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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
This is a report of a 33-year-old male patient (weight: NA) from US, suffering from the following 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). The consumer presented with:
  • Skin Ulcer
  • Product Formulation Issue
which developed 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.

Accidental Overdose, Unresponsive To Stimuli, Somnolence, Ischaemic Hepatitis, Hepatic Steatosis
This report suggests a potential Tussionex Accidental Overdose, Unresponsive To Stimuli, Somnolence, Ischaemic Hepatitis, Hepatic Steatosis 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. Soon after starting Tussionex the patient began experiencing various side effects, including:
  • Accidental Overdose
  • Unresponsive To Stimuli
  • Somnolence
  • Ischaemic Hepatitis
  • Hepatic Steatosis
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.

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 commencing Tussionex, the patient experienced the following unwanted symptoms/side effects:
  • Toxicity To Various Agents
Although 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.

Acute Pulmonary Oedema, Cardio-respiratory Arrest, Myocardial Infarction
This is a report of a 64-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: bronchitis,tachyarrhythmia,blood cholesterol,hypersensitivity,asthma,venous insufficiency,lymphoedema and was treated with Tussionex (dosage: 5 Cc) starting 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)
Soon after that, the consumer experienced the following side effects:
  • Acute Pulmonary Oedema
  • Cardio-respiratory Arrest
  • Myocardial Infarction
This opens a possibility that Tussionex treatment could cause the above reactions, including acute pulmonary oedema, and some female subjects may be more susceptible.


Toxicity To Various Agents
A 4-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: NA started Tussionex treatment (dosage: Oral,hal Teaspoon/day) on NS. Soon after starting Tussionex treatment, the subject experienced various side effects, including:
  • Toxicity To Various Agents
Concurrently used drugs:
  • Benadryl
This finding indicates that some female patients could be more vulnerable to Tussionex.

Respiratory Depression, Incorrect Dose Administered, Unresponsive To Stimuli
A male patient from UNITED STATES (weight: NA) experienced symptoms, such as: bronchitis and was treated with Tussionex(dosage: 2.5 Tbl 1 Po). The treatment was initiated on Aug 30, 2011. After that a consumer reported the following side effect(s):
  • Respiratory Depression
  • Incorrect Dose Administered
  • Unresponsive To Stimuli
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Tussionex efficacy: NA.

Toxicity To Various Agents, Resuscitation, Unresponsive To Stimuli
In this report, Tussionex was administered for the following condition: croup infectious.A 4-year-old female consumer from UNITED STATES (weight: NA) started Tussionex treatment (dosage: 0.5 Tsp; Qd;) on NS.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Toxicity To Various Agents
  • Resuscitation
  • Unresponsive To Stimuli
A possible interaction with other drugs could have contributed to this reaction:
  • Diphenhydramine Hcl
Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Tussionex treatment could be related to the listed above side effect(s).

Pain, Deep Vein Thrombosis, Splenic Infarction, Quality Of Life Decreased, Gallbladder Disorder, Fear, Anhedonia, Injury
This is a report of the following Tussionex side effect(s):
  • Pain
  • Deep Vein Thrombosis
  • Splenic Infarction
  • Quality Of Life Decreased
  • Gallbladder Disorder
  • Fear
  • Anhedonia
  • Injury
A 32-year-old female patient from UNITED STATES (weight: NA) presented with the following condition: NA and received a treatment with Tussionex (dosage: NA) starting: Jan 01, 2003.The following concurrently used drugs could have generated interactions:
  • Hydrocodone Bitartrate And Acetaminophen
  • Promethazine
  • Ambien (10 Mg, Unk)
  • Yasmin
  • Humibid Dm
  • Yasmin (Unk)
  • Yasmin
  • Zithromax
The patient was hospitalized.This report suggests that a Tussionex treatment could be associated with the listed above side effect(s).

Infusion Site Extravasation, Infusion Site Necrosis
This Tussionex report was submitted by a 39-year-old female consumer from UNITED STATES (weight: NA). The patient was diagnosed with: NA and Tussionex was administered (dosage: NA) starting: NS. The consumer developed a set of symptoms:
  • Infusion Site Extravasation
  • Infusion Site Necrosis
Other drugs used simultaneously:
  • Trileptal
  • Albuterol
  • Klonopin
  • Vancomycin (750mg Q12hr Ivpb Recent)
  • Atenolol
  • Topamax
  • Levothyroxine Sodium
  • Venlafaxine
The patient was hospitalized.Those unexpected symptoms could be linked to a Tussionex treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Anxiety, Cerebrovascular Accident
This is a report of a possible correlation between Tussionex use and the following symptoms/side effect(s):
  • Anxiety
  • Cerebrovascular Accident
which could contribute to an assessment of Tussionex risk profile.A 29-year-old female consumer from UNITED STATES (weight: NA) was suffering from NA and was treated with Tussionex (dosage: NA) starting Aug 20, 2009.Other concurrent medications:
  • Nyquil
  • Yaz
  • Ascorbic Acid (Unk Unk, Prn)
  • Dayquil [dextromet Hbr,guaif,paracet,pseudoeph Hcl]
  • Pseudoephedrine Hcl
  • Yaz (Unk)
  • Lipitor
  • Pravastatin
The patient was hospitalized.

