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Tofranil (Imipramine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Tofranil (Imipramine) 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 (21)
Death (2)

Reports by Reaction Type

Confusional State (7)Bipolar Disorder (6)Somnolence (5)Weight Increased (4)Fatigue (4)Agitation (3)Drug Ineffective (3)Chronic Obstructive Pulmonary Disease (3)Mania (3)Dyspepsia (3)Chest Pain (3)Nightmare (3)

Possible Tofranil side effects in 56 year old female

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

Patient: 56 year old female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Tetracycline HCL
    Dosage: unk

Tofranil
    Dosage: unk



Possible Tofranil side effects in female

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

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Trileptal

Tizanidine Hydrochloride
    Indication: Migraine

Depakote

Darvocet-N 50

Skelaxin

Prozac

Paxil

Lunesta

Beta Blocking Agents

Topamax

Zonegran

Valium
    Indication: Agitation

Reglan

Abilify

Elavil

Zyprexa

Tegretol

Requip

MAO Inhibitors

Remeron

Buspar

Adderall

Erythromycin

Ritalin

Effexor

Sumatriptan

Wellbutrin

Tofranil

Zoloft

Daytrana

Antidepressants

Steroids NOS

Desyrel

Neurontin

Sinequan

Seroquel

Pamelor

Other drugs received by patient: Aspirin; Vitamin B-Complex, Other Combinations; Ensure; Caltrate +D; ONE A DAY



Possible Tofranil side effects in 60 year old female

Reported by a physician from United States on 2012-08-09

Patient: 60 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Butazolidin Alka
    Dosage: unk

Tofranil
    Dosage: unk

Pseudoephedrine
    Dosage: unk

Limbitrol
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Stadol
    Dosage: unk



Possible Tofranil side effects in 60 year old female

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

Patient: 60 year old female

Reactions: NO Adverse Event

Drug(s) suspected as cause:
Codeine Sulfate
    Dosage: unk

Butazolidin Alka
    Dosage: unk

Tofranil
    Dosage: unk

Limbitrol
    Dosage: unk

Pseudoephedrine HCL
    Dosage: unk

Stadol
    Dosage: unk

Morphine Sulfate
    Dosage: unk



Possible Tofranil side effects in 41 year old female

Reported by a pharmacist from United States on 2012-07-27

Patient: 41 year old female, weighing 75.2 kg (165.4 pounds)

Reactions: Dysarthria, Somnolence, Accidental Overdose

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine
    Dosage: chronic
    Indication: Back Pain

Dilaudid
    Dosage: chronic
    Indication: Back Pain

Klonopin
    Dosage: chronic
    Indication: Back Pain

Diazepam
    Dosage: chronic
    Indication: Back Pain

Fentanyl
    Dosage: chronic
    Indication: Back Pain

Tramadol HCL
    Dosage: chronic
    Indication: Back Pain

Lorazepam
    Dosage: chronic
    Indication: Back Pain

Tofranil
    Dosage: chronic
    Indication: Back Pain

Other drugs received by patient: Synthroid; Lotemax; Prednisone TAB; Reglan; Depakote; Restasis; Seasonale; Zofran; Colace



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-11

Patient: female

Reactions: Confusional State, Agitation, Nightmare, Drug Ineffective, Hyperglycaemia, Toxicity To Various Agents, Rash, Convulsion, Tremor, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Tegretol

Requip

Neurontin

Darvocet-N 50

Remeron

Reglan

Depakote

Imitrex

Zonegran

Erythromycin

Ritalin

Sinequan

Elavil

Adderall 5

Wellbutrin

Pamelor

Prozac

Buspar

Lunesta

Trileptal

Topamax

Beta Blocking Agents

Abilify

Valium
    Indication: Agitation

Steroids NOS

Seroquel

MAO Inhibitors

Tofranil

Zoloft

Paxil

Daytrana

Effexor

Skelaxin

Antidepressants

Tizanidine Hydrochloride

Desyrel

Zyprexa

Other drugs received by patient: Vitamin B-Complex, Other Combinations; Caltrate +D; Ensure; ONE A DAY; Aspirin



Possible Tofranil side effects in female

Reported by a physician from United States on 2012-06-22

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Butazolidin Alka
    Dosage: unk

Tofranil
    Dosage: unk

Stadol
    Dosage: unk

Morphine Sulfate
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Limbitrol
    Dosage: unk

Pseudoephedrine HCL
    Dosage: unk



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-06-18

Patient: female

Reactions: Urinary Tract Infection, Condition Aggravated

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tegretol
    Dosage: 200 mg, a day for 4 years
    Administration route: Oral
    Start date: 2008-01-01

Tofranil
    Dosage: 1 df, tid
    Administration route: Oral
    Indication: Dizziness

