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Citalopram Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 6000 

Mood Swings, Product Substitution Issue (8465677-2)
on Jun 20, 2012 Male from UNITED STATES , weighting 208.0 lb, was diagnosed with
  • depression
  • anxiety
and was treated with Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: mood swings, product substitution issue. Citalopram Hydrobromide dosage: 40mg Qam Po.

Eye Pain, Intraocular Pressure Increased (8465641-3)
Patient was taking Citalopram Hydrobromide. Patient felt the following Citalopram side effects: eye pain, intraocular pressure increased on Jun 13, 2012 from DENMARK Additional patient health information: Male , 59 years of age, . Citalopram Hydrobromide dosage: 20 Mg.
Multiple prescriptions taken:
  • Cosopt


Extrapyramidal Disorder, Psychotic Disorder (8465566-3)
Adverse event was reported on Jun 12, 2012 by a Female taking Citalopram Hydrobromide (Dosage: N/A) . Location: UNITED KINGDOM , 36 years of age, After Citalopram was administered, patient encountered several Citalopram side effects: extrapyramidal disorder, psychotic disorder.
Multiple concurrent drugs taken:
  • Paliperidone
  • Diazepam
Patient was hospitalized.

Cardiotoxicity, Hypoglycaemia, Shock (8465113-6)
on Jun 02, 2012 Female from UNITED STATES , 56 years of age, was treated with Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: cardiotoxicity, hypoglycaemia, shock. Citalopram Hydrobromide dosage: N/A.
Associated medications used:
  • Lipid Emulsion
  • Metoprolol Succinate
  • Amitriptyline Hcl
  • Nifedipine
Patient was hospitalized.


Headache, Blood Glucose Increased, Oedema Peripheral, Galactorrhoea, Optic Neuritis, Paraesthesia, Mydriasis, Dysaesthesia (8464484-4)
on Jun 12, 2012 Female from GERMANY , 25 years of age, was diagnosed with
  • major depression
  • optic neuritis
  • sleep disorder
and was treated with Citalopram Hydrobromide. Patient felt the following Citalopram side effects: headache, blood glucose increased, oedema peripheral, galactorrhoea, optic neuritis, paraesthesia, mydriasis, dysaesthesia. Citalopram Hydrobromide dosage: 20-60 Mg, Increasing Doses.
Multiple prescriptions taken:
  • Methylprednisolone (1 G, Unk)
  • Zolpidem (5 Mg, Transiently)
  • Methylprednisolone (Dose Reduction Step-by-step With 10 Days)
  • Mirtazapine (15 Up To 30 Mg)


Gait Disturbance, Fall, Inappropriate Antidiuretic Hormone Secretion, Affect Lability (8462290-8)
Patient was taking Citalopram Hydrobromide. After Citalopram was administered, patient encountered several Citalopram side effects: gait disturbance, fall, inappropriate antidiuretic hormone secretion, affect lability on Jun 02, 2012 from SPAIN Additional patient health information: Male , 72 years of age, was diagnosed with
  • depression
and. Citalopram Hydrobromide dosage: N/A. Patient was hospitalized.

Agitation, Psychotic Disorder, Extrapyramidal Disorder (8462224-6)
Adverse event was reported on Jun 13, 2012 by a Female taking Citalopram Hydrobromide (Dosage: 40 Mg) . Location: DENMARK , 36 years of age, Directly after, patient experienced the unwanted or unexpected Citalopram side effects: agitation, psychotic disorder, extrapyramidal disorder. Patient was hospitalized.

Confusional State, Convulsion, Overdose, Respiratory Distress (8459881-7)
on Jun 18, 2012 Female from UNITED STATES , weighting 144.0 lb, was diagnosed with
  • depression
  • pain
  • mental disorder
and was treated with Citalopram Hydrobromide. Patient felt the following Citalopram side effects: confusional state, convulsion, overdose, respiratory distress. Citalopram Hydrobromide dosage: 20 Mg, Qd.
Multiple prescriptions taken:
  • Lortab (7.5 Ukn, Q8h)
  • Klonopin (1 Mg, Bid)
  • Klonopin (2 Mg, Qhs)
  • Lyrica (50 Mg, Bid)
  • Lortab (500 Ukn, Prn)
  • Neurontin (300 Mg, Tid)
  • Prilosec (20 Mg, Qd)
  • Clozaril
Patient was hospitalized.

