ADVERSE REACTIONS
Note – Although the listing which follows includes a few adverse reactions which have not been reported with this specific drug, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when Tofranil is administered.
Cardiovascular: Orthostatic hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, ECG changes, precipitation of congestive heart failure, stroke.
Psychiatric: Confusional states (especially in the elderly) with hallucinations, disorientation, delusions; anxiety, restlessness, agitation; insomnia and nightmares; hypomania; exacerbation of psychosis.
Neurological: Numbness, tingling, paresthesias of extremities; incoordination, ataxia, tremors; peripheral neuropathy; extrapyramidal symptoms; seizures, alterations in EEG patterns; tinnitus.
Anticholinergic: Dry mouth, and, rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis; constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract.
Allergic: Skin rash, petechiae, urticaria, itching, photosensitization; edema (general or of face and tongue); drug fever; cross-sensitivity with desipramine.
Hematologic: Bone marrow depression including agranulocytosis; eosinophilia; purpura; thrombocytopenia.
Gastrointestinal: Nausea and vomiting, anorexia, epigastric distress, diarrhea; peculiar taste, stomatitis, abdominal cramps, black tongue.
Endocrine: Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels; inappropriate antidiuretic hormone (ADH) secretion syndrome.
Other: Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness and fatigue; headache; parotid swelling; alopecia; proneness to falling.
Withdrawal Symptoms: Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
Note – In enuretic children treated with Tofranil the most common adverse reactions have been nervousness, sleep disorders, tiredness, and mild gastrointestinal disturbances. These usually disappear during continued drug administration or when dosage is decreased. Other reactions which have been reported include constipation, convulsions, anxiety, emotional instability, syncope, and collapse. All of the adverse effects reported with adult use should be considered.
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REPORTS OF SUSPECTED TOFRANIL SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Tofranil. The information is not vetted and should not be considered as verified clinical evidence.
Possible Tofranil side effects / adverse reactions 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
Suspect drug(s):
Carbolitium
Dosage: unk ukn, unk
Ritalin
Dosage: 3 tabs, daily
Administration route: Oral
Indication: Psychomotor Hyperactivity
Ritalin
Dosage: 2 tabs, daily
Administration route: Oral
Tofranil
Dosage: 1 tab, at night
Other drugs received by patient: Neozine; Risperidone
Possible Tofranil side effects / adverse reactions 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
Suspect drug(s):
Diazepam
Dosage: chronic
Indication: Back Pain
Dilaudid
Dosage: chronic
Indication: Back Pain
Fentanyl
Dosage: chronic
Indication: Back Pain
Klonopin
Dosage: chronic
Indication: Back Pain
Lorazepam
Dosage: chronic
Indication: Back Pain
Morphine
Dosage: chronic
Indication: Back Pain
Tofranil
Dosage: chronic
Indication: Back Pain
Tramadol HCL
Dosage: chronic
Indication: Back Pain
Other drugs received by patient: Synthroid; Lotemax; Prednisone TAB; Reglan; Depakote; Restasis; Seasonale; Zofran; Colace
Possible Tofranil side effects / adverse reactions 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
Suspect drug(s):
Butazolidin Alka
Dosage: unk
Codeine Sulfate
Dosage: unk
Limbitrol
Dosage: unk
Morphine Sulfate
Dosage: unk
Pseudoephedrine HCL
Dosage: unk
Stadol
Dosage: unk
Tofranil
Dosage: unk
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