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Infant Side Effects

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Infant Side Effects Summary

Infant FDA adverse reports: 39. View All Infant FDA Adverse Reports

Infant FDA safety alerts: 2002 2005 2006 2007 2008 2009

Reported deaths: 9

Reported hospitalizations: 14

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Infant Adverse Effect Reports (FDA)
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Infant Side Effects Report: 6991284-4,Choking, Product Quality Issue, Retching
on Aug 07, 2008 Female patient from UNITED STATES, , weighting 15.01 lb, was diagnosed with teething and was treated with Infant. After Infant was administered, patient had the following side effects: choking (What is choking?), Infant and product quality issue, retching. Infant dosage: 1.25 Ml X 1. During the same period patient was treated with ZANTAC.

Infant Side Effects Report: 6725396-7,Feeling Abnormal, Jaundice, Pyrexia, Tremor
on May 14, 2010 Male patient from UNITED STATES, , weighting 12.50 lb, was diagnosed with pain (What is pain?) and was treated with Infant. After Infant was administered, patient had the following side effects: feeling abnormal, jaundice (What is jaundice?), Infant and pyrexia, Infant and tremor. Infant dosage: 10mg/kg 4 Doses Po. During the same period patient was treated with INFANT TYLENOL CONCENTRATED.

Infant Side Effects Report: 6721193-7,Hypersomnia
on May 12, 2010 Male patient from UNITED STATES, was treated with Infant. After Infant was administered, patient had the following side effects: hypersomnia. Infant dosage: .08 One Time.

Infant Side Effects Report: 6715444-2,Diarrhoea
on May 07, 2010 Male patient from UNITED STATES, , weighting 34.00 lb, was diagnosed with ear infection (What is ear infection?), pyrexia and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and diarrhoea. Infant dosage: . During the same period patient was treated with INFANT DROPS TYLENOL, INFANT DROPS TYLENOL.


Infant Side Effects Report: 6715308-4,Diarrhoea, Pyrexia, Vomiting
on May 07, 2010 Female patient from UNITED STATES, , weighting 18.08 lb, was diagnosed with pyrexia and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and diarrhoea, Infant and pyrexia, Infant and vomiting. Infant dosage: 0.4ml 7-8 Hours. During the same period patient was treated with INFANT TYLENOL.

Infant Side Effects Report: 6710708-0,Lethargy, Product Formulation Issue, Product Quality Issue
on May 04, 2010 Female patient from UNITED STATES, , weighting 20.00 lb, was diagnosed with teething and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and lethargy, product formulation issue, Infant and product quality issue. Infant dosage: 0.8 Every 6 Hr Po.

Infant Side Effects Report: 5930646-0,Abdominal Discomfort, Blood Chloride Increased, Blood Glucose Decreased, Blood Potassium Increased, Blood Sodium Decreased, Cardiac Disorder, Decreased Appetite
on Oct 14, 2008 Male patient from UNITED STATES, , weighting 15.76 lb, was diagnosed with nasopharyngitis and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and abdominal discomfort, Infant and blood chloride increased, Infant and blood glucose decreased, Infant and blood potassium increased, Infant and blood sodium decreased, Infant and cardiac disorder, decreased appetite. Infant dosage: . During the same period patient was treated with INFANTS COLD AND COUGH PREPARTION. Patient died on 10/08/2001.

Infant Side Effects Report: 5912161-3,Incorrect Dose Administered, Roseola
on Oct 03, 2008 Male patient from UNITED STATES, , child 1 years of age, weighting 22.00 lb, was diagnosed with pyrexia, roseola and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and incorrect dose administered, roseola. Infant dosage: 200mg Q6hrs Po. During the same period patient was treated with INFANT MOTRIN.

Infant Side Effects Report: 5720570-0,Acute Hepatic Failure, Haematemesis, Incorrect Dose Administered, Lethargy
on Apr 28, 2008 Female patient from UNITED STATES, , weighting 26.46 lb, was diagnosed with upper respiratory tract infection and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and acute hepatic failure, haematemesis, Infant and incorrect dose administered, Infant and lethargy. Infant dosage: . Patient was hospitalized.


