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Tussionex Side Effects

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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.

Tussionex Side Effects Reported to FDA



Tussionex Side Effect Report#9536372
Skin Ulcer, Product Formulation Issue
This is a report of a 33-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: cough, who was treated with Tussionex (dosage: 1 Teaspoon, start time: 1998), combined with:
  • Tussionex Pennkinetic (1 Teaspoon)
  • Metformin
  • Multivitamin
  • Berberine
  • Triamcinolone
and developed a serious reaction and side effect(s): Skin Ulcer, Product Formulation Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in male patients, resulting in Skin Ulcer side effect.
Tussionex Side Effect Report#9057649
Accidental Overdose, Unresponsive To Stimuli, Somnolence, Ischaemic Hepatitis, Hepatic Steatosis
This report suggests a potential Tussionex Accidental Overdose side effect(s) that can have serious consequences. A 50-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: cough,respiratory disorder and used Tussionex (dosage: Recent Po) starting NS. After starting Tussionex the patient began experiencing various side effects, including: Accidental Overdose, Unresponsive To Stimuli, Somnolence, Ischaemic Hepatitis, Hepatic SteatosisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Accidental Overdose, may still occur.
Tussionex Side Effect Report#9035569
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a physician from US. A 4-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: croup infectious. On NS this consumer started treatment with Tussionex (dosage: 1 Half A Teaspoon Once A Day). The following drugs were being taken at the same time:
  • Benadryl
When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#9013889
Acute Pulmonary Oedema, Cardio-respiratory Arrest, Myocardial Infarction
This Acute Pulmonary Oedema side effect was reported by a physician from US. A 64-year-old female patient (weight:NA) experienced the following symptoms/conditions: bronchitis,tachyarrhythmia,blood cholesterol,hypersensitivity,asthma,venous insufficiency,lymphoedema.The patient was prescribed Tussionex (drug dosage: 5 Cc), which was initiated on
Jan 04, 2013. Concurrently used drugs:
  • Atenolol
  • Simvastatin
  • Allegra (180 Mg)
  • Singulair
  • Edecrine
  • Edecrine
  • Qvar (Inhalation Up To 2 Puffs Daily)
  • Combivent (Inhaler Q 6-8 Hours Prn Nebulizer)
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Acute Pulmonary Oedema, Cardio-respiratory Arrest, Myocardial InfarctionThese side effects may potentially be related to Tussionex.
Tussionex Side Effect Report#8468705-3
Toxicity To Various Agents
This is a report of a 4-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Tussionex (dosage: Oral,hal Teaspoon/day, start time: NS), combined with:
  • Benadryl
and developed a serious reaction and side effect(s): Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in female patients, resulting in Toxicity To Various Agents side effect.
Tussionex Side Effect Report#8457755-9
Respiratory Depression, Incorrect Dose Administered, Unresponsive To Stimuli
This report suggests a potential Tussionex Respiratory Depression side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: bronchitis and used Tussionex (dosage: 2.5 Tbl 1 Po) starting
Aug 30, 2011. After starting Tussionex the patient began experiencing various side effects, including: Respiratory Depression, Incorrect Dose Administered, Unresponsive To StimuliAdditional drugs used concurrently: NA. Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Respiratory Depression, may still occur.
Tussionex Side Effect Report#8422579-5
Toxicity To Various Agents, Resuscitation, Unresponsive To Stimuli
This Toxicity To Various Agents problem was reported by a physician from United States. A 4-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: croup infectious. On NS this consumer started treatment with Tussionex (dosage: 0.5 Tsp; Qd;). The following drugs were being taken at the same time:
  • Diphenhydramine Hcl
When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Toxicity To Various Agents, Resuscitation, Unresponsive To StimuliAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#8356940-4
Pain, Deep Vein Thrombosis, Splenic Infarction, Quality Of Life Decreased, Thrombosis, Gallbladder Disorder, Fear, Anhedonia, Injury