Sinus Disorder, Headache
A 72-year-old female patient from UNITED STATES (weight: NA) presented with the following symptoms: NA and after a treatment with Tussionex (dosage: (one Teaspoon Every 12 Hours Prn)) experienced the following side effect(s):
  • Sinus Disorder
  • Headache
The treatment was started on NS. Tussionex was used in combination with the following drugs: NA.This report could alert potential Tussionex consumers.

Emotional Distress, Pulmonary Embolism, Deep Vein Thrombosis
In this report, a 29-year-old female patient from UNITED STATES (weight: NA) was affected by a possible Tussionex side effect.The patient was diagnosed with NA. After a treatment with Tussionex (dosage: NA, start date: Apr 23, 2009), the patient experienced the following side effect(s):
  • Emotional Distress
  • Pulmonary Embolism
  • Deep Vein Thrombosis
The following simultaneously used drugs could have led to this reaction:
  • 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
The patient was hospitalized.The findings here stress that side effects should be taken into consideration when evaluating a Tussionex treatment.

Pancreatic Carcinoma
This is a report of a male patient from UNITED STATES (weight: NA), who used Tussionex Plain Elixir (dosage: NA) for a treatment of cough,diabetes mellitus,lipids abnormal,type 2 diabetes mellitus. After starting a treatment on Oct 10, 2011, the patient experienced the following side effect(s):
  • Pancreatic Carcinoma
The following drugs could possibly have interacted with the Tussionex Plain Elixir treatment
  • Metformin Hcl
  • Lipitor
  • Tradjenta (5 Mg)
Taken together, these observations suggest that a Tussionex Plain Elixir treatment could be related to side effect(s), such as Pancreatic Carcinoma.

Pain, Dyspnoea, Emotional Distress, Pulmonary Embolism, Fall
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: cough. The patient was prescribed Tussionex (dosage: Unk), which was started on Mar 02, 2009. Concurrently used drugs:
  • 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)
When starting to take Tussionex the consumer reported the following symptoms:
  • Pain
  • Dyspnoea
  • Emotional Distress
  • Pulmonary Embolism
  • Fall
These side effects may potentially be related to Tussionex.

Anxiety, Depression, Abdominal Distension, Cholecystitis Chronic, Dyspepsia, Constipation, Flatulence, Cholecystectomy, Diarrhoea
This is a Tussionex side effect report of a 21-year-old female patient (weight:NA) from UNITED STATES, suffering from the following symptoms/conditions: NA, who was treated with Tussionex (dosage:NA, start time: Oct 27, 2008), combined with:
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Yaz (Unk)
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Hyoscyamine
, and developed a serious reaction and a anxiety side effect. The patient presented with:
  • Anxiety
  • Depression
  • Abdominal Distension
  • Cholecystitis Chronic
  • Dyspepsia
  • Constipation
  • Flatulence
  • Cholecystectomy
  • Diarrhoea
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Tussionex treatment in female patients suffering from NA, resulting in anxiety.

Chronic Sinusitis, Haemorrhoids, Inflammatory Bowel Disease, Crohn's Disease, Irritable Bowel Syndrome
This report suggests a potential Tussionex chronic sinusitis side effect(s) that can have serious consequences. A female patient from UNITED STATES (weight:NA) was diagnosed with the following health condition(s): cough,acne and used Tussionex (dosage: NA) starting Aug 13, 2002. Soon after starting Tussionex the patient began experiencing various side effects, including:
  • Chronic Sinusitis
  • Haemorrhoids
  • Inflammatory Bowel Disease
  • Crohn's Disease
  • Irritable Bowel Syndrome
Drugs used concurrently:
  • Accutane
  • Amoxicillin
  • Methylprednisolone Acetate
  • Guaifen
  • Promethazine Hcl And Codeine
  • Benzonatate
The patient was hospitalized. Although Tussionex demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as chronic sinusitis, may still occur.

