Infant Side Effects summary

Total Infant reports: 33. View

Infant FDA safety alerts: 2002 2005 2006 2007 2008 2009 .

Reported deaths: 8

Reported hospitalizations: 6.

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Recently reported Infant Side Effects


Common Infant Side Effects
Incorrect dose administered 12%
Somnolence 12%
Cardiac disorder 9%
Crying 9%
Depressed level of consciousness 6%
Oral intake reduced 6%
Psychomotor hyperactivity 6%
Vomiting 6%
Abdominal discomfort 3%
Abnormal behaviour 3%
Accidental death 3%
Accidental overdose 3%
Acute hepatic failure 3%
Agitation 3%
Anorexia 3%
Anoxic encephalopathy 3%
Blepharospasm 3%
Blood chloride increased 3%
Blood disorder 3%
Blood glucose decreased 3%
Blood potassium increased 3%
Blood sodium decreased 3%
Cardiac arrest  What is  Cardiac arrest                                                                                                                                                                                          3%
Cardiac failure 3%
Cardiovascular disorder 3%
Cell death 3%
Cerebral ischaemia 3%
Condition aggravated 3%
Cyanosis 3%
Decreased appetite 3%
Diarrhoea 3%
Dyspnoea 3%
Emotional disorder 3%
Endocrine disorder 3%
Erythema of eyelid 3%
Eye disorder 3%
Eye haemorrhage 3%
Fatigue 3%
Fear 3%
Flatulence 3%
Gastrointestinal injury 3%
Gastrooesophageal reflux disease 3%
Glossodynia 3%
Haematemesis 3%
Hallucination 3%
Hallucination, visual 3%
Heart rate increased 3%
Hyperhidrosis 3%
Hypothermia  What is  Hypothermia                                                                                                                                                                                             3%
Infantile spitting up 3%
Injury 3%
Insomnia 3%
Irritability 3%
Lethargy 3%
Lip discolouration 3%
Liver disorder 3%
Loss of consciousness 3%
Mouth haemorrhage 3%
Muscle twitching 3%
Nausea  What is  Nausea                                                                                                                                                                                                  3%
Nervousness 3%
Overdose 3%
Oxygen saturation decreased 3%
Pain  What is  Pain                                                                                                                                                                                                    3%
Peripheral coldness 3%
Pneumonia  What is  Pneumonia                                                                                                                                                                                               3%
Respiratory arrest 3%
Respiratory distress 3%
Restlessness 3%
Roseola 3%
Screaming 3%
Speech disorder 3%
Supraventricular tachycardia 3%
Therapeutic response unexpected 3%
Tremor 3%
Unevaluable event 3%
Wheezing 3%

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Infant Side Effects reported on Patientsville.com

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Infant Side Effects reported to FDA

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Infant Side Effects Report #5079642-9
Consumer or non-health professional from UNITED STATES reported Infant side effect on July 31, 2006. Male patient, weighting 15.00 lb, was treated with Infant. After drug was administered, patient experienced the following side effects: diarrhoea, erythema of eyelid, unevaluable event. Infant dosage: unknown. Patient recovered.



Infant Side Effects Report #5106909-8
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Sept 06, 2006. Female patient, weighting 12.00 lb, was diagnosed with rhinorrhoea and was treated with Infant. After drug was administered, patient experienced the following side effects: speech disorder. Infant dosage: LESS THAN 0.8 ML EVERY 4 HOURS, ORAL. Patient recovered.



Infant Side Effects Report #5118409-X
Consumer or non-health professional from UNITED STATES reported Infant side effect on Sept 19, 2006. Male patient, child 2 years of age, was treated with Infant. After drug was administered, patient experienced the following side effects: irritability. Infant dosage: unknown. Patient recovered.



Infant Side Effects Report #5165477-5
Infant side effect was reported by a Physician from UNITED STATES on Dec 06, 2006. Male patient, weighting 16.00 lb, was diagnosed with cough, nasopharyngitis and was treated with Infant. After drug was administered, patient experienced the following side effects: anoxic encephalopathy, loss of consciousness, respiratory arrest. Infant dosage: unknown. 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 #5481296-4
Consumer or non-health professional from UNITED STATES reported Infant side effect on Oct 05, 2007. Female patient, weighting 28.00 lb, was diagnosed with cough, nasopharyngitis, sinus congestion and was treated with Infant. After drug was administered, patient experienced the following side effects: glossodynia. Infant dosage: unknown. During the same period patient was treated with INFANT TRIAMINIC THIN STRIPS NOVARTIS, INFANT TRIAMINIC THIN STRIPS NOVARTIS. Patient recovered.



Infant Side Effects Report #5510219-4
Infant side effect was reported by a Physician from UNITED STATES on Nov 06, 2007. Male patient, weighting 25.00 lb, was diagnosed with immunisation and was treated with Infant. After drug was administered, patient experienced the following side effects: lip discolouration, peripheral coldness, tremor. Infant dosage: 1.6 ML. Patient recovered.