Hyponatraemia (8459293-6)
on Jun 11, 2012 Female from DENMARK , 79 years of age, was treated with Citalopram Hydrobromide. After Citalopram was administered, patient encountered several Citalopram side effects: hyponatraemia. Citalopram Hydrobromide dosage: N/A.
Multiple concurrent drugs taken:
  • Sulfamethoxazole And Trimethoprim
Patient was hospitalized.

Anxiety, Panic Attack (8459266-3)
Patient was taking Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: anxiety, panic attack on Jun 08, 2012 from GREECE Additional patient health information: Female , 83 years of age, weighting 110.2 lb, was diagnosed with
  • anxiety
and. Citalopram Hydrobromide dosage: 10 Mg, Daily.
Associated medications used:
  • Simvastatin (40 Mg, Daily)


Faeces Discoloured, Gastrointestinal Haemorrhage, Melaena, Haemoglobin Decreased (8459265-1)
Adverse event was reported on Jun 08, 2012 by a Male taking Citalopram Hydrobromide (Dosage: Unk) . Location: UNITED KINGDOM , 61 years of age, Patient felt the following Citalopram side effects: faeces discoloured, gastrointestinal haemorrhage, melaena, haemoglobin decreased.
Multiple prescriptions taken:
  • Calceos


Pneumonia, White Blood Cell Count Decreased (8459110-4)
on Jun 15, 2012 Female from CANADA , weighting 207.2 lb, was treated with Citalopram Hydrobromide. After Citalopram was administered, patient encountered several Citalopram side effects: pneumonia, white blood cell count decreased. Citalopram Hydrobromide dosage: N/A.
Multiple concurrent drugs taken:
  • Mabthera
  • Olanzapine
  • Clonazepam
Patient was hospitalized.

Cerebral Haemorrhage (8457347-1)
on May 23, 2012 Female from ITALY , 78 years of age, was treated with Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: cerebral haemorrhage. Citalopram Hydrobromide dosage: N/A.
Associated medications used:
  • Aspirin (100 Mg, Qd)
  • Enalapril Maleate
  • Enoxaparin Sodium (Daily Dose 4000 Iu)


Toxicity To Various Agents, Arteriosclerosis Coronary Artery (8456674-1)
Patient was taking Citalopram Hydrobromide. Patient felt the following Citalopram side effects: toxicity to various agents, arteriosclerosis coronary artery on Jun 08, 2012 from UNITED STATES Additional patient health information: Female , 56 years of age, weighting 137.0 lb, . Citalopram Hydrobromide dosage: N/A.
Multiple prescriptions taken:
  • Cyanocobalamin
  • Alprazolam
  • Levothyroxine
  • Gabapentin
  • Lisinopril
  • Hydrocodone Bitartrate And Acetaminophen (10mg/500mg)
  • Meloxicam
  • Zolpidem


Accommodation Disorder (8456212-3)
Adverse event was reported on Jun 11, 2012 by a Male taking Citalopram Hydrobromide (Dosage: N/A) was diagnosed with
  • depression
and. Location: DENMARK , 54 years of age, After Citalopram was administered, patient encountered several Citalopram side effects: accommodation disorder.
Multiple concurrent drugs taken:
  • Duloxetime Hydrochloride (60 Mg)


Optic Neuritis, Scotoma, Blood Glucose Increased, Oedema Peripheral, Galactorrhoea, Sleep Disorder, Mydriasis (8455291-7)
on Jun 14, 2012 Female from GERMANY , 25 years of age, was diagnosed with
  • depression
and was treated with Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: optic neuritis, scotoma, blood glucose increased, oedema peripheral, galactorrhoea, sleep disorder, mydriasis. Citalopram Hydrobromide dosage: N/A.
Associated medications used:
  • Opipramol
  • Methylprednisolone (1 G)
  • Methylprednisolone
  • Zolpidem (5 Mg)
  • Mirtazapine


Panic Attack, Anxiety (8454897-9)
on Jun 07, 2012 Female from UNITED KINGDOM , 83 years of age, weighting 110.2 lb, was diagnosed with
  • anxiety
  • depression
and was treated with Citalopram. Patient felt the following Citalopram side effects: panic attack, anxiety. Citalopram dosage: 10 Mg, 1 Days.

