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Tussionex Side Effects

Common Tussionex Side Effects

The most commonly reported Tussionex side effects (click to view or check a box to report):

Overdose (5)
Somnolence (4)
Pneumonia (4)
Accidental Overdose (4)
Death (4)
Cardio-respiratory Arrest (3)
Arrhythmia (3)
Emotional Distress (3)
Loss Of Consciousness (3)
Myocardial Infarction (3)
Incorrect Dose Administered (3)
Headache (3)
Unresponsive To Stimuli (3)
Pulmonary Oedema (3)
Pulmonary Congestion (3)
Oedema Peripheral (3)
Respiratory Depression (3)
Toxicity To Various Agents (3)
Urticaria (3)
Gastrooesophageal Reflux Disease (2)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Tussionex Side Effects Reported to FDA

The following Tussionex reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Tussionex on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Skin Ulcer, Product Formulation Issue
on Sep 17, 2013 Male from US , 33 years of age, weighting 190.0 lb, was diagnosed with and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: skin ulcer, product formulation issue. Tussionex dosage: 1 Teaspoon.
Associated medications used:
  • Tussionex Pennkinetic (1 Teaspoon)
  • Metformin
  • Multivitamin
  • Berberine
  • Triamcinolone


Accidental Overdose, Unresponsive To Stimuli, Somnolence, Ischaemic Hepatitis, Hepatic Steatosis
Patient was taking Tussionex. Patient felt the following Tussionex side effects: accidental overdose, unresponsive to stimuli, somnolence, ischaemic hepatitis, hepatic steatosis on Feb 04, 2013 from US Additional patient health information: Female , 50 years of age, weighting 145.3 lb, was diagnosed with and. Tussionex dosage: Recent Po. Patient was hospitalized.

Toxicity To Various Agents
Adverse event was reported on Jan 28, 2013 by a Female taking Tussionex (Dosage: 1 Half A Teaspoon Once A Day) was diagnosed with and. Location: US , child 4 years of age, After Tussionex was administered, patient encountered several Tussionex side effects: toxicity to various agents.
Multiple concurrent drugs taken:
  • Benadryl


Acute Pulmonary Oedema, Cardio-respiratory Arrest, Myocardial Infarction
on Feb 08, 2013 Female from US , 64 years of age, was diagnosed with and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: acute pulmonary oedema, cardio-respiratory arrest, myocardial infarction. Tussionex dosage: 5 Cc.
Associated medications used:
  • Atenolol
  • Simvastatin
  • Allegra (180 Mg)
  • Singulair
  • Edecrine
  • Edecrine
  • Qvar (Inhalation Up To 2 Puffs Daily)
  • Combivent (Inhaler Q 6-8 Hours Prn Nebulizer)



Toxicity To Various Agents
on Jun 15, 2012 Female from UNITED STATES , child 4 years of age, was treated with Tussionex. Patient felt the following Tussionex side effects: toxicity to various agents. Tussionex dosage: Oral,hal Teaspoon/day.
Multiple prescriptions taken:
  • Benadryl


Respiratory Depression, Incorrect Dose Administered, Unresponsive To Stimuli
Patient was taking Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: respiratory depression, incorrect dose administered, unresponsive to stimuli on Jun 18, 2012 from UNITED STATES Additional patient health information: Male , weighting 240.0 lb, was diagnosed with and. Tussionex dosage: 2.5 Tbl 1 Po.

Toxicity To Various Agents, Resuscitation, Unresponsive To Stimuli
Adverse event was reported on May 21, 2012 by a Female taking Tussionex (Dosage: 0.5 Tsp; Qd;) was diagnosed with and. Location: UNITED STATES , child 4 years of age, Directly after, patient experienced the unwanted or unexpected Tussionex side effects: toxicity to various agents, resuscitation, unresponsive to stimuli.
Associated medications used:
  • Diphenhydramine Hcl


Pain, Deep Vein Thrombosis, Splenic Infarction, Quality Of Life Decreased, Gallbladder Disorder, Fear, Anhedonia, Injury
on Feb 24, 2012 Female from UNITED STATES , 32 years of age, weighting 339.5 lb, was treated with Tussionex. Patient felt the following Tussionex side effects: pain, deep vein thrombosis, splenic infarction, quality of life decreased, gallbladder disorder, fear, anhedonia, injury. Tussionex dosage: N/A.
Multiple prescriptions taken:
  • Hydrocodone Bitartrate And Acetaminophen
  • Promethazine
  • Ambien (10 Mg, Unk)
  • Yasmin
  • Humibid Dm
  • Yasmin (Unk)
  • Yasmin
  • Zithromax
Patient was hospitalized.

