Psychiatric Disorders: Insomnia, mania/hypomania; Skin and subcutaneous Tissue Disorders: Allergic reaction (such as allergic dermatitis, angioedema, orofacial edema, urticaria), rash; Urogenital System Disorders: Enuresis, urinary incontinence; Vascular Disorders: Postural hypotension, syncope.

Read the entire FDA prescribing information for Geodon (Ziprasidone) »

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Geodon - User Reviews

Geodon User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Geodon sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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