Tegretol
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Ischaemia

Tofranil
    Dosage: 75 mg, a day for 10 years
    Administration route: Oral



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from Brazil on 2012-06-13

Patient: female

Reactions: Death, Urinary Tract Infection

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Tegretol
    Dosage: 1 df, qd
    Administration route: Oral
    Indication: Nervous System Disorder

Tofranil
    Dosage: 1 df, tid
    Administration route: Oral
    Indication: Nervous System Disorder



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female

Reactions: Agitation, Confusional State, Nightmare, Drug Ineffective, Hyperglycaemia, Rash, Toxicity To Various Agents, Tremor, Convulsion, Weight Increased, Bipolar Disorder, Chest Pain

Drug(s) suspected as cause:
Skelaxin

Elavil

Prozac

Reglan

Tegretol

Depakote

Steroids NOS

Zonegran

MAO Inhibitors

Pamelor

Paxil

Requip

Sinequan

Abilify

Remeron

Tofranil

Buspar

Topamax

Imitrex

Darvocet-N 50

Seroquel

Tizanidine Hydrochloride

Adderall 5

Neurontin

Beta Blocking Agents

Desyrel

Zoloft

Ritalin

Trileptal

Valium
    Indication: Agitation

Lunesta

Daytrana

Erythromycin

Effexor

Antidepressants

Wellbutrin

Zyprexa

Other drugs received by patient: Aspirin; Caltrate +D; ONE A DAY; Vitamin B-Complex, Other Combinations; Ensure



Possible Tofranil side effects in female

Reported by a physician from Japan on 2012-06-07

Patient: female

Reactions: Mania

Drug(s) suspected as cause:
Lamictal
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-04-17

Lamictal
    Dosage: 25mg alternate days
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-04
    End date: 2012-02-07

Lamictal
    Dosage: 25mg per day
    Administration route: Oral
    Start date: 2012-02-08
    End date: 2012-02-28

Lamictal
    Dosage: 50mg per day
    Administration route: Oral
    Start date: 2012-02-29
    End date: 2012-03-27

Depakene
    Dosage: 800mg per day
    Administration route: Oral
    Start date: 2012-04-16

Tofranil
    Dosage: 9iuax per day
    Administration route: Oral
    Indication: Depression
    Start date: 2003-01-01
    End date: 2012-04-17

Fluvoxamine Maleate
    Dosage: 3iuax per day
    Administration route: Oral
    Indication: Depression
    Start date: 2003-01-01
    End date: 2012-04-17

Depakene
    Dosage: 400mg per day
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2007-04-01
    End date: 2012-04-15



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female, weighing 75.8 kg (166.8 pounds)

Reactions: Weight Increased, Contusion

Drug(s) suspected as cause:
Tofranil
    Dosage: qhs
    Administration route: Oral
    Indication: Anxiety
    Start date: 1985-01-01

Tofranil
    Indication: Panic Attack

Other drugs received by patient: RED Yeast Rice; Aspirin; Fish OIL; Stool Softener; Clonazepam



Possible Tofranil side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-25

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Back Pain, Oral Discomfort, Product Taste Abnormal, Headache, Abdominal Pain Upper

Drug(s) suspected as cause:
Tofranil

Other drugs received by patient: Xanax



Possible Tofranil side effects in female

Reported by a physician from Japan on 2012-05-23

Patient: female

Reactions: Mania

Drug(s) suspected as cause:
Depakene
    Dosage: 400mg per day
    Administration route: Oral
    Start date: 2007-04-01
    End date: 2012-04-15

Depakene
    Dosage: 800mg per day
    Administration route: Oral
    Start date: 2012-04-16

Lamictal
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2012-03-28
    End date: 2012-04-17

Fluvoxamine Maleate
    Dosage: 3iuax per day
    Administration route: Oral
    Indication: Depression
    Start date: 2003-01-01
    End date: 2012-04-17

Tofranil
    Dosage: 9iuax per day
    Administration route: Oral
    Indication: Depression
    Start date: 2003-01-01
    End date: 2012-04-17

Lamictal
    Dosage: 25mg alternate days
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-01



Possible Tofranil side effects in female

Reported by a physician from United States on 2012-05-21

Patient: female

Reactions: Drug Hypersensitivity

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

Tofranil
    Dosage: unk

Inderal
    Dosage: unk

Paxil
    Dosage: unk

Remeron
    Dosage: unk

Desyrel
    Dosage: unk

Prozac
    Dosage: unk

Zoloft
    Dosage: unk



Possible Tofranil side effects in female

Reported by a physician from Japan on 2012-05-01

Patient: female

Reactions: Mania, Psychomotor Hyperactivity, Drug Level Increased, Logorrhoea

Drug(s) suspected as cause:
Tofranil
    Administration route: Oral
    Indication: Depression
    End date: 2012-04-16