Infant Side Effects Report: 5694125-0,Cardiac Arrest, Cardiovascular Disorder, Endocrine Disorder, Gastrointestinal Injury, Hypothermia, Liver Disorder
on Mar 20, 2008 Female patient from UNITED STATES, , weighting 20.00 lb, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and cardiac arrest (What is cardiac arrest?), Infant and cardiovascular disorder, endocrine disorder, gastrointestinal injury, hypothermia (What is hypothermia?), liver disorder. Infant dosage: Oral. Patient died on 05/09/2006.

Infant Side Effects Report: 5693147-3,Condition Aggravated, Flatulence, Gastrooesophageal Reflux Disease, Infantile Spitting Up, Pain
on Apr 02, 2008 Male patient from UNITED STATES, , weighting 11.00 lb, was diagnosed with flatulence, gastrooesophageal reflux disease and was treated with Infant. After Infant was administered, patient had the following side effects: condition aggravated, flatulence, gastrooesophageal reflux disease, infantile spitting up, pain (What is pain?). Infant dosage: 0.3ml Repeated As Needed Po. During the same period patient was treated with INFANT MYLICON ANTIGAS MERCK.

Infant Side Effects Report: 5630682-8,Overdose
on Feb 01, 2008 Female patient from UNITED STATES, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and overdose. Infant dosage: Oral. Patient died on 05/09/2006.

Infant Side Effects Report: 5603974-6,Blood Disorder, Eye Haemorrhage, Mouth Haemorrhage
on Jan 24, 2008 Male patient from UNITED STATES, , weighting 16.00 lb, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and blood disorder, eye haemorrhage, mouth haemorrhage. Infant dosage: X1 Oral. During the same period patient was treated with ULTRA BRIGHT BEGINNING INFANTMULA. Patient died on 09/15/2007.

Infant Side Effects Report: 5590302-8,Agitation, Hallucination, Visual
on Dec 28, 2007 Female patient from UNITED STATES, , child 3 years of age, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and agitation, hallucination, visual. Infant dosage: 1 Dose.


Infant Side Effects Report: 5510219-4,Lip Discolouration, Peripheral Coldness, Tremor
on Nov 06, 2007 Male patient from UNITED STATES, , weighting 25.00 lb, was diagnosed with immunisation and was treated with Infant. After Infant was administered, patient had the following side effects: lip discolouration, peripheral coldness, Infant and tremor. Infant dosage: 1.6 Ml.

Infant Side Effects Report: 5481296-4,Glossodynia
on Oct 05, 2007 Female patient from UNITED STATES, , weighting 28.00 lb, was diagnosed with cough, nasopharyngitis, sinus congestion and was treated with Infant. After Infant was administered, patient had the following side effects: glossodynia. Infant dosage: 2 Strips Every 4 Hours Po. During the same period patient was treated with INFANT TRIAMINIC THIN STRIPS NOVARTIS, INFANT TRIAMINIC THIN STRIPS NOVARTIS.

Infant Side Effects Report: 5165477-5,Anoxic Encephalopathy, Loss Of Consciousness, Respiratory Arrest
on Dec 06, 2006 Male patient from UNITED STATES, , weighting 16.00 lb, was diagnosed with cough, nasopharyngitis and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and anoxic encephalopathy, loss of consciousness, respiratory arrest. Infant dosage: . During the same period patient was treated with CARBAXEFED DN RF, CARBAXEFED DN RF, PHENOBARBITAL. Patient died on 05/25/2005.

Infant Side Effects Report: 5118409-X,Irritability
on Sep 19, 2006 Male patient from UNITED STATES, , child 2 years of age, was treated with Infant. After Infant was administered, patient had the following side effects: irritability. Infant dosage: A Bottle Once, Oral.

Infant Side Effects Report: 5106909-8,Speech Disorder
on Sep 06, 2006 Female patient from UNITED STATES, , weighting 12.00 lb, was diagnosed with rhinorrhoea and was treated with Infant. After Infant was administered, patient had the following side effects: speech disorder. Infant dosage: Less Than 0.8 Ml Every 4 Hours, Oral.