This Pain side effect was reported by a consumer or non-health professional from United States. A 32-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tussionex (drug dosage: NA), which was initiated on
Jan 01, 2003. Concurrently used drugs:
  • Hydrocodone Bitartrate And Acetaminophen
  • Promethazine
  • Ambien (10 Mg, Unk)
  • Yasmin
  • Humibid Dm
  • Yasmin (Unk)
  • Yasmin
  • Zithromax
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Pain, Deep Vein Thrombosis, Splenic Infarction, Quality Of Life Decreased, Thrombosis, Gallbladder Disorder, Fear, Anhedonia, InjuryThese side effects may potentially be related to Tussionex. The patient was hospitalized.
Tussionex Side Effect Report#8335983-0
Infusion Site Extravasation, Infusion Site Necrosis
This is a report of a 39-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Tussionex (dosage: NA, start time: NS), combined with:
  • Trileptal
  • Albuterol
  • Klonopin
  • Vancomycin (750mg Q12hr Ivpb Recent)
  • Atenolol
  • Topamax
  • Levothyroxine Sodium
  • Venlafaxine
and developed a serious reaction and side effect(s): Infusion Site Extravasation, Infusion Site Necrosis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in female patients, resulting in Infusion Site Extravasation side effect. The patient was hospitalized.
Tussionex Side Effect Report#8289633-2
Anxiety, Cerebrovascular Accident
This report suggests a potential Tussionex Anxiety side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Tussionex (dosage: NA) starting
Aug 20, 2009. After starting Tussionex the patient began experiencing various side effects, including: Anxiety, Cerebrovascular AccidentAdditional drugs used concurrently:
  • Nyquil
  • Yaz
  • Ascorbic Acid (Unk Unk, Prn)
  • Dayquil [dextromet Hbr,guaif,paracet,pseudoeph Hcl]
  • Pseudoephedrine Hcl
  • Yaz (Unk)
  • Lipitor
  • Pravastatin
The patient was hospitalized. Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Tussionex Side Effect Report#8210976-2
Sinus Disorder, Headache
This Sinus Disorder problem was reported by a consumer or non-health professional from United States. A 72-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Tussionex (dosage: (one Teaspoon Every 12 Hours Prn)). The following drugs were being taken at the same time: NA. When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Sinus Disorder, HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Sinus Disorder, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#8158404-X
Emotional Distress, Pulmonary Embolism, Deep Vein Thrombosis
This Emotional Distress side effect was reported by a consumer or non-health professional from United States. A 29-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Tussionex (drug dosage: NA), which was initiated on
Apr 23, 2009. Concurrently used drugs:
  • 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
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Emotional Distress, Pulmonary Embolism, Deep Vein ThrombosisThese side effects may potentially be related to Tussionex. The patient was hospitalized.
Tussionex Side Effect Report#8146593-2
Pancreatic Carcinoma
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: cough,diabetes mellitus,lipids abnormal,type 2 diabetes mellitus, who was treated with Tussionex Plain Elixir (dosage: NA, start time:
Oct 10, 2011), combined with:
  • Metformin Hcl
  • Lipitor
  • Tradjenta (5 Mg)
and developed a serious reaction and side effect(s): Pancreatic Carcinoma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex Plain Elixir treatment in male patients, resulting in Pancreatic Carcinoma side effect.
Tussionex Side Effect Report#8037584-0
Pain, Dyspnoea, Emotional Distress, Pulmonary Embolism, Fall
This report suggests a potential Tussionex Pain side effect(s) that can have serious consequences. A 32-year-old female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: cough and used Tussionex (dosage: Unk) starting
Mar 02, 2009. After starting Tussionex the patient began experiencing various side effects, including: Pain, Dyspnoea, Emotional Distress, Pulmonary Embolism, FallAdditional drugs used concurrently:
  • 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)
Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pain, may still occur.
Tussionex Side Effect Report#7954341-1
Anxiety, Depression, Abdominal Distension, Cholecystitis Chronic, Dyspepsia, Constipation, Flatulence, Cholecystectomy, Diarrhoea