Anxiety, Panic Attack (8453946-1)
Patient was taking Citalopram. After Citalopram was administered, patient encountered several Citalopram side effects: anxiety, panic attack on Jun 07, 2012 from UNITED KINGDOM Additional patient health information: Female , 83 years of age, weighting 110.2 lb, was diagnosed with
  • anxiety
  • cerebral infarction
and. Citalopram dosage: N/A.
Multiple concurrent drugs taken:
  • Clopidogrel
  • Simvastatin


Faeces Discoloured, Melaena, Gastrointestinal Haemorrhage, Haemoglobin Decreased (8449120-5)
Adverse event was reported on Jun 08, 2012 by a Male taking Citalopram Hydrobromide (Dosage: N/A) . Location: DENMARK , 61 years of age, Directly after, patient experienced the unwanted or unexpected Citalopram side effects: faeces discoloured, melaena, gastrointestinal haemorrhage, haemoglobin decreased.
Associated medications used:
  • Calceos


Gastrointestinal Haemorrhage, Faeces Discoloured, Haemoglobin Decreased, Melaena (8448834-0)
on Jun 07, 2012 Male from UNITED KINGDOM , 61 years of age, was treated with Citalopram Hydrobromide. Patient felt the following Citalopram side effects: gastrointestinal haemorrhage, faeces discoloured, haemoglobin decreased, melaena. Citalopram Hydrobromide dosage: Oral.
Multiple prescriptions taken:
  • Calceos (lekovit Ca)


Tachycardia, Muscle Contractions Involuntary, Serotonin Syndrome, Gait Disturbance, Blood Pressure Increased, Underdose, Tremor, Dysphemia (8446938-X)
on Jun 13, 2012 Female from UNITED STATES , 24 years of age, weighting 240.3 lb, was diagnosed with
  • panic attack
and was treated with Citalopram Hydrobromide. After Citalopram was administered, patient encountered several Citalopram side effects: tachycardia, muscle contractions involuntary, serotonin syndrome, gait disturbance, blood pressure increased, underdose, tremor, dysphemia. Citalopram Hydrobromide dosage: 10 Mg Daily Po. Patient was hospitalized.

Post Procedural Complication, Status Epilepticus, Facial Paresis, Nuclear Magnetic Resonance Imaging Brain Abnormal, Peritonitis, Grand Mal Convulsion, Hemiparesis, Blood Glucose Increased, No Therapeutic Response (8446388-6)
Patient was taking Citalopram Hydrobromide. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: post procedural complication, status epilepticus, facial paresis, nuclear magnetic resonance imaging brain abnormal, peritonitis, grand mal convulsion, hemiparesis, blood glucose increased, no therapeutic response on Jun 08, 2012 from DENMARK Additional patient health information: Female , 72 years of age, . Citalopram Hydrobromide dosage: N/A.
Associated medications used:
  • Bendroflumethiazide
  • Lisinopril
  • Lansoprazole
Patient was hospitalized.

Peripheral Coldness, Electrocardiogram Qrs Complex Prolonged, Grand Mal Convulsion, Unresponsive To Stimuli, Miosis, Flushing, Pupil Fixed, Hypotension (8444937-5)
Adverse event was reported on May 29, 2012 by a Female taking Citalopram Hydrobromide (Dosage: (maximum Ingestion Of 1.8 G Oral)) . Location: UNITED STATES , 24 years of age, Patient felt the following Citalopram side effects: peripheral coldness, electrocardiogram qrs complex prolonged, grand mal convulsion, unresponsive to stimuli, miosis, flushing, pupil fixed, hypotension.
Multiple prescriptions taken:
  • Trazodone Hcl ((maximum Ingestion Of 4.5 G Oral))
  • Bupropion Hcl ((maximum Ingestion Of 13.5 G Oral))
  • Clonazepam ((maximum Ingestion Of 90 Mg Oral))
Patient was hospitalized.