Infant Side Effects Report #5590302-8
Health Professional from UNITED STATES reported Infant side effect on Dec 28, 2007. Female patient, child 3 years of age, was treated with Infant. After drug was administered, patient experienced the following side effects: agitation, hallucination, visual. Infant dosage: unknown. Patient recovered.



Infant Side Effects Report #5603974-6
Infant side effect was reported by a Health Professional from UNITED STATES on Jan 24, 2008. Male patient, weighting 16.00 lb, was treated with Infant. After drug was administered, patient experienced the following side effects: blood disorder, eye haemorrhage, mouth haemorrhage. Infant dosage: unknown. During the same period patient was treated with ULTRA BRIGHT BEGINNING INFANTMULA. Patient died on 09/15/2007.



Infant Side Effects Report #5630682-8
Consumer or non-health professional from UNITED STATES reported Infant side effect on Feb 01, 2008. Female patient was treated with Infant. After drug was administered, patient experienced the following side effects: overdose. Infant dosage: unknown. Patient died on 05/09/2006.




Infant Side Effects Report #5693147-3
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Apr 02, 2008. Male patient, weighting 11.00 lb, was diagnosed with flatulence, gastrooesophageal reflux disease and was treated with Infant. After drug was administered, patient experienced 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. Patient recovered.



Infant Side Effects Report #5694125-0
Consumer or non-health professional from UNITED STATES reported Infant side effect on Mar 20, 2008. Female patient, weighting 20.00 lb, was treated with Infant. After drug was administered, patient experienced the following side effects: cardiac arrest What is  cardiac arrest, cardiovascular disorder, endocrine disorder, gastrointestinal injury, hypothermia What is  hypothermia, liver disorder. Infant dosage: unknown. Patient died on 05/09/2006.



Infant Side Effects Report #5720570-0
Infant side effect was reported by a Pharmacist from UNITED STATES on Apr 28, 2008. Female patient, weighting 26.46 lb, was diagnosed with upper respiratory tract infection and was treated with Infant. After drug was administered, patient experienced the following side effects: acute hepatic failure, haematemesis, incorrect dose administered, lethargy. Infant dosage: unknown. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #5912161-3
Health Professional from UNITED STATES reported Infant side effect on Oct 03, 2008. Male patient, child 1 years of age, weighting 22.00 lb, was diagnosed with pyrexia, roseola and was treated with Infant. After drug was administered, patient experienced the following side effects: incorrect dose administered, roseola. Infant dosage: 200MG Q6HRS PO. During the same period patient was treated with INFANT MOTRIN. Patient recovered.



Infant Side Effects Report #5930646-0
Infant side effect was reported by a Health Professional from UNITED STATES on Oct 14, 2008. Male patient, weighting 15.76 lb, was diagnosed with nasopharyngitis and was treated with Infant. After drug was administered, patient experienced the following side effects: abdominal discomfort, blood chloride increased, blood glucose decreased, blood potassium increased, blood sodium decreased, cardiac disorder, decreased appetite. Infant dosage: unknown. During the same period patient was treated with INFANTS COLD AND COUGH PREPARTION. Patient died on 10/08/2001.




Infant Side Effects Report #4546697-7
Consumer or non-health professional from reported Infant side effect on Dec 25, 2004. Male patient was diagnosed with nasopharyngitis and was treated with Infant. After drug was administered, patient experienced the following side effects: pneumonia What is  pneumonia. Infant dosage: unknown. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #4575891-4
Infant side effect was reported by a Consumer or non-health professional from on Jan 24, 2005. Male patient was diagnosed with nasal congestion and was treated with Infant. After drug was administered, patient experienced the following side effects: cardiac disorder, cardiac failure, supraventricular tachycardia. Infant dosage: unknown. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #4606707-5
Consumer or non-health professional from reported Infant side effect on Mar 02, 2005. Male patient, weighting 8.00 lb, was diagnosed with cough and was treated with Infant. After drug was administered, patient experienced the following side effects: cardiac disorder, cyanosis. Infant dosage: 0.4 ML 3-4 TMES, ORAL. During the same period patient was treated with CHLORIDE. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #4684491-7
Infant side effect was reported by a Consumer or non-health professional from on May 24, 2005. Male patient was diagnosed with cough and was treated with Infant. After drug was administered, patient experienced the following side effects: blepharospasm, cerebral ischaemia, depressed level of consciousness, eye disorder, oxygen saturation decreased. Infant dosage: 0.4 ML PRN, ORAL. Patient recovered.



Infant Side Effects Report #4731300-3
Consumer or non-health professional from UNITED STATES reported Infant side effect on July 20, 2005. Female patient, weighting 36.00 lb, was diagnosed with cough and was treated with Infant. After drug was administered, patient experienced the following side effects: dyspnoea, wheezing. Infant dosage: unknown. Patient recovered.




Infant Side Effects Report #4755460-3
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Aug 16, 2005. Male patient, weighting 12.00 lb, was diagnosed with rhinorrhoea and was treated with Infant. After drug was administered, patient experienced the following side effects: fear, respiratory distress, therapeutic response unexpected, vomiting. Infant dosage: unknown. During the same period patient was treated with LANSOPRAZOLE. Patient recovered.



