ENFUVIRTIDE Side Effects

7020478-7 | Anaemia, Bronchitis
on Sep 17, 2010 Female patient from UNITED STATES , weighting 130.1 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: anaemia, bronchitis (What is bronchitis?). Enfuvirtide dosage: Last Dose Prior To Sae: 11 Sep 2010.. During the same period patient was treated with ETRAVIRINE (Date Of Last Dose: 11 Sep 2010.) (View Etravirine Review and Etravirine Label ), MARAVIROC (Last Dose: 11 Sep 2010.) (View Maraviroc Review and Maraviroc Label ), DARUNAVIR ETHANOLATE (Last Dose: 11 Sep 2010.) (View Darunavir Ethanolate Review and Darunavir Ethanolate Label ). Patient was hospitalized.

6923143-7 | Amyloidosis
Patient was taking Enfuvirtide (View Usage). Patient had the following side effects: amyloidosis on Aug 02, 2010 from UNITED STATES Additional patient health information: Male patient , 47 years of age, . Enfuvirtide dosage: .

6758646-1 | Virologic Failure
Adverse event was reported on May 24, 2010 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) was diagnosed with hiv infection (What is hiv infection?) and. Location: SPAIN , 14 years of age, After Enfuvirtide was administered, patient had the following side effects: virologic failure. During the same period patient was treated with RITONAVIR (View Ritonavir Review and Ritonavir Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ), TIPRANAVIR (View Tipranavir Review and Tipranavir Label ).

6758645-X | Virologic Failure
on May 24, 2010 Male patient from SPAIN , 16 years of age, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: virologic failure. Enfuvirtide dosage: . During the same period patient was treated with DIDANOSINE (View Didanosine Review and Didanosine Label ), ABACAVIR (View Abacavir Review and Abacavir Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ), TIPRANAVIR (View Tipranavir Review and Tipranavir Label ).


6758607-2 | Treatment Failure
on May 24, 2010 Male patient from SPAIN , child 11 years of age, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: treatment failure. Enfuvirtide dosage: . During the same period patient was treated with SAQUINAVIR (View Saquinavir Review and Saquinavir Label ), DIDANOSINE (View Didanosine Review and Didanosine Label ), LOPINAVIR (View Lopinavir Review and Lopinavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ).

6736159-0 | Acute Respiratory Distress Syndrome, Hyperglycaemia, Necrotising Colitis, Premature Baby, Small Intestinal Perforation
Patient was taking Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: acute respiratory distress syndrome, hyperglycaemia, necrotising colitis, premature baby, small intestinal perforation on Apr 29, 2010 from ITALY Additional patient health information: Male patient , weighting 1.76 lb, was diagnosed with hepatitis c (What is hepatitis c?) and. Enfuvirtide dosage: Another Indication: Hiv Infection. During the same period patient was treated with STAVUDINE (Another Indication: Hiv Infection) (View Stavudine Review and Stavudine Label ), TENOFOVIR (Another Indication: Hiv Infection) (View Tenofovir Review and Tenofovir Label ), RITONAVIR (Another Indication: Hiv Infection) (View Ritonavir Review and Ritonavir Label ), TIPRANAVIR (Another Indication: Hiv Infection) (View Tipranavir Review and Tipranavir Label ), ZIDOVUDINE (Another Indication: Hiv Infection) (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (Another Indication: Hiv Infection) (View Lamivudine Review and Lamivudine Label ).

6723753-6 | Immune Reconstitution Syndrome, Impaired Gastric Emptying, Tuberculosis
Adverse event was reported on Mar 05, 2010 by a Female patient taking Enfuvirtide (View Usage) (Dosage: ) was diagnosed with hiv infection (What is hiv infection?), tuberculosis (What is tuberculosis?) and. Location: UNITED KINGDOM , 34 years of age, Patient experienced the following unwanted or unexpected effects: immune reconstitution syndrome, impaired gastric emptying, tuberculosis (What is tuberculosis?). During the same period patient was treated with EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE (View Emtricitabine/tenofovir Disoproxil Fumarate Review and Emtricitabine/tenofovir Disoproxil Fumarate Label ), EFAVIRENZ (View Efavirenz Review and Efavirenz Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), PIRILENE (View Pirilene Review and Pirilene Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ). Patient was hospitalized and became disabled.

