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Tussionex Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 51 

Pharyngeal Oedema (6162966-1)
on Apr 03, 2009 Female from UNITED STATES , 41 years of age, was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: pharyngeal oedema. Tussionex dosage: N/A.

Blood Pressure Increased, Colitis, Heart Rate Increased (6110855-0)
Patient was taking Tussionex. Patient felt the following Tussionex side effects: blood pressure increased, colitis, heart rate increased on Feb 20, 2009 from UNITED STATES Additional patient health information: Male , 64 years of age, weighting 151.9 lb, was diagnosed with
  • cough
and. Tussionex dosage: 1 Df 2/d Po.
Multiple prescriptions taken:
  • Metformin Hcl
  • Avelox
Patient was hospitalized.

Bronchitis, Candidiasis, Choking, Pneumonia, Sinusitis (6065749-6)
Adverse event was reported on Jan 15, 2009 by a Female taking Tussionex (Dosage: 5 Ml 2/d Po) was diagnosed with
  • cough
and. Location: UNITED STATES , 67 years of age, weighting 178.4 lb, After Tussionex was administered, patient encountered several Tussionex side effects: bronchitis, candidiasis, choking, pneumonia, sinusitis.
Multiple concurrent drugs taken:
  • Cymbalta
  • Benicar
  • Ambien Cr
  • Spironolactone
  • Prevacid
  • Lovaza
  • Vitamin D
  • Flax Oil
Patient was hospitalized.

Anaphylactic Reaction (5988368-6)
on Nov 18, 2008 Female from UNITED STATES , 44 years of age, weighting 179.9 lb, was diagnosed with
  • cough
and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: anaphylactic reaction. Tussionex dosage: 2/d Po.


Cough, Dizziness, Feeling Abnormal, Incorrect Dose Administered, Insomnia, Sluggishness, Somnolence (5976627-2)
on Dec 01, 2008 Female from UNITED STATES , 37 years of age, weighting 125.0 lb, was diagnosed with
  • bronchitis
and was treated with Tussionex. Patient felt the following Tussionex side effects: cough, dizziness, feeling abnormal, incorrect dose administered, insomnia, sluggishness, somnolence. Tussionex dosage: 5ml.

Face Oedema, Oedema Peripheral, Poisoning, Rash, Urticaria (5894482-6)
Patient was taking Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: face oedema, oedema peripheral, poisoning, rash, urticaria on Sep 04, 2008 from UNITED STATES Additional patient health information: Female , 19 years of age, weighting 122.2 lb, was diagnosed with
  • bronchitis
  • cough
and. Tussionex dosage: 5 Ml /d Po.

Face Oedema, Oedema Peripheral, Pruritus, Urticaria (5842648-3)
Adverse event was reported on Jul 23, 2008 by a Female taking Tussionex (Dosage: 5 Ml /d Po) was diagnosed with
  • bronchitis
  • cough
and. Location: UNITED STATES , 19 years of age, weighting 122.2 lb, Directly after, patient experienced the unwanted or unexpected Tussionex side effects: face oedema, oedema peripheral, pruritus, urticaria.

Benign Neoplasm, Blood Pressure Increased, Fall, Headache, Loss Of Consciousness, Renal Failure (5825173-5)
on Jul 07, 2008 Male from UNITED STATES , 62 years of age, weighting 189.5 lb, was diagnosed with
  • postnasal drip
and was treated with Tussionex. Patient felt the following Tussionex side effects: benign neoplasm, blood pressure increased, fall, headache, loss of consciousness, renal failure. Tussionex dosage: 2/d Po. Patient was hospitalized.

Chest Pain, Dyspnoea (5819715-3)
on Jul 01, 2008 Male from UNITED STATES , 46 years of age, weighting 165.3 lb, was diagnosed with
  • cough
and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: chest pain, dyspnoea. Tussionex dosage: 5 Ml 2/d Po.
Multiple concurrent drugs taken:
  • Ativan
Patient was hospitalized.

(5787725-0)
Patient was taking Tussionex. on Jun 24, 2008 from UNITED STATES Additional patient health information: Male , child 3 years of age, weighting 32.00 lb, was diagnosed with
  • viral upper respiratory tract infection
and. Tussionex dosage: N/A.

Oedema Peripheral, Urticaria (5621558-0)
Adverse event was reported on Jan 22, 2008 by a Female taking Tussionex (Dosage: 5 Ml /d Po) was diagnosed with
  • cough
and. Location: UNITED STATES , 19 years of age, Patient felt the following Tussionex side effects: oedema peripheral, urticaria.
Multiple prescriptions taken:
  • Advair Diskus 100/50
  • Clindamycin Hcl


Blood Glucose Increased (5501347-8)
on Oct 10, 2007 Male from UNITED STATES , 80 years of age, was diagnosed with
  • cough
and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: blood glucose increased. Tussionex dosage: 10 Mg 2/d Po.

(5405920-7)
on Jul 17, 2007 Female from UNITED STATES , 52 years of age, was treated with Tussionex. . Tussionex dosage: N/A.

Accidental Overdose, Alcohol Use, Bronchopneumonia, Choking, Pulmonary Congestion, Pulmonary Oedema (5323065-1)
Patient was taking Tussionex. Patient felt the following Tussionex side effects: accidental overdose, alcohol use, bronchopneumonia, choking, pulmonary congestion, pulmonary oedema on Apr 20, 2007 from UNITED STATES Additional patient health information: Male , 21 years of age, . Tussionex dosage: N/A.