Urinary Incontinence, Mydriasis, Electrocardiogram Qt Prolonged, Encephalopathy, Somnolence, Flushing, Incoherent, Nasopharyngitis, Off Label Use (8444725-X)
on May 26, 2012 Male from UNITED STATES , child 8 years of age, was diagnosed with
  • post-traumatic stress disorder
  • off label use
  • attention deficit/hyperactivity disorder
and was treated with Citalopram Hydrobromide. After Citalopram was administered, patient encountered several Citalopram side effects: urinary incontinence, mydriasis, electrocardiogram qt prolonged, encephalopathy, somnolence, flushing, incoherent, nasopharyngitis, off label use. Citalopram Hydrobromide dosage: N/A. Patient was hospitalized.

Panic Attack, Anxiety (8444049-0)
on Jun 08, 2012 Female from UNITED KINGDOM , 83 years of age, weighting 110.2 lb, was diagnosed with
  • anxiety
and was treated with Citalopram. Directly after, patient experienced the unwanted or unexpected Citalopram side effects: panic attack, anxiety. Citalopram dosage: N/A.
Associated medications used:
  • Simvastatin
  • Clopidogrel Bisulfate


Showing 1-25 of 6000 

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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.

Citalopram Information

Alternative CITALOPRAM Names:CITALOPRA ESCITALOP ESCITSLOP

Active Ingredient: CITALOPRA ESCITALOP

Citalopram Dosage, Warnings, Usage.

Side Effects reported to FDA: 6000. View Citalopram Adverse Reports

Citalopram safety alerts: 2012 2011 2007 2005

Reported deaths: 867

Reported hospitalizations: 1929

Celexa (citalopram hydrobromide) - Drug Safety Communication: Revised Recommendations, Potential Risk of Abnormal Heart Rhythms

 

[Posted 03/28/2012]

AUDIENCE: Psychiatry, Cardiology

ISSUE: FDA is clarifying dosing and warning recommendations for the antidepressant Celexa (citalopram hydrobromide; also available in generic form). In August 2011, FDA issued a Drug Safety Communication (DSC) stating that citalopram should no longer be used at doses greater than 40 mg per day because it could cause potentially dangerous abnormalities in the electrical activity of the heart. Citalopram use at any dose is discouraged in patients with certain conditions because of the risk of QT prolongation, but because it may be important for some of those patients to use citalopram, the drug label has been changed to describe the particular caution that needs to be taken when citalopram is used in such patients. The revised drug label also describes lower doses that should be used in patients over 60 years of age.

Read the FDA Drug Safety Communication for additional information.

BACKGROUND: Celexa (citalopram hydrobromide; also available in generic form) is in a class of antidepressants called selective serotonin reuptake inhibitors (SSRIs).

RECOMMENDATIONS:

  • Citalopram is not recommended for use at doses greater than 40 mg per day because such doses cause too large an effect on the QT interval and confer no additional benefit.
  • Citalopram is not recommended for use in patients with congenital long QT syndrome, bradycardia, hypokalemia, or hypomagnesemia, recent acute myocardial infarction, or uncompensated heart failure. 
  • Citalopram use is also not recommended in patients who are taking other drugs that prolong the QT interval.
  • The maximum recommended dose of citalopram is 20 mg per day for patients with hepatic impairment, patients who are older than 60 years of age, patients who are CYP 2C19 poor metabolizers, or patients who are taking concomitant cimetidine (Tagamet) or another CYP2C19 inhibitor, because these factors lead to increased blood levels of citalopram, increasing the risk of QT interval prolongation and Torsade de Pointes.

See the FDA Drug Safety Communication for additional recommendations for healthcare professionals and patients.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[03/28/2012 - Drug Safety Communication - FDA]

Previous MedWatch Alert:

[08/24/2011]

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