6719511-9 | Acute Respiratory Distress Syndrome, Bone Disorder, Hyperglycaemia, Necrotising Colitis, Premature Baby
on Apr 29, 2010 Male patient from ITALY , weighting 1.76 lb, was diagnosed with hepatitis c (What is hepatitis c?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: acute respiratory distress syndrome, bone disorder, hyperglycaemia, necrotising colitis, premature baby. Enfuvirtide dosage: Another Indication: Hiv Infection. During the same period patient was treated with STAVUDINE (Another Indication: Hiv Infection) (View Stavudine Review and Stavudine Label ), TENOFOVIR DISOPROXIL FUMARATE (Another Indication: Hiv Infection) (View Tenofovir Disoproxil Fumarate Review and Tenofovir Disoproxil Fumarate Label ), RITONAVIR (Another Indication: Hiv Infection) (View Ritonavir Review and Ritonavir Label ), TIPRANAVIR (Another Indication: Hiv Infection) (View Tipranavir Review and Tipranavir Label ), ZIDOVUDINE (Another Indication: Hiv Infection) (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (Another Indication: Hiv Infection) (View Lamivudine Review and Lamivudine Label ).

6640085-5 | Furuncle, Injection Site Reaction, Rash Pustular, Staphylococcal Abscess, Staphylococcal Bacteraemia, Status Epilepticus, Virologic Failure
on Mar 02, 2010 Male patient from FRANCE , 55 years of age, was diagnosed with hiv infection (What is hiv infection?), infection prophylaxis, toxoplasmosis and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: furuncle, injection site reaction, rash pustular, staphylococcal abscess, staphylococcal bacteraemia, status epilepticus, virologic failure. Enfuvirtide dosage: . During the same period patient was treated with CO TRIMOXAZOLE (View Co-trimoxazole Review and Co-trimoxazole Label ), TMC114 (View Tmc114 Review and Tmc114 Label ), PYRIMETHAMINE TAB (View Pyrimethamine Tab Review and Pyrimethamine Tab Label ), SULFADIAZINE (View Sulfadiazine Review and Sulfadiazine Label ), FOLINIC ACID (View Folinic Acid Review and Folinic Acid Label ).

6624761-6 | Nervous System Disorder, Treatment Failure
Patient was taking Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: nervous system disorder, treatment failure on Mar 01, 2010 from NETHERLANDS Additional patient health information: Male patient , 50 years of age, . Enfuvirtide dosage: . During the same period patient was treated with MARAVIROC (View Maraviroc Review and Maraviroc Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ), ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ).

6610350-6 | Hospitalisation
Adverse event was reported on Feb 16, 2010 by a Male patient taking Enfuvirtide (View Usage) (Dosage: Last Dose: 02 Feb 2010) was diagnosed with hiv infection (What is hiv infection?), vitamin supplementation and. Location: UNITED STATES , weighting 215.4 lb, Patient had the following side effects: hospitalisation. During the same period patient was treated with DARUNAVIR (Last Dose On: 01 Feb 2010) (View Darunavir Review and Darunavir Label ), RALTEGRAVIR (Last Dose: 01 Feb 2010.) (View Raltegravir Review and Raltegravir Label ), RITONAVIR (Last Dose On: 02 Feb 2010.) (View Ritonavir Review and Ritonavir Label ), TRICOR (Frequency : Every Day, Approximate Duration Of Use: 23 Month) (View Tricor Review and Tricor Label ), CENTRUM (Frequency : Every Day, Approximate Duration Of Use: 7 Years) (View Centrum Review and Centrum Label ), PREPACOL (View Prepacol Review and Prepacol Label ). Patient was hospitalized.