Accidental Overdose, Brain Oedema, Pulmonary Congestion, Pulmonary Oedema (5323055-9)
Adverse event was reported on Apr 20, 2007 by a Male taking Tussionex (Dosage: N/A) . Location: UNITED STATES , 23 years of age, After Tussionex was administered, patient encountered several Tussionex side effects: accidental overdose, brain oedema, pulmonary congestion, pulmonary oedema.

Conversion Disorder, Paralysis, Vision Blurred (5147298-2)
on Oct 18, 2006 Female from UNITED STATES , 44 years of age, was diagnosed with
  • bronchitis
and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: conversion disorder, paralysis, vision blurred. Tussionex dosage: N/A.
Associated medications used:
  • Levaquin
Patient was hospitalized.

Cardio-respiratory Arrest, Overdose, Respiratory Depression (5084308-5)
on Jul 31, 2006 Male from UNITED STATES , child 6 years of age, was diagnosed with
  • cough
and was treated with Tussionex. Patient felt the following Tussionex side effects: cardio-respiratory arrest, overdose, respiratory depression. Tussionex dosage: 2.5 Ml 2/d Po.
Multiple prescriptions taken:
  • Azithromax (Po)


Arrhythmia, Cardiac Disorder, Hypertrophy, Pericarditis, Pulmonary Congestion, Pulmonary Oedema, Viral Infection (5079203-1)
Patient was taking Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: arrhythmia, cardiac disorder, hypertrophy, pericarditis, pulmonary congestion, pulmonary oedema, viral infection on Jul 24, 2006 from UNITED STATES Additional patient health information: Female , child 11 years of age, was diagnosed with
  • cough
and. Tussionex dosage: Once Po.
Multiple concurrent drugs taken:
  • Zithromax (Po)


Abdominal Pain Upper, Vomiting (5063824-6)
Adverse event was reported on Jul 26, 2006 by a Female taking Tussionex (Dosage: 1 Tsp X1 Dose Oral [one Dose Only]) was diagnosed with
  • cough
and. Location: UNITED STATES , 53 years of age, weighting 140.0 lb, Directly after, patient experienced the unwanted or unexpected Tussionex side effects: abdominal pain upper, vomiting.

Cardio-respiratory Arrest, Loss Of Consciousness, Overdose, Respiratory Depression (5046492-9)
on Jun 15, 2006 Male from UNITED STATES , child 6 years of age, was diagnosed with
  • cough
and was treated with Tussionex. Patient felt the following Tussionex side effects: cardio-respiratory arrest, loss of consciousness, overdose, respiratory depression. Tussionex dosage: 2.5 Ml 2/d Po.
Multiple prescriptions taken:
  • Azithromax (Po)


Overdose (5028338-8)
on May 25, 2006 Male from UNITED STATES , child 6 years of age, was diagnosed with
  • cough
and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: overdose. Tussionex dosage: 2.5 Ml 2/d Po.
Multiple concurrent drugs taken:
  • .
  • Azithromax (Po)


(5028337-6)
Patient was taking Tussionex. on May 25, 2006 from UNITED STATES Additional patient health information: Female , child 11 years of age, was diagnosed with
  • cough
and. Tussionex dosage: Once Po.
Associated medications used:
  • Zithromax (Po)


Incorrect Dose Administered (4989327-2)
Adverse event was reported on Apr 17, 2006 by a Female taking Tussionex (Dosage: Once Po) was diagnosed with
  • cough
and. Location: UNITED STATES , child 11 years of age, Patient felt the following Tussionex side effects: incorrect dose administered.
Multiple prescriptions taken:
  • Zithromax (Po)


Overdose (4989324-7)
on Apr 14, 2006 Male from UNITED STATES , child 6 years of age, was diagnosed with
  • cough
and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: overdose. Tussionex dosage: 2.5 Ml 2/d Po.
Multiple concurrent drugs taken:
  • Azithromax (Po)


Asthenia, Bladder Disorder, Chest Pain, Coronary Artery Atherosclerosis, Dyspepsia, Emotional Distress, Gastric Ulcer, Hypertension, Left Ventricular Failure (4680490-X)
on May 09, 2005 Female from , 61 years of age, weighting 169.8 lb, was treated with Tussionex (chlorpheniramine Polistirex (+) Hydrocodone Polistirex). Directly after, patient experienced the unwanted or unexpected Tussionex side effects: asthenia, bladder disorder, chest pain, coronary artery atherosclerosis, dyspepsia, emotional distress, gastric ulcer, hypertension, left ventricular failure. Tussionex (chlorpheniramine Polistirex (+) Hydrocodone Polistirex) dosage: N/A.
Associated medications used:
  • Zithromax
  • Ecotrin
  • Folic Acid
  • Prilosec
  • Vioxx
  • Vioxx
  • Vioxx
  • Monopril
Patient was hospitalized.

Showing 1-25 of 51 

Tussionex Health Episodes

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Tussionex Information

Alternative TUSSIONEX Names:HYDROCODO

Active Ingredient: CHLORPHEN

More About Tussionex

Side Effects reported to FDA: 51. View Tussionex Adverse Reports

Tussionex safety alerts: 2008

Reported deaths: 20

Reported hospitalizations: 17

Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)

Audience: Healthcare professionals, pharmacists, patients

[UPDATE 04/24/2008] Dear Healthcare Professional Letter issued by UCB, Inc.

[Posted 03/11/2008] FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.

Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.

[April 16, 2008 - Dear Healthcare Provider Letter - UCB]
[March 11, 2008 - Drug Information Page - FDA]
[March 11, 2008 - Public Health Advisory - FDA]
[January 2008 - Prescribing Information - UCB]

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