Fluvoxamine Maleate
    Administration route: Oral
    Indication: Depression
    End date: 2012-04-16

Depakene
    Administration route: Oral
    Start date: 2012-04-16

Lamictal
    Administration route: Oral
    Indication: Bipolar Disorder
    Start date: 2012-02-01
    End date: 2012-03-28

Depakene
    Administration route: Oral
    Indication: Bipolar Disorder
    End date: 2012-04-15

Lamictal
    Dosage: 100mg per day
    Administration route: Oral
    Start date: 2012-03-29
    End date: 2012-04-16



Possible Tofranil side effects in male

Reported by a consumer/non-health professional from United States on 2012-02-06

Patient: male, weighing 102.3 kg (225.0 pounds)

Reactions: Fatigue, Tachyphrenia, Bradyphrenia, Somnolence

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

Navane
    Dosage: 5 mg, 2x/day
    Administration route: Oral
    Start date: 1982-07-01

Navane
    Dosage: 2 mg, 2x/day



Possible Tofranil side effects in 4 year old male

Reported by a consumer/non-health professional from Brazil on 2011-12-13

Patient: 4 year old male

Reactions: Accident, Confusional State, Hypersensitivity, Psychological Trauma, Aggression

Drug(s) suspected as cause:
Ritalin
    Dosage: 3 tabs, daily
    Administration route: Oral
    Indication: Psychomotor Hyperactivity

Tofranil
    Dosage: 1 tab, at night

Ritalin
    Dosage: 2 tabs, daily
    Administration route: Oral

Carbolitium
    Dosage: unk ukn, unk

Other drugs received by patient: Neozine; Risperidone



Possible Tofranil side effects in male

Reported by a physician from United States on 2011-12-12

Patient: male, weighing 89.8 kg (197.6 pounds)

Reactions: Confusional State, Chest Discomfort, Somnolence, Chronic Obstructive Pulmonary Disease, Urinary Tract Obstruction, Fatigue, Bipolar Disorder, Dyspepsia

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

Nicotrol
    Dosage: unk
    Start date: 2011-04-01
    End date: 2011-06-01

Nicotrol
    Dosage: approximately 10 times a day from mon till thurs; 4-5 times a day from fri- sun
    Start date: 2011-07-01

Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy
    Start date: 2001-01-01

Nicotrol
    Dosage: unk
    Start date: 2005-01-01

Nicotrol
    Dosage: unk
    Start date: 2002-01-01
    End date: 2003-01-01

Other drugs received by patient: Seroquel; Lovaza; Naproxen; Naproxen; Aspirin; Klonopin; Protonix; Tricor; Percocet



Possible Tofranil side effects in male

Reported by a physician from United States on 2011-12-01

Patient: male, weighing 89.8 kg (197.6 pounds)

Reactions: Confusional State, Chest Discomfort, Chronic Obstructive Pulmonary Disease, Somnolence, Urinary Tract Obstruction, Fatigue, Dyspepsia, Bipolar Disorder

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy
    Start date: 2001-01-01

Nicotrol
    Dosage: approximately 10 times a day from mon till thurs; 4-5 times a day from fri- sun
    Start date: 2011-07-01

Nicotrol
    Dosage: unk
    Start date: 2011-04-01
    End date: 2011-06-01

Nicotrol
    Dosage: unk
    Start date: 2002-01-01
    End date: 2003-01-01

Tofranil
    Dosage: unk

Nicotrol
    Dosage: unk
    Start date: 2005-01-01

Other drugs received by patient: Tricor; Protonix; Klonopin; Naproxen; Seroquel; Aspirin; Percocet; Lovaza; Naproxen



Possible Tofranil side effects in male

Reported by a consumer/non-health professional from United States on 2011-10-20

Patient: male, weighing 89.8 kg (197.6 pounds)

Reactions: Confusional State, Chest Discomfort, Chronic Obstructive Pulmonary Disease, Somnolence, Urinary Tract Obstruction, Fatigue, Dyspepsia, Bipolar Disorder

Drug(s) suspected as cause:
Nicotrol
    Dosage: unk
    Start date: 2005-01-01

Nicotrol
    Dosage: unk
    Indication: Smoking Cessation Therapy
    Start date: 2001-01-01

Nicotrol
    Dosage: unk
    Start date: 2011-04-01
    End date: 2011-06-01

Nicotrol
    Dosage: unk
    Start date: 2002-01-01
    End date: 2003-01-01

Tofranil
    Dosage: unk

Nicotrol
    Dosage: approximately 10 times a day from mon till thurs; 4-5 times a day from fri- sun
    Start date: 2011-07-01

Other drugs received by patient: Acetylsalicylic Acid; Percocet; Klonopin; Lovaza; Seroquel; Protonix; Tricor; Naproxen

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