DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Prozac (Fluoxetine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Prozac (Fluoxetine) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (872)
Death (58)
Life Threatening Events (55)
Disability (17)

Reports by Reaction Type

Foetal Exposure During Pregnancy (402)Drug Ineffective (74)Talipes (55)Ventricular Septal Defect (46)Atrial Septal Defect (44)Anxiety (42)Depression (40)Cleft Palate (35)Suicidal Ideation (33)Weight Increased (32)Nausea (30)Fallot's Tetralogy (30)

Below are a few examples of reports where side effects / adverse reactions may be related to Prozac (Fluoxetine). For a complete list or a specific selection of reports, please use the links above.

Possible Prozac side effects in 30 year old female

Reported by a physician from France on 2012-08-27

Patient: 30 year old female

Reactions: Premature Rupture of Membranes, Maternal Exposure During Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prozac



Possible Prozac side effects in

Reported by a physician from United States on 2012-08-24

Patient:

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Prozac
    Dosage: unk

Xanax
    Dosage: unk



Possible Prozac side effects in 17 year old male

Reported by a physician from United Kingdom on 2012-08-24

Patient: 17 year old male

Reactions: Self Injurious Behaviour, Hallucination, Depressed Mood, Suicidal Ideation

Drug(s) suspected as cause:
Prozac
    Dosage: 20 mg, qd
    Indication: Major Depression

Prozac
    Dosage: 20 mg, bid
    Start date: 2012-05-01



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Cleft LIP, Cleft Palate, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Foetal Exposure During Pregnancy, Pyloric Stenosis

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Foetal Exposure During Pregnancy, Talipes

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-23

Patient: 80 year old male

Reactions: C-Reactive Protein Increased, Rash Maculo-Papular, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atorvastatin
    Dosage: 80 mg, one dosage form daily
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-01-05
    End date: 2012-01-17

Lovenox
    Dosage: 4000 iu, daily
    Indication: Prophylaxis
    Start date: 2012-01-02
    End date: 2012-01-17

Pantoprazole
    Dosage: 20 mg, one dosage form daily
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2012-01-03
    End date: 2012-01-17

Prozac
    Dosage: 20 mg, one dosage form daily
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-11
    End date: 2012-01-17

Other drugs received by patient: Valsartan; Aspirin



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-23

Patient:

Reactions: Fallot's Tetralogy, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in 47 year old female

Reported by a physician from United States on 2012-08-22

Patient: 47 year old female

Reactions: Agitation, Anxiety, Drug Interaction, Serotonin Syndrome, Depression, Headache, Hypertension

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Prozac
    Dosage: 20 mg, unk
    Indication: Depression

Prozac
    Dosage: 40 mg, unk

Strattera
    Dosage: 18 mg, unk
    Indication: Attention Deficit / Hyperactivity Disorder

Strattera
    Dosage: 25 mg, unk

Other drugs received by patient: Lexapro



Possible Prozac side effects in 79 year old female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: 79 year old female

Reactions: Abdominal Pain, Agitation, Pruritus, Restless Legs Syndrome, Orthostatic Hypotension, Disorientation, Pharyngeal Oedema, Dyspepsia, Palpitations, Feeling of Body Temperature Change, Muscle Spasms, Blood Pressure Increased, Nightmare, Nausea, Hypotension, Blood Creatine Increased, Tremor, Anxiety, Heart Rate Decreased, Arthralgia, Diarrhoea

Drug(s) suspected as cause:
Cardura
    Dosage: unk

Cartia XT
    Dosage: unk

Celebrex
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Cymbalta
    Dosage: unk

Diltiazem
    Dosage: unk

Diovan
    Dosage: unk

Fentanyl
    Dosage: unk

Levaquin

Macrobid
    Dosage: unk

Micardis
    Dosage: unk

Mirtazapine
    Dosage: unk

Naproxen Sodium
    Dosage: unk

Norvasc
    Dosage: unk

Paxil
    Dosage: unk

Prozac
    Dosage: unk

Tekturna
    Dosage: unk

Tiazac
    Dosage: unk

Toprol-XL

Vasotec
    Dosage: unk

Wellbutrin XL
    Dosage: unk

Zoloft
    Dosage: unk

Other drugs received by patient: Effexor XR; Protonix



Possible Prozac side effects in 57 year old female

Reported by a physician from United States on 2012-08-20

Patient: 57 year old female

Reactions: Chest Pain, Drug Hypersensitivity

Drug(s) suspected as cause:
Celexa
    Dosage: unk

Ciprofloxacin HCL
    Dosage: unk

Gabapentin
    Dosage: unk

Hydrocodone Bitartrate + Acetaminophen
    Dosage: unk

Iodine
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Oxycontin
    Dosage: unk