Infusion Site Extravasation, Infusion Site Necrosis
on May 01, 2012 Female from UNITED STATES , 39 years of age, weighting 126.1 lb, was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: infusion site extravasation, infusion site necrosis. Tussionex dosage: N/A.
Multiple concurrent drugs taken:
  • Trileptal
  • Albuterol
  • Klonopin
  • Vancomycin (750mg Q12hr Ivpb Recent)
  • Atenolol
  • Topamax
  • Levothyroxine Sodium
  • Venlafaxine
Patient was hospitalized.

Anxiety, Cerebrovascular Accident
Patient was taking Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: anxiety, cerebrovascular accident on Apr 03, 2012 from UNITED STATES Additional patient health information: Female , 29 years of age, weighting 193.0 lb, . Tussionex dosage: N/A.
Associated medications used:
  • Nyquil
  • Yaz
  • Ascorbic Acid (Unk Unk, Prn)
  • Dayquil [dextromet Hbr,guaif,paracet,pseudoeph Hcl]
  • Pseudoephedrine Hcl
  • Yaz (Unk)
  • Lipitor
  • Pravastatin
Patient was hospitalized.

Sinus Disorder, Headache
Adverse event was reported on Apr 29, 2011 by a Female taking Tussionex (Dosage: (one Teaspoon Every 12 Hours Prn)) . Location: UNITED STATES , 72 years of age, Patient felt the following Tussionex side effects: sinus disorder, headache.

Emotional Distress, Pulmonary Embolism, Deep Vein Thrombosis
on Feb 15, 2012 Female from UNITED STATES , 29 years of age, weighting 138.9 lb, was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: emotional distress, pulmonary embolism, deep vein thrombosis. Tussionex dosage: N/A.
Multiple concurrent drugs taken:
  • Antimigraine Preparations
  • Augmentin '125' (875 Mg, Bid)
  • Darvocet (Unk)
  • Biaxin (Unk)
  • Levaquin (500 Mg, Qd)
  • Drospirenone And Ethinyl Estradiol (Unk Unk, Unk)
  • Drospirenone And Ethinyl Estradiol
  • Anti-asthmatics
Patient was hospitalized.

Pancreatic Carcinoma
on Feb 09, 2012 Male from UNITED STATES , weighting 165.0 lb, was diagnosed with and was treated with Tussionex Plain Elixir. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: pancreatic carcinoma. Tussionex Plain Elixir dosage: N/A.
Associated medications used:
  • Metformin Hcl
  • Lipitor
  • Tradjenta (5 Mg)


Pain, Dyspnoea, Emotional Distress, Pulmonary Embolism, Fall
Patient was taking Tussionex. Patient felt the following Tussionex side effects: pain, dyspnoea, emotional distress, pulmonary embolism, fall on Jan 04, 2012 from UNITED STATES Additional patient health information: Female , 32 years of age, weighting 250.0 lb, was diagnosed with and. Tussionex dosage: Unk.
Multiple prescriptions taken:
  • Levaquin (500 Mg, Qd)
  • Prednisone Tab (10 Mg, Unk)
  • Proair Hfa (Unk)
  • Benzonatate (4 Mg, Unk)
  • Yasmin (Unk)
  • Drospirenone And Ethinyl Estradiol (Unk)
  • Augmentin '125' (Unk)
  • Pulmicort (180 Mcg/24hr, Qd)


Anxiety, Depression, Abdominal Distension, Cholecystitis Chronic, Dyspepsia, Constipation, Flatulence, Cholecystectomy, Diarrhoea
Adverse event was reported on Nov 25, 2011 by a Female taking Tussionex (Dosage: N/A) . Location: UNITED STATES , 21 years of age, weighting 107.0 lb, After Tussionex was administered, patient encountered several Tussionex side effects: anxiety, depression, abdominal distension, cholecystitis chronic, dyspepsia, constipation, flatulence, cholecystectomy, diarrhoea.
Multiple concurrent drugs taken:
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Yaz (Unk)
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Hyoscyamine


Chronic Sinusitis, Haemorrhoids, Inflammatory Bowel Disease, Crohn's Disease, Irritable Bowel Syndrome
on Apr 15, 2011 Female from UNITED STATES , weighting 134.9 lb, was diagnosed with and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: chronic sinusitis, haemorrhoids, inflammatory bowel disease, crohn's disease, irritable bowel syndrome. Tussionex dosage: N/A.
Associated medications used:
  • Accutane
  • Amoxicillin
  • Methylprednisolone Acetate
  • Guaifen
  • Promethazine Hcl And Codeine
  • Benzonatate
Patient was hospitalized.

Left Ventricular Dysfunction, Discomfort, Scar, Metastases To Central Nervous System, Gait Disturbance, Dehydration, Bone Density Decreased, Osteoporosis, Neoplasm Recurrence
on Mar 15, 2011 Female from UNITED STATES , weighting 275.6 lb, was treated with Tussionex. Patient felt the following Tussionex side effects: left ventricular dysfunction, discomfort, scar, metastases to central nervous system, gait disturbance, dehydration, bone density decreased, osteoporosis, neoplasm recurrence. Tussionex dosage: N/A.
Multiple prescriptions taken:
  • Zofran (4 Mg / Q4h Prn)
  • Minocin
  • Activella
  • Cyclobenzaprine (10 Mg, Every 8 Hours As Needed)
  • Zometa (3.5 Mg, Qmo)
  • Paxil
  • Clindamycin
  • Megace
Patient was hospitalized.