This Anxiety problem was reported by a health professional from United States. A 21-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Oct 27, 2008 this consumer started treatment with Tussionex (dosage: NA). The following drugs were being taken at the same time:
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Yaz (Unk)
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Hyoscyamine
When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Anxiety, Depression, Abdominal Distension, Cholecystitis Chronic, Dyspepsia, Constipation, Flatulence, Cholecystectomy, DiarrhoeaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#7423169-3
Chronic Sinusitis, Haemorrhoids, Inflammatory Bowel Disease, Crohn's Disease, Irritable Bowel Syndrome
This Chronic Sinusitis side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: cough,acne.The patient was prescribed Tussionex (drug dosage: NA), which was initiated on
Aug 13, 2002. Concurrently used drugs:
  • Accutane
  • Amoxicillin
  • Methylprednisolone Acetate
  • Guaifen
  • Promethazine Hcl And Codeine
  • Benzonatate
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Chronic Sinusitis, Haemorrhoids, Inflammatory Bowel Disease, Crohn's Disease, Irritable Bowel SyndromeThese side effects may potentially be related to Tussionex. The patient was hospitalized.
Tussionex Side Effect Report#7382107-2
Left Ventricular Dysfunction, Discomfort, Scar, Metastases To Central Nervous System, Gait Disturbance, Dehydration, Bone Density Decreased, Osteoporosis, Neoplasm Recurrence
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: NA, who was treated with Tussionex (dosage: NA, start time:
May 15, 2007), combined with:
  • Zofran (4 Mg / Q4h Prn)
  • Minocin
  • Activella
  • Cyclobenzaprine (10 Mg, Every 8 Hours As Needed)
  • Zometa (3.5 Mg, Qmo)
  • Paxil
  • Clindamycin
  • Megace
and developed a serious reaction and side effect(s): Left Ventricular Dysfunction, Discomfort, Scar, Metastases To Central Nervous System, Gait Disturbance, Dehydration, Bone Density Decreased, Osteoporosis, Neoplasm Recurrence after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in female patients, resulting in Left Ventricular Dysfunction side effect. The patient was hospitalized.
Tussionex Side Effect Report#7372883-7
Cholelithiasis, Cholecystectomy, Cholecystitis Chronic
This report suggests a potential Tussionex Cholelithiasis side effect(s) that can have serious consequences. A female patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Tussionex (dosage: NA) starting
Jan 01, 2008. After starting Tussionex the patient began experiencing various side effects, including: Cholelithiasis, Cholecystectomy, Cholecystitis ChronicAdditional drugs used concurrently:
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Hyoscyamine
Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cholelithiasis, may still occur.
Tussionex Side Effect Report#7249401-7
Dysphagia, Aphasia, Fatigue, Headache, Vitreous Floaters, Viith Nerve Paralysis, Hemiparesis, Facial Paresis, Insomnia
This Dysphagia problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: upper respiratory tract infection. On
Feb 01, 2007 this consumer started treatment with Tussionex (dosage: Unk). The following drugs were being taken at the same time:
  • 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)
When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Dysphagia, Aphasia, Fatigue, Headache, Vitreous Floaters, Viith Nerve Paralysis, Hemiparesis, Facial Paresis, InsomniaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Dysphagia, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#7224114-6
Angioedema, Dysphagia
This Angioedema side effect was reported by a pharmacist from United States. A 54-year-old male patient (weight:NA) experienced the following symptoms/conditions: bronchitis.The patient was prescribed Tussionex (drug dosage: 5ml Q12h Prn Po Recent), which was initiated on NS. Concurrently used drugs:
  • Prednisone
  • Albuterol
  • Nystatin
  • Levaquin
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Angioedema, DysphagiaThese side effects may potentially be related to Tussionex. The patient was hospitalized.
Tussionex Side Effect Report#6994678-6
Gastrooesophageal Reflux Disease, Pneumonia, Pneumonia Aspiration
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: bronchitis,pneumonia, who was treated with Tussionex (dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours Oral, start time:
Jan 01, 2006), combined with: NA. and developed a serious reaction and side effect(s): Gastrooesophageal Reflux Disease, Pneumonia, Pneumonia Aspiration after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in female patients, resulting in Gastrooesophageal Reflux Disease side effect. The patient was hospitalized.
Tussionex Side Effect Report#6981292-1
Contraindication To Medical Treatment
This report suggests a potential Tussionex Contraindication To Medical Treatment side effect(s) that can have serious consequences. A 3-year-old patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: croup infectious and used Tussionex (dosage: (1/2 Tsp At Bedtime Oral)) starting
Jan 01, 2009. After starting Tussionex the patient began experiencing various side effects, including: Contraindication To Medical TreatmentAdditional drugs used concurrently: NA. Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Contraindication To Medical Treatment, may still occur.
Tussionex Side Effect Report#6965271-6
Aspiration, Gastrooesophageal Reflux Disease, Liquid Product Physical Issue, Pneumonia, Product Colour Issue, Product Taste Abnormal, Therapeutic Response Decreased
This Aspiration problem was reported by a consumer or non-health professional from United States. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: bronchitis. On
Jan 01, 2006 this consumer started treatment with Tussionex (dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours, Oral). The following drugs were being taken at the same time:
  • Plavix
  • Coumadin
When using Tussionex, the patient experienced the following unwanted symptoms/side effects: Aspiration, Gastrooesophageal Reflux Disease, Liquid Product Physical Issue, Pneumonia, Product Colour Issue, Product Taste Abnormal, Therapeutic Response DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aspiration, may become evident only after a product is in use by the general population.
Tussionex Side Effect Report#6932628-9
Liquid Product Physical Issue, Pneumonia, Product Taste Abnormal, Therapeutic Response Decreased
This Liquid Product Physical Issue side effect was reported by a consumer or non-health professional from United States. A female patient (weight:NA) experienced the following symptoms/conditions: bronchitis.The patient was prescribed Tussionex (drug dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours, Oral)), which was initiated on
Jan 01, 2006. Concurrently used drugs:
  • Plavix
  • Coumadin
.After starting to take Tussionex the consumer reported adverse symptoms, such as: Liquid Product Physical Issue, Pneumonia, Product Taste Abnormal, Therapeutic Response DecreasedThese side effects may potentially be related to Tussionex. The patient was hospitalized.
Tussionex Side Effect Report#6554278-9
Foetal Heart Rate Abnormal
This is a report of a 37-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: cough, who was treated with Tussionex (dosage: 5 Ml Every 12 Hours, start time:
Dec 10, 2009), combined with: NA. and developed a serious reaction and side effect(s): Foetal Heart Rate Abnormal after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Tussionex treatment in female patients, resulting in Foetal Heart Rate Abnormal side effect.


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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.

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Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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 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.

    Discuss Tussionex Side Effects

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    How Effective is Tussionex for You?

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    Tussionex Safety Alerts, Active Ingredients, Usage Information

    NDC53014-548
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameTussionex Pennkinetic
    Namehydrocodone polistirex and chlorpheniramine polistirex
    Dosage FormSUSPENSION, EXTENDED RELEASE
    RouteORAL
    On market since19871231
    LabelerUnither Manufacturing, LLC
    Active Ingredient(s)CHLORPHENIRAMINE; HYDROCODONE
    Strength(s)8; 10
    Unit(s)mg/5mL; mg/5mL
    Pharma ClassOpioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Recep

    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]

    Latest Tussionex clinical trials

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