Infant Side Effects Report: 5079642-9,Diarrhoea, Erythema Of Eyelid, Unevaluable Event
on Jul 31, 2006 Male patient from UNITED STATES, , weighting 15.00 lb, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and diarrhoea, erythema of eyelid, unevaluable event. Infant dosage: 2-3 Dropperfuls, Oral.

Infant Side Effects Report: 4952314-4,Somnolence
on Mar 09, 2006 Male patient from UNITED STATES, , child 1. years of age, weighting 20.00 lb, was diagnosed with accidental overdose and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and somnolence. Infant dosage: Approximately Half Of The Bottle Once, Oral.

Infant Side Effects Report: 4924030-6,Crying, Heart Rate Increased, Oral Intake Reduced
on Feb 07, 2006 Female patient from UNITED STATES, , weighting 10.00 lb, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and crying, heart rate increased, Infant and oral intake reduced. Infant dosage: 0.4 Ml Once; Oral. Patient was hospitalized.

Infant Side Effects Report: 4921571-2,Somnolence
on Feb 07, 2006 Male patient from UNITED STATES, , weighting 14.00 lb, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and somnolence. Infant dosage: Less Than 0.4 Ml Once Per Day 5-6 Times, Oral.

Infant Side Effects Report: 4921552-9,Incorrect Dose Administered, Muscle Twitching
on Feb 08, 2006 Female patient from UNITED STATES, , weighting 16.00 lb, was diagnosed with nasal congestion and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and incorrect dose administered, muscle twitching. Infant dosage: .2ml-.8ml One Time, Oral. During the same period patient was treated with SALINETURE.


Infant Side Effects Report: 4918720-9,Anorexia, Nervousness, Restlessness
on Feb 05, 2006 Female patient from UNITED STATES, , weighting 8.00 lb, was diagnosed with nasopharyngitis and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and anorexia, nervousness, restlessness. Infant dosage: 0.4 Ml Every Four Hours, Oral.

Infant Side Effects Report: 4908946-2,Crying, Oral Intake Reduced, Somnolence
on Jan 29, 2006 Male patient from UNITED STATES, , weighting 11.00 lb, was diagnosed with nasopharyngitis and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and crying, Infant and oral intake reduced, Infant and somnolence. Infant dosage: 0.4 Ml 4 Times A Day, Oral.

Infant Side Effects Report: 4905943-8,Abnormal Behaviour, Hallucination, Insomnia, Psychomotor Hyperactivity, Screaming
on Jan 27, 2006 Female patient from UNITED STATES, , weighting 20.00 lb, was diagnosed with nasal congestion and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and abnormal behaviour, hallucination, insomnia, Infant and psychomotor hyperactivity, screaming. Infant dosage: 0.4 Ml Every 6 Hours, Oral.

Infant Side Effects Report: 4898309-0,Depressed Level Of Consciousness, Somnolence
on Jan 20, 2006 Male patient from UNITED STATES, , child 2 years of age, weighting 29.00 lb, was diagnosed with cough and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and depressed level of consciousness, Infant and somnolence. Infant dosage: 2 Droppers Once, Oral.

Infant Side Effects Report: 4879910-7,Crying, Psychomotor Hyperactivity
on Jan 02, 2006 Female patient from UNITED STATES, , weighting 12.00 lb, was diagnosed with cough and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and crying, Infant and psychomotor hyperactivity. Infant dosage: 5-6 Ml Every 4 Hours, Oral. During the same period patient was treated with PARACETAMOL.


Infant Side Effects Report: 4867520-7,Emotional Disorder, Fatigue
on Dec 15, 2005 Male patient from UNITED STATES, , child 3 years of age, was diagnosed with accidental exposure and was treated with Infant. After Infant was administered, patient had the following side effects: emotional disorder, fatigue. Infant dosage: 1 (15 Ml) Bottle Once Minus 2 Dropperful, Oral.

Infant Side Effects Report: 4840138-8,Hyperhidrosis, Vomiting
on Nov 10, 2005 Female patient from UNITED STATES, , weighting 20.00 lb, was diagnosed with accidental exposure and was treated with Infant. After Infant was administered, patient had the following side effects: hyperhidrosis, Infant and vomiting. Infant dosage: About Half The Bottle Once, Oral.