Cholelithiasis, Cholecystectomy, Cholecystitis Chronic
Patient was taking Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: cholelithiasis, cholecystectomy, cholecystitis chronic on Feb 28, 2011 from UNITED STATES Additional patient health information: Female , weighting 99.98 lb, . Tussionex dosage: N/A.
Multiple concurrent drugs taken:
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Hyoscyamine


Dysphagia, Aphasia, Fatigue, Headache, Vitreous Floaters, Viith Nerve Paralysis, Hemiparesis, Facial Paresis, Insomnia
Adverse event was reported on Dec 01, 2010 by a Female taking Tussionex (Dosage: Unk) was diagnosed with and. Location: UNITED STATES , weighting 160.9 lb, Directly after, patient experienced the unwanted or unexpected Tussionex side effects: dysphagia, aphasia, fatigue, headache, vitreous floaters, viith nerve paralysis, hemiparesis, facial paresis, insomnia.
Associated medications used:
  • Tamiflu (75 Mg, Bid)
  • Zithromax (250 Mg, Unk)
  • Zithromax (250 Mg, Unk)
  • Tamiflu (75 Mg, Bid)
  • Robitussin A C [codeine Phosphate,guaifenesin,pheniramine Maleate] (Unk)
  • Yaz (Unk Unk, Unk)
Patient was hospitalized.

Angioedema, Dysphagia
on Jan 06, 2011 Male from UNITED STATES , 54 years of age, was diagnosed with and was treated with Tussionex. Patient felt the following Tussionex side effects: angioedema, dysphagia. Tussionex dosage: 5ml Q12h Prn Po Recent.
Multiple prescriptions taken:
  • Prednisone
  • Albuterol
  • Nystatin
  • Levaquin
Patient was hospitalized.

Gastrooesophageal Reflux Disease, Pneumonia, Pneumonia Aspiration
on Sep 07, 2010 Female from UNITED STATES , weighting 143.3 lb, was diagnosed with and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: gastrooesophageal reflux disease, pneumonia, pneumonia aspiration. Tussionex dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours Oral. Patient was hospitalized.

Contraindication To Medical Treatment
Patient was taking Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: contraindication to medical treatment on Sep 01, 2010 from UNITED STATES Additional patient health information: Patient , child 3 years of age, was diagnosed with and. Tussionex dosage: (1/2 Tsp At Bedtime Oral).

Aspiration, Gastrooesophageal Reflux Disease, Liquid Product Physical Issue, Pneumonia, Product Colour Issue, Product Taste Abnormal, Therapeutic Response Decreased
Adverse event was reported on Aug 23, 2010 by a Female taking Tussionex (Dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours, Oral) was diagnosed with and. Location: UNITED STATES , weighting 143.3 lb, Patient felt the following Tussionex side effects: aspiration, gastrooesophageal reflux disease, liquid product physical issue, pneumonia, product colour issue, product taste abnormal, therapeutic response decreased.
Multiple prescriptions taken:
  • Plavix
  • Coumadin
Patient was hospitalized.

Liquid Product Physical Issue, Pneumonia, Product Taste Abnormal, Therapeutic Response Decreased
on Aug 05, 2010 Female from UNITED STATES , weighting 143.3 lb, was diagnosed with and was treated with Tussionex. After Tussionex was administered, patient encountered several Tussionex side effects: liquid product physical issue, pneumonia, product taste abnormal, therapeutic response decreased. Tussionex dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours, Oral).
Multiple concurrent drugs taken:
  • Plavix
  • Coumadin
Patient was hospitalized.

Foetal Heart Rate Abnormal
on Jan 25, 2010 Female from UNITED STATES , 37 years of age, weighting 140.0 lb, was diagnosed with and was treated with Tussionex. Directly after, patient experienced the unwanted or unexpected Tussionex side effects: foetal heart rate abnormal. Tussionex dosage: 5 Ml Every 12 Hours.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • 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.

    Discuss Tussionex Side Effects

    Did You Have a Tussionex Side Effect?

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    Yes, Moderate
    Yes, Minor
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    How Effective is Tussionex for You?

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    Effective
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    Safety Alerts, Active Ingredients, Usage Information

    Alternative TUSSIONEX Names:HYDROCODO

    Active Ingredient: CHLORPHEN

    More About Tussionex

    Side Effects reported to FDA: 55

    Tussionex safety alerts: 2008

    Reported deaths: 23

    Reported hospitalizations: 19

    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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