Infant Side Effects Report #4795817-8
Consumer or non-health professional from UNITED STATES reported Infant side effect on Sept 24, 2005. Male patient, child 2 years of age, weighting 40.00 lb, was diagnosed with accidental exposure and was treated with Infant. After drug was administered, patient experienced the following side effects: nausea What is  nausea. Infant dosage: 8 DOSES (ABOUT 12 ML) ONCE; ORAL. Patient recovered.



Infant Side Effects Report #4821430-X
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Nov 04, 2005. Male patient was treated with Infant. After drug was administered, patient experienced the following side effects: accidental overdose, incorrect dose administered. Infant dosage: unknown. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #4840138-8
Consumer or non-health professional from UNITED STATES reported Infant side effect on Nov 10, 2005. Female patient, weighting 20.00 lb, was diagnosed with accidental exposure and was treated with Infant. After drug was administered, patient experienced the following side effects: hyperhidrosis, vomiting. Infant dosage: unknown. Patient recovered.



Infant Side Effects Report #4867520-7
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Dec 15, 2005. Male patient, child 3 years of age, was diagnosed with accidental exposure and was treated with Infant. After drug was administered, patient experienced the following side effects: emotional disorder, fatigue. Infant dosage: 1 (15 ML) BOTTLE ONCE MINUS 2 DROPPERFUL, ORAL. Patient recovered.




Infant Side Effects Report #4879910-7
Consumer or non-health professional from UNITED STATES reported Infant side effect on Jan 02, 2006. Female patient, weighting 12.00 lb, was diagnosed with cough and was treated with Infant. After drug was administered, patient experienced the following side effects: crying, psychomotor hyperactivity. Infant dosage: 5-6 ML EVERY 4 HOURS, ORAL. During the same period patient was treated with PARACETAMOL. Patient recovered.



Infant Side Effects Report #4898309-0
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 20, 2006. Male patient, child 2 years of age, weighting 29.00 lb, was diagnosed with cough and was treated with Infant. After drug was administered, patient experienced the following side effects: depressed level of consciousness, somnolence. Infant dosage: unknown. Patient recovered.



Infant Side Effects Report #4905943-8
Consumer or non-health professional from UNITED STATES reported Infant side effect on Jan 27, 2006. Female patient, weighting 20.00 lb, was diagnosed with nasal congestion and was treated with Infant. After drug was administered, patient experienced the following side effects: abnormal behaviour, hallucination, insomnia, psychomotor hyperactivity, screaming. Infant dosage: 0.4 ML EVERY 6 HOURS, ORAL. Patient recovered.



Infant Side Effects Report #4908946-2
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Jan 29, 2006. Male patient, weighting 11.00 lb, was diagnosed with nasopharyngitis and was treated with Infant. After drug was administered, patient experienced the following side effects: crying, oral intake reduced, somnolence. Infant dosage: 0.4 ML 4 TIMES A DAY, ORAL. Patient recovered.



Infant Side Effects Report #4918720-9
Consumer or non-health professional from UNITED STATES reported Infant side effect on Feb 05, 2006. Female patient, weighting 8.00 lb, was diagnosed with nasopharyngitis and was treated with Infant. After drug was administered, patient experienced the following side effects: anorexia, nervousness, restlessness. Infant dosage: 0.4 ML EVERY FOUR HOURS, ORAL. Patient recovered.




Infant Side Effects Report #4921552-9
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Feb 08, 2006. Female patient, weighting 16.00 lb, was diagnosed with nasal congestion and was treated with Infant. After drug was administered, patient experienced the following side effects: incorrect dose administered, muscle twitching. Infant dosage: .2ML-.8ML ONE TIME, ORAL. During the same period patient was treated with SALINETURE. Patient recovered.



Infant Side Effects Report #4921571-2
Consumer or non-health professional from UNITED STATES reported Infant side effect on Feb 07, 2006. Male patient, weighting 14.00 lb, was treated with Infant. After drug was administered, patient experienced the following side effects: somnolence. Infant dosage: LESS THAN 0.4 ML ONCE PER DAY 5-6 TIMES, ORAL. Patient recovered.



Infant Side Effects Report #4924030-6
Infant side effect was reported by a Consumer or non-health professional from UNITED STATES on Feb 07, 2006. Female patient, weighting 10.00 lb, was treated with Infant. After drug was administered, patient experienced the following side effects: crying, heart rate increased, oral intake reduced. Infant dosage: 0.4 ML ONCE; ORAL. Patient was hospitalized. Patient recovered.



Infant Side Effects Report #4952314-4
Consumer or non-health professional from UNITED STATES reported Infant side effect on Mar 09, 2006. Male patient, child 1. years of age, weighting 20.00 lb, was diagnosed with accidental overdose and was treated with Infant. After drug was administered, patient experienced the following side effects: somnolence. Infant dosage: unknown. Patient recovered.





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