Infant Side Effects Report: 4821430-X,Accidental Overdose, Incorrect Dose Administered
on Nov 04, 2005 Male patient from UNITED STATES, was treated with Infant. After Infant was administered, patient had the following side effects: Infant and accidental overdose, Infant and incorrect dose administered. Infant dosage: Suspension /drop. Patient was hospitalized.

Infant Side Effects Report: 4795817-8,Nausea
on Sep 24, 2005 Male patient from UNITED STATES, , child 2 years of age, weighting 40.00 lb, was diagnosed with accidental exposure and was treated with Infant. After Infant was administered, patient had the following side effects: nausea (What is nausea?). Infant dosage: 8 Doses (about 12 Ml) Once; Oral.

Infant Side Effects Report: 4755460-3,Fear, Respiratory Distress, Therapeutic Response Unexpected, Vomiting
on Aug 16, 2005 Male patient from UNITED STATES, , weighting 12.00 lb, was diagnosed with rhinorrhoea and was treated with Infant. After Infant was administered, patient had the following side effects: fear, respiratory distress, therapeutic response unexpected, Infant and vomiting. Infant dosage: 1/8 Tsp Three Times, Oral. During the same period patient was treated with LANSOPRAZOLE.


Infant Side Effects Report: 4731300-3,Dyspnoea, Wheezing
on Jul 20, 2005 Female patient from UNITED STATES, , weighting 36.00 lb, was diagnosed with cough and was treated with Infant. After Infant was administered, patient had the following side effects: dyspnoea, wheezing. Infant dosage: ^second Line Of Dropper^ Q4h, Oral.

Infant Side Effects Report: 4684491-7,Blepharospasm, Cerebral Ischaemia, Depressed Level Of Consciousness, Eye Disorder, Oxygen Saturation Decreased
on May 24, 2005 Male patient from , was diagnosed with cough and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and blepharospasm, cerebral ischaemia, Infant and depressed level of consciousness, eye disorder, oxygen saturation decreased. Infant dosage: 0.4 Ml Prn, Oral.

Infant Side Effects Report: 4606707-5,Cardiac Disorder, Cyanosis
on Mar 02, 2005 Male patient from , , weighting 8.00 lb, was diagnosed with cough and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and cardiac disorder, cyanosis. Infant dosage: 0.4 Ml 3-4 Tmes, Oral. During the same period patient was treated with CHLORIDE. Patient was hospitalized.

Infant Side Effects Report: 4575891-4,Cardiac Disorder, Cardiac Failure, Supraventricular Tachycardia
on Jan 24, 2005 Male patient from , was diagnosed with nasal congestion and was treated with Infant. After Infant was administered, patient had the following side effects: Infant and cardiac disorder, Infant and cardiac failure, supraventricular tachycardia. Infant dosage: Nasal Congestion. Patient was hospitalized.

Infant Side Effects Report: 4546697-7,Pneumonia
on Dec 25, 2004 Male patient from , was diagnosed with nasopharyngitis and was treated with Infant. After Infant was administered, patient had the following side effects: pneumonia (What is pneumonia?). Infant dosage: 2 Dropperfuls Every 3 1/2 To 4 Hours, Oral. Patient was hospitalized.


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Infant Side Effects
Infant and Abdominal discomfort
Infant and Abnormal behaviour
Infant and Accidental death
Infant and Accidental overdose
Infant and Acute hepatic failure
Infant and Agitation
Infant and Anorexia
Infant and Anoxic encephalopathy
Infant and Blepharospasm
Infant and Blood chloride increased
Infant and Blood disorder
Infant and Blood glucose decreased
Infant and Blood potassium increased
Infant and Blood sodium decreased
Infant and Cardiac arrestWhat is Cardiac arrest?
Infant and Cardiac disorder
Infant and Cardiac failure
Infant and Cardiovascular disorder
Infant and Crying
Infant and Depressed level of consciousness
Infant and Diarrhoea
Infant and Incorrect dose administered
Infant and Lethargy
Infant and Oral intake reduced
Infant and Product quality issue
Infant and Psychomotor hyperactivity
Infant and Pyrexia
Infant and Somnolence
Infant and Tremor
Infant and Vomiting

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