Left Ventricular Dysfunction, Discomfort, Scar, Metastases To Central Nervous System, Gait Disturbance, Dehydration, Bone Density Decreased, Osteoporosis, Neoplasm Recurrence
This left ventricular dysfunction problem was reported by a consumer or non-health professional from UNITED STATES. A female patient (weight: NA) was diagnosed with the following medical condition(s): NA.On May 15, 2007 a consumer started treatment with Tussionex (dosage: NA). The following drugs/medications were being taken at the same time:
  • Zofran (4 Mg / Q4h Prn)
  • Minocin
  • Activella
  • Cyclobenzaprine (10 Mg, Every 8 Hours As Needed)
  • Zometa (3.5 Mg, Qmo)
  • Paxil
  • Clindamycin
  • Megace
When commencing Tussionex, the patient experienced the following unwanted symptoms /side effects:
  • Left Ventricular Dysfunction
  • Discomfort
  • Scar
  • Metastases To Central Nervous System
  • Gait Disturbance
  • Dehydration
  • Bone Density Decreased
  • Osteoporosis
  • Neoplasm Recurrence
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as left ventricular dysfunction, may become evident only after a product is in use by the general population.

Cholelithiasis, Cholecystectomy, Cholecystitis Chronic
This is a Tussionex side effect report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: NA and was treated with Tussionex (dosage: NA) starting Jan 01, 2008. Concurrently used drugs:
  • Fluticasone Propionate (Unk)
  • Yaz (Unk)
  • Oxycodone Hcl And Acetaminophen (325 Mg, Unk)
  • Hyoscyamine
Soon after that, the consumer experienced the following of symptoms:
  • Cholelithiasis
  • Cholecystectomy
  • Cholecystitis Chronic
This opens a possibility that Tussionex could cause cholelithiasis and that some female patients may be more susceptible.

Dysphagia, Aphasia, Fatigue, Headache, Vitreous Floaters, Viith Nerve Paralysis, Hemiparesis, Facial Paresis, Insomnia
A female patient (weight: NA) from UNITED STATES with the following symptoms: upper respiratory tract infection started Tussionex treatment (dosage: Unk) on Feb 01, 2007. Soon after starting Tussionex treatment, the consumer experienced several side effects, including:
  • Dysphagia
  • Aphasia
  • Fatigue
  • Headache
  • Vitreous Floaters
  • Viith Nerve Paralysis
  • Hemiparesis
  • Facial Paresis
  • Insomnia
. Concurrently used drugs:
  • 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)
The patient was hospitalized. This finding indicates that some patients can be more vulnerable to developing Tussionex side effects, such as dysphagia.

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 (dosage: 5ml Q12h Prn Po Recent), which was started on NS. Concurrently used drugs:
  • Prednisone
  • Albuterol
  • Nystatin
  • Levaquin
.When starting to take Tussionex the consumer reported symptoms, such as:
  • Angioedema
  • Dysphagia
These side effects may potentially be related to Tussionex. The patient was hospitalized.

Gastrooesophageal Reflux Disease, Pneumonia, Pneumonia Aspiration
This is a report of a female patient (weight: NA) from UNITED STATES, suffering from the following 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). The consumer presented with:
  • Gastrooesophageal Reflux Disease
  • Pneumonia
  • Pneumonia Aspiration
which developed 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.

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. Soon after starting Tussionex the patient began experiencing various side effects, including:
  • Contraindication To Medical Treatment
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.

Aspiration, Gastrooesophageal Reflux Disease, Liquid Product Physical Issue, Pneumonia, Product Colour Issue, Product Taste Abnormal, Therapeutic Response Decreased
This Aspiration, Gastrooesophageal Reflux Disease, Liquid Product Physical Issue, Pneumonia, Product Colour Issue, Product Taste Abnormal, Therapeutic Response Decreased 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 commencing 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 Decreased
The 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.

Liquid Product Physical Issue, Pneumonia, Product Taste Abnormal, Therapeutic Response Decreased
This is a report of a female patient (weight: NA) from UNITED STATES. The patient developed the following symptoms/conditions: bronchitis and was treated with Tussionex (dosage: 5 Ml 1x/12 Hours, One Teaspoon Every 12 Hours, Oral)) starting Jan 01, 2006. Concurrently used drugs:
  • Plavix
  • Coumadin
Soon after that, the consumer experienced the following side effects:
  • Liquid Product Physical Issue
  • Pneumonia
  • Product Taste Abnormal
  • Therapeutic Response Decreased
The patient was hospitalized. This opens a possibility that Tussionex treatment could cause the above reactions, including liquid product physical issue, and some female subjects may be more susceptible.

Foetal Heart Rate Abnormal
A 37-year-old female patient (weight: NA) from UNITED STATES with the following symptoms/conditions: cough started Tussionex treatment (dosage: 5 Ml Every 12 Hours) on Dec 10, 2009. Soon after starting Tussionex treatment, the subject experienced various side effects, including:
  • Foetal Heart Rate Abnormal
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Tussionex.

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Keep Track of Side Effects

Note Your Observations

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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

    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

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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]

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