6583612-9 | Dizziness, Headache, Hospitalisation, Vision Blurred
on Feb 04, 2010 Male patient from UNITED STATES , weighting 215.4 lb, was diagnosed with hiv infection (What is hiv infection?), vitamin supplementation and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: dizziness (What is dizziness?), headache (What is headache?), hospitalisation, vision blurred. Enfuvirtide dosage: Last Dose: 02 Feb 2010. During the same period patient was treated with DARUNAVIR (Last Dose On: 01 Feb 2010) (View Darunavir Review and Darunavir Label ), RALTEGRAVIR (Last Dose: 01 Feb 2010.) (View Raltegravir Review and Raltegravir Label ), RITONAVIR (Last Dose On: 02 Feb 2010.) (View Ritonavir Review and Ritonavir Label ), TRICOR (Frequency : Every Day, Approximate Duration Of Use: 23 Month) (View Tricor Review and Tricor Label ), CENTRUM (Frequency : Every Day, Approximate Duration Of Use: 7 Years) (View Centrum Review and Centrum Label ), PREPACOL (View Prepacol Review and Prepacol Label ). Patient was hospitalized.

6565673-6 | Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia
on Jan 18, 2010 Male patient from UNITED STATES , weighting 147.7 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, cytolytic hepatitis, hypoxia, pyrexia. Enfuvirtide dosage: Form: Oral Solution. During the same period patient was treated with MARAVIROC (View Maraviroc Review and Maraviroc Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), ZELITREX (View Zelitrex Review and Zelitrex Label ), AZADOSE (View Azadose Review and Azadose Label ), EPIVIR (View Epivir Review and Epivir Label ), ISENTRESS (View Isentress Review and Isentress Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), JOSAMYCIN (View Josamycin Review and Josamycin Label ). Patient was hospitalized.

6521434-5 | Appendicitis
Patient was taking Enfuvirtide (View Usage). Patient had the following side effects: appendicitis (What is appendicitis?) on Dec 21, 2009 from CZECH REPUBLIC Additional patient health information: Male patient , 33 years of age, . Enfuvirtide dosage: . During the same period patient was treated with TENOFOVIR (View Tenofovir Review and Tenofovir Label ), TIPRANAVIR (View Tipranavir Review and Tipranavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ). Patient was hospitalized.

6515303-4 | Neurological Symptom
Adverse event was reported on Dec 10, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: Temporarily Held) was diagnosed with hiv infection (What is hiv infection?) and. Location: UNITED STATES , weighting 213.0 lb, After Enfuvirtide was administered, patient had the following side effects: neurological symptom. During the same period patient was treated with RALTEGRAVIR (Temporarily Held) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Temporarily Held) (View Darunavir Review and Darunavir Label ), RITONAVIR (Temporarily Held) (View Ritonavir Review and Ritonavir Label ), ETRAVIRINE (Temporarily Held) (View Etravirine Review and Etravirine Label ), HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label ), DAPSONE (View Dapsone Review and Dapsone Label ), LOPID (View Lopid Review and Lopid Label ), NEURONTIN (View Neurontin Review and Neurontin Label ). Patient was hospitalized.

6515301-0 | Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia
on Dec 11, 2009 Male patient from UNITED STATES , weighting 147.7 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, cytolytic hepatitis, hypoxia, pyrexia. Enfuvirtide dosage: Form: Oral Solution. During the same period patient was treated with MARAVIROC (View Maraviroc Review and Maraviroc Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), ZELITREX (View Zelitrex Review and Zelitrex Label ), AZADOSE (View Azadose Review and Azadose Label ), EPIVIR (View Epivir Review and Epivir Label ), ISENTRESS (View Isentress Review and Isentress Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), JOSAMYCIN (View Josamycin Review and Josamycin Label ). Patient was hospitalized.

6450185-0 | Acute Respiratory Failure, Disturbance In Attention, Hypersensitivity, Lactic Acidosis, Renal Failure, Rhabdomyolysis
on Nov 09, 2009 Female patient from FRANCE , 40 years of age, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: acute respiratory failure, disturbance in attention, hypersensitivity, lactic acidosis, renal failure, rhabdomyolysis. Enfuvirtide dosage: . During the same period patient was treated with ABACAVIR (View Abacavir Review and Abacavir Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ). Patient was hospitalized.

6444209-4 | Immune Reconstitution Syndrome, Impaired Gastric Emptying, Tuberculosis
Patient was taking Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: immune reconstitution syndrome, impaired gastric emptying, tuberculosis (What is tuberculosis?) on Nov 05, 2009 from UNITED KINGDOM Additional patient health information: Female patient , 34 years of age, was diagnosed with hiv infection (What is hiv infection?), tuberculosis (What is tuberculosis?) and. Enfuvirtide dosage: . During the same period patient was treated with EMTRICITABINE/TENOFOVIR (View Emtricitabine/tenofovir Review and Emtricitabine/tenofovir Label ), EFAVIRENZ (View Efavirenz Review and Efavirenz Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), PIRILENE (View Pirilene Review and Pirilene Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ). Patient was hospitalized and became disabled.