Povidone-Iodine (Formula 47)
    Dosage: unk

Prozac
    Dosage: unk

Secretin INJ
    Dosage: unk

Seroquel
    Dosage: unk

Titanium Dioxide
    Dosage: unk

Zyprexa
    Dosage: unk



Possible Prozac side effects in male

Reported by a lawyer from United States on 2012-08-20

Patient: male

Reactions: Foetal Exposure During Pregnancy, Plagiocephaly

Drug(s) suspected as cause:
Paxil
    Indication: Depression
    End date: 2005-07-01

Prozac



Possible Prozac side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-20

Patient: 80 year old male

Reactions: C-Reactive Protein Increased, Leukocytosis, Rash Maculo-Papular

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atorvastatin
    Dosage: 80 mg, one dosage form daily
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-01-05
    End date: 2012-01-17

Lovenox
    Dosage: 4000 iu, daily
    Indication: Prophylaxis
    Start date: 2012-01-02
    End date: 2012-01-17

Pantoprazole
    Dosage: 20 mg, one dosage form daily
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2012-01-03
    End date: 2012-01-17

Prozac
    Dosage: 20 mg, one dosage form daily
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-11
    End date: 2012-01-17

Other drugs received by patient: Aspirin; Valsartan



Possible Prozac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient: female

Reactions: Irritability, Agitation, Fatigue, Nausea, Headache, Depression

Drug(s) suspected as cause:
Chantix
    Dosage: 1 mg, 2x/day
    Start date: 2012-08-01

Chantix
    Dosage: 0.5 mg, daily
    Start date: 2012-08-01
    End date: 2012-08-01

Prozac
    Dosage: 40 mg, daily
    Indication: Depression

Other drugs received by patient: Insulin



Possible Prozac side effects in 38 year old female

Reported by a consumer/non-health professional from Spain on 2012-08-17

Patient: 38 year old female

Reactions: Electrocardiogram QT Prolonged, Syncope, Ventricular Tachycardia, Drug Interaction

Adverse event resulted in: life threatening event

Drug(s) suspected as cause:
Prozac

Other drugs received by patient: Tiaprizal; Trazodona; Diazepam



Possible Prozac side effects in 41 year old female

Reported by a consumer/non-health professional from United Kingdom on 2012-08-17

Patient: 41 year old female

Reactions: Dyspnoea, Sedation, Drug Interaction

Drug(s) suspected as cause:
Prozac

Other drugs received by patient: Clozaril



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-17

Patient:

Reactions: Foetal Exposure During Pregnancy, Talipes

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient:

Reactions: Premature Baby, Foetal Exposure During Pregnancy, Neonatal Disorder

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: female

Reactions: Atrial Septal Defect, Renal Disorder, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient:

Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy, Adverse Event, Talipes

Drug(s) suspected as cause:
Prozac
    Dosage: unk, unknown

Prozac
    Dosage: unk, unknown



Possible Prozac side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient: female

Reactions: Pulmonary Valve Stenosis Congenital, Fallot's Tetralogy, Foetal Exposure During Pregnancy, Ventricular Septal Defect

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Congenital Spinal Cord Anomaly, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Cleft LIP and Palate, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Cleft LIP, Cardiac Murmur, Cleft Palate, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Atrial Septal Defect, Pulmonary Valve Stenosis, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Congenital Cardiovascular Anomaly

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Neurogenic Bladder, Spina Bifida, Foetal Exposure During Pregnancy

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in 80 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2012-08-14

Patient: 80 year old male

Reactions: C-Reactive Protein Increased, Rash Maculo-Papular, Leukocytosis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Atorvastatin
    Dosage: 80 mg, daily
    Administration route: Oral
    Indication: Dyslipidaemia
    Start date: 2012-01-05
    End date: 2012-01-17

Lovenox
    Dosage: 4000 iu, daily
    Indication: Prophylaxis
    Start date: 2012-01-02
    End date: 2012-01-17

Pantoprazole
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Prophylaxis Against Gastrointestinal Ulcer
    Start date: 2012-01-03
    End date: 2012-01-17

Prozac
    Dosage: 20 mg, daily
    Administration route: Oral
    Indication: Depression
    Start date: 2012-01-11
    End date: 2012-01-17

Other drugs received by patient: Aspirin; Valsartan



Possible Prozac side effects in

Reported by a physician from United Kingdom on 2012-08-14

Patient:

Reactions: Exposure During Breast Feeding, Foetal Exposure During Pregnancy, Feeding Disorder Neonatal, Ankyloglossia Congenital

Drug(s) suspected as cause:
Prozac
    Dosage: unk

Prozac
    Dosage: unk



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Atrial Septal Defect, Foetal Exposure During Pregnancy, Ventricular Septal Defect, Cardiac Failure Congestive

Drug(s) suspected as cause:
Prozac

Prozac



Possible Prozac side effects in

Reported by a consumer/non-health professional from United States on 2012-08-14

Patient:

Reactions: Fallot's Tetralogy, Foetal Exposure During Pregnancy, Ventricular Septal Defect

Drug(s) suspected as cause:
Prozac

Prozac

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014