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Enfuvirtide Side Effects

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Common Enfuvirtide Side Effects


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

Pyrexia (12)
Death (11)
Immune Reconstitution Syndrome (8)
Injection Site Reaction (6)
Rhabdomyolysis (6)
Cytolytic Hepatitis (5)
Diarrhoea (5)
Renal Failure Acute (5)
Impaired Gastric Emptying (4)
Virologic Failure (3)
Neurological Symptom (3)
Hypoxia (3)
Tuberculosis (3)
Lymphadenitis (3)
Oesophageal Candidiasis (3)
Organising Pneumonia (3)
Osteomyelitis (3)
Sepsis (3)
Staphylococcal Abscess (3)
Staphylococcal Bacteraemia (3)

➢ 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.

Enfuvirtide Side Effects Reported to FDA



Enfuvirtide Side Effect Report#9668668
Maternal Exposure During Pregnancy
This is a report of a 21-year-old female patient (weight: NA) from RO, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: NA, start time: 2004), combined with:
  • Lopinavir/ritonavir
  • Lopinavir/ritonavir
  • Lopinavir/ritonavir
  • Lamivudine/zidovudine
  • Lamivudine/zidovudine
  • Lamivudine/zidovudine
  • Lamivudine/zidovudine
  • Nevirapine
and developed a serious reaction and side effect(s): Maternal Exposure During Pregnancy after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in female patients, resulting in Maternal Exposure During Pregnancy side effect.
Enfuvirtide Side Effect Report#9626524
Adenocarcinoma Of Colon, Arthralgia, Bronchospasm, Colectomy, Cough, Diarrhoea, Dizziness, Dry Skin, Dysuria
This report suggests a potential Enfuvirtide Adenocarcinoma Of Colon side effect(s) that can have serious consequences. A 51-year-old male patient (weight: NA) from CA was diagnosed with the following symptoms/conditions: NA and used Enfuvirtide (dosage: NA) starting NS. After starting Enfuvirtide the patient began experiencing various side effects, including: Adenocarcinoma Of Colon, Arthralgia, Bronchospasm, Colectomy, Cough, Diarrhoea, Dizziness, Dry Skin, DysuriaAdditional drugs used concurrently:
  • Isentress
  • Prezista
  • Videx Ec
  • Viread
  • Ritonavir
  • Bactrim
  • Fusidic Acid
  • Gabapentin
The patient was hospitalized. Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Adenocarcinoma Of Colon, may still occur.
Enfuvirtide Side Effect Report#9124621
Basedow^s Disease, Abdominal Pain, Pyrexia
This Basedow^s Disease problem was reported by a health professional from Country Not Specified. A 40-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: hiv infection. On NS this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Tenofovir
  • Lamivudine
  • Atazanavir
  • Ritonavir
  • Fosamprenavir
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: Basedow^s Disease, Abdominal Pain, PyrexiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Basedow^s Disease, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#8407256-9
Cutaneous Amyloidosis
This Cutaneous Amyloidosis side effect was reported by a consumer or non-health professional from United States. A 55-year-old female patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: Cutaneous AmyloidosisThese side effects may potentially be related to Enfuvirtide.
Enfuvirtide Side Effect Report#7910263-3
Dementia
This is a report of a 51-year-old male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: NA, start time:
Jan 01, 2006), combined with:
  • Emtricitabine
  • Lopinavir/ritonavir
  • Tenofovir Disoproxil Fumarate
and developed a serious reaction and side effect(s): Dementia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in male patients, resulting in Dementia side effect. The patient was hospitalized.
Enfuvirtide Side Effect Report#7283054-7
Neutropenia, Pyrexia, Cytomegalovirus Infection, Diarrhoea
This report suggests a potential Enfuvirtide Neutropenia side effect(s) that can have serious consequences. A male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: hiv infection and used Enfuvirtide (dosage: NA) starting
Apr 14, 2008. After starting Enfuvirtide the patient began experiencing various side effects, including: Neutropenia, Pyrexia, Cytomegalovirus Infection, DiarrhoeaAdditional drugs used concurrently:
  • Truvada
  • Kaletra
  • Sulfamethoxazole And Trimethoprim
  • Bromazepam
  • Primperan Tab
  • Valganciclovir Hcl
  • Verapamil
  • Azadose (Tdd: 1200 Mg Per Week)
The patient was hospitalized. Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Neutropenia, may still occur.
Enfuvirtide Side Effect Report#7081045-2
Impaired Gastric Emptying, Pyrexia
This Impaired Gastric Emptying problem was reported by a physician from France. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: hiv infection. On
Mar 28, 2009 this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Sustiva
  • Truvada
  • Rifater
  • Myambutol
  • Bactrim
  • Speciafoldine
  • Solu-medrol
  • Solupred
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: Impaired Gastric Emptying, PyrexiaThe patient was hospitalized and became disabled.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Impaired Gastric Emptying, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#7042891
Depression, Prostate Cancer, Diarrhoea, Injection Site Reaction, Neuropathy Peripheral
This Depression side effect was reported by a health professional from CA. A 56-year-old male patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Raltegravir
.After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: Depression, Prostate Cancer, Diarrhoea, Injection Site Reaction, Neuropathy PeripheralThese side effects may potentially be related to Enfuvirtide.
Enfuvirtide Side Effect Report#7020478-7
Anaemia, Bronchitis
This is a report of a female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: Last Dose Prior To Sae: 11 Sep 2010., start time:
Sep 08, 2010), combined with:
  • Etravirine (Date Of Last Dose: 11 Sep 2010.)
  • Maraviroc (Last Dose: 11 Sep 2010.)
  • Darunavir Ethanolate (Last Dose: 11 Sep 2010.)
and developed a serious reaction and side effect(s): Anaemia, Bronchitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in female patients, resulting in Anaemia side effect. The patient was hospitalized.
Enfuvirtide Side Effect Report#6923143-7
Amyloidosis
This report suggests a potential Enfuvirtide Amyloidosis side effect(s) that can have serious consequences. A 47-year-old male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: NA and used Enfuvirtide (dosage: NA) starting NS. After starting Enfuvirtide the patient began experiencing various side effects, including: AmyloidosisAdditional drugs used concurrently: NA. Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Amyloidosis, may still occur.
Enfuvirtide Side Effect Report#6758646-1
Virologic Failure
This Virologic Failure problem was reported by a health professional from Spain. A 14-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: hiv infection. On NS this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Ritonavir
  • Tenofovir
  • Tipranavir
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: Virologic FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Virologic Failure, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#6758645-X
Virologic Failure
This Virologic Failure side effect was reported by a health professional from Spain. A 16-year-old male patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Didanosine
  • Abacavir
  • Lamivudine
  • Ritonavir
  • Tipranavir
.After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: Virologic FailureThese side effects may potentially be related to Enfuvirtide.
Enfuvirtide Side Effect Report#6758607-2
Treatment Failure
This is a report of a 11-year-old male patient (weight: NA) from Spain, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: NA, start time: NS), combined with:
  • Saquinavir
  • Didanosine
  • Lopinavir
  • Ritonavir
and developed a serious reaction and side effect(s): Treatment Failure after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in male patients, resulting in Treatment Failure side effect.
Enfuvirtide Side Effect Report#6736159-0
Acute Respiratory Distress Syndrome, Hyperglycaemia, Necrotising Colitis, Premature Baby, Small Intestinal Perforation
This report suggests a potential Enfuvirtide Acute Respiratory Distress Syndrome side effect(s) that can have serious consequences. A male patient (weight: NA) from Italy was diagnosed with the following symptoms/conditions: hepatitis c and used Enfuvirtide (dosage: Another Indication: Hiv Infection) starting NS. After starting Enfuvirtide the patient began experiencing various side effects, including: Acute Respiratory Distress Syndrome, Hyperglycaemia, Necrotising Colitis, Premature Baby, Small Intestinal PerforationAdditional drugs used concurrently:
  • Stavudine (Another Indication: Hiv Infection)
  • Tenofovir (Another Indication: Hiv Infection)
  • Ritonavir (Another Indication: Hiv Infection)
  • Tipranavir (Another Indication: Hiv Infection)
  • Zidovudine (Another Indication: Hiv Infection)
  • Lamivudine (Another Indication: Hiv Infection)
Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Acute Respiratory Distress Syndrome, may still occur.
Enfuvirtide Side Effect Report#6724994
Osteomyelitis, Extradural Abscess
This Osteomyelitis problem was reported by a health professional from ES. A 38-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Saquinavir
  • Lopinavir/ritonavir
  • Tenofovir
  • Sulfamethoxazole/trimethoprim
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: Osteomyelitis, Extradural AbscessAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Osteomyelitis, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#6723753-6
Immune Reconstitution Syndrome, Impaired Gastric Emptying, Tuberculosis
This Immune Reconstitution Syndrome side effect was reported by a physician from United Kingdom. A 34-year-old female patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: NA), which was initiated on
Nov 06, 2008. Concurrently used drugs:
  • Emtricitabine/tenofovir Disoproxil Fumarate
  • Efavirenz
  • Efavirenz (Residual At 963 Ng/ml)
  • Efavirenz
  • Rifater
  • Myambutol
  • Pirilene
  • Rifampicin
.After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: Immune Reconstitution Syndrome, Impaired Gastric Emptying, TuberculosisThese side effects may potentially be related to Enfuvirtide. The patient was hospitalized and became disabled.
Enfuvirtide Side Effect Report#6719511-9
Acute Respiratory Distress Syndrome, Bone Disorder, Hyperglycaemia, Necrotising Colitis, Premature Baby
This is a report of a male patient (weight: NA) from Italy, suffering from the following health symptoms/conditions: hepatitis c, who was treated with Enfuvirtide (dosage: Another Indication: Hiv Infection, start time: NS), combined with:
  • Stavudine (Another Indication: Hiv Infection)
  • Tenofovir Disoproxil Fumarate (Another Indication: Hiv Infection)
  • Ritonavir (Another Indication: Hiv Infection)
  • Tipranavir (Another Indication: Hiv Infection)
  • Zidovudine (Another Indication: Hiv Infection)
  • Lamivudine (Another Indication: Hiv Infection)
and developed a serious reaction and side effect(s): Acute Respiratory Distress Syndrome, Bone Disorder, Hyperglycaemia, Necrotising Colitis, Premature Baby after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in male patients, resulting in Acute Respiratory Distress Syndrome side effect.
Enfuvirtide Side Effect Report#6640085-5
Furuncle, Injection Site Reaction, Rash Pustular, Staphylococcal Abscess, Staphylococcal Bacteraemia, Status Epilepticus, Virologic Failure
This report suggests a potential Enfuvirtide Furuncle side effect(s) that can have serious consequences. A 55-year-old male patient (weight: NA) from France was diagnosed with the following symptoms/conditions: hiv infection,infection prophylaxis and used Enfuvirtide (dosage: NA) starting
Aug 01, 2005. After starting Enfuvirtide the patient began experiencing various side effects, including: Furuncle, Injection Site Reaction, Rash Pustular, Staphylococcal Abscess, Staphylococcal Bacteraemia, Status Epilepticus, Virologic FailureAdditional drugs used concurrently:
  • Co-trimoxazole
  • Tmc114
  • Pyrimethamine Tab
  • Sulfadiazine
  • Folinic Acid
Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Furuncle, may still occur.
Enfuvirtide Side Effect Report#6624761-6
Nervous System Disorder, Treatment Failure
This Nervous System Disorder problem was reported by a health professional from Netherlands. A 50-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Maraviroc
  • Tenofovir
  • Zidovudine
  • Lamivudine
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: Nervous System Disorder, Treatment FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Nervous System Disorder, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#6610350-6
Hospitalisation
This Hospitalisation side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: Last Dose: 02 Feb 2010), which was initiated on
Mar 19, 2009. Concurrently used drugs:
  • Darunavir (Last Dose On: 01 Feb 2010)
  • Raltegravir (Last Dose: 01 Feb 2010.)
  • Ritonavir (Last Dose On: 02 Feb 2010.)
  • Tricor (Frequency : Every Day, Approximate Duration Of Use: 23 Month)
  • Centrum (Frequency : Every Day, Approximate Duration Of Use: 7 Years)
  • Prepacol
.After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: HospitalisationThese side effects may potentially be related to Enfuvirtide. The patient was hospitalized.
Enfuvirtide Side Effect Report#6583612-9
Dizziness, Headache, Hospitalisation, Vision Blurred
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: Last Dose: 02 Feb 2010, start time:
Mar 19, 2009), combined with:
  • Darunavir (Last Dose On: 01 Feb 2010)
  • Raltegravir (Last Dose: 01 Feb 2010.)
  • Ritonavir (Last Dose On: 02 Feb 2010.)
  • Tricor (Frequency : Every Day, Approximate Duration Of Use: 23 Month)
  • Centrum (Frequency : Every Day, Approximate Duration Of Use: 7 Years)
  • Prepacol
and developed a serious reaction and side effect(s): Dizziness, Headache, Hospitalisation, Vision Blurred after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in male patients, resulting in Dizziness side effect. The patient was hospitalized.
Enfuvirtide Side Effect Report#6565673-6
Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia
This report suggests a potential Enfuvirtide Blood Creatine Phosphokinase Increased side effect(s) that can have serious consequences. A male patient (weight: NA) from United States was diagnosed with the following symptoms/conditions: hiv infection and used Enfuvirtide (dosage: Form: Oral Solution) starting
Nov 14, 2008. After starting Enfuvirtide the patient began experiencing various side effects, including: Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, PyrexiaAdditional drugs used concurrently:
  • Maraviroc
  • Bactrim Ds
  • Zelitrex
  • Azadose
  • Epivir
  • Isentress
  • Etravirine
  • Josamycin
The patient was hospitalized. Although Enfuvirtide demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Blood Creatine Phosphokinase Increased, may still occur.
Enfuvirtide Side Effect Report#6521434-5
Appendicitis
This Appendicitis problem was reported by a health professional from Czech Republic. A 33-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Enfuvirtide (dosage: NA). The following drugs were being taken at the same time:
  • Tenofovir
  • Tipranavir
  • Ritonavir
When using Enfuvirtide, the patient experienced the following unwanted symptoms/side effects: AppendicitisThe 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 Appendicitis, may become evident only after a product is in use by the general population.
Enfuvirtide Side Effect Report#6515303-4
Neurological Symptom
This Neurological Symptom side effect was reported by a physician from United States. A male patient (weight:NA) experienced the following symptoms/conditions: hiv infection.The patient was prescribed Enfuvirtide (drug dosage: Temporarily Held), which was initiated on
Jul 29, 2008. Concurrently used drugs:
  • Raltegravir (Temporarily Held)
  • Darunavir (Temporarily Held)
  • Ritonavir (Temporarily Held)
  • Etravirine (Temporarily Held)
  • Hydrochlorothiazide
  • Dapsone
  • Lopid
  • Neurontin
.After starting to take Enfuvirtide the consumer reported adverse symptoms, such as: Neurological SymptomThese side effects may potentially be related to Enfuvirtide. The patient was hospitalized.
Enfuvirtide Side Effect Report#6515301-0
Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia
This is a report of a male patient (weight: NA) from United States, suffering from the following health symptoms/conditions: hiv infection, who was treated with Enfuvirtide (dosage: Form: Oral Solution, start time:
Nov 14, 2008), combined with:
  • Maraviroc
  • Bactrim Ds
  • Zelitrex
  • Azadose
  • Epivir
  • Isentress
  • Etravirine
  • Josamycin
and developed a serious reaction and side effect(s): Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Enfuvirtide treatment in male patients, resulting in Blood Creatine Phosphokinase Increased side effect. The patient was hospitalized.


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The appearance of Enfuvirtide 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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    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.

    Enfuvirtide 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.

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    Side Effects reported to FDA: 105

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    Reported deaths: 76

    Reported hospitalizations: 212

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