6410712-6 | Lung Neoplasm Malignant
Adverse event was reported on Oct 09, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) . Location: POLAND , 51 years of age, Patient experienced the following unwanted or unexpected effects: lung neoplasm malignant. During the same period patient was treated with NELFINAVIR MESYLATE (View Nelfinavir Mesylate Review and Nelfinavir Mesylate Label ), SAQUINAVIR (View Saquinavir Review and Saquinavir Label ), ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ), STAVUDINE (View Stavudine Review and Stavudine Label ), LOPINAVIR (View Lopinavir Review and Lopinavir Label ), FOSAMPRENAVIR (View Fosamprenavir Review and Fosamprenavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ).

6380259-4 | Arteriosclerosis, Organising Pneumonia
on Sep 22, 2009 Male patient from UNITED STATES , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: arteriosclerosis, organising pneumonia. Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2009,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2009,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE/TENOFOVIR (View Emtricitabine/tenofovir Review and Emtricitabine/tenofovir Label ), ACV (View Acv Review and Acv Label ), LAMICTAL (View Lamictal Review and Lamictal Label ), MOTRIN (View Motrin Review and Motrin Label ).

6376698-8 | Escherichia Bacteraemia
on Sep 14, 2009 Male patient from UNITED STATES , 51 years of age, was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: escherichia bacteraemia. Enfuvirtide dosage: . During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ). Patient was hospitalized.

6374000-9 | Diabetic Ketoacidosis
Patient was taking Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: diabetic ketoacidosis on Sep 14, 2009 from UNITED STATES Additional patient health information: Male patient , 49 years of age, . Enfuvirtide dosage: . During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ).

6370243-9 | Arteriosclerosis, Cholestasis, Coronary Artery Stenosis, Fall, Fibrosis, Gastrointestinal Haemorrhage, Hepatic Fibrosis, Nasopharyngitis, Organising Pneumonia
Adverse event was reported on Sep 17, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: Last Dose Prior To Sae: 24 May 2009, Permanently Discontinued.) was diagnosed with hiv infection (What is hiv infection?) and. Location: UNITED STATES , weighting 178.4 lb, Patient had the following side effects: arteriosclerosis, cholestasis, coronary artery stenosis, fall (What is fall?), fibrosis, gastrointestinal haemorrhage, hepatic fibrosis, nasopharyngitis, organising pneumonia. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2009,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2009,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE/TENOFOVIR (View Emtricitabine/tenofovir Review and Emtricitabine/tenofovir Label ), ACV (View Acv Review and Acv Label ), LAMICTAL (View Lamictal Review and Lamictal Label ), MOTRIN (View Motrin Review and Motrin Label ).

6360816-1 | Arteriosclerosis, Fall, Organising Pneumonia, Pain In Extremity, Upper Limb Fracture
on Sep 09, 2009 Male patient from UNITED STATES , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: arteriosclerosis, fall (What is fall?), organising pneumonia, pain in extremity, upper limb fracture. Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Frequency: Sq Bid,permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE (Dose: 500 Mg Qd.) (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (Frequency: Qd) (View Tenofovir Review and Tenofovir Label ), ACV (View Acv Review and Acv Label ).

6333327-7 | Immune Reconstitution Syndrome, Impaired Gastric Emptying, Tuberculosis
on Aug 20, 2009 Female patient from UNITED KINGDOM , 84 years of age, was diagnosed with hiv infection (What is hiv infection?), tuberculosis (What is tuberculosis?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: immune reconstitution syndrome, impaired gastric emptying, tuberculosis (What is tuberculosis?). Enfuvirtide dosage: . During the same period patient was treated with EMTRICITABINE/TENOFOVIR (View Emtricitabine/tenofovir Review and Emtricitabine/tenofovir Label ), EFAVIRENZ (View Efavirenz Review and Efavirenz Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), PIRILENE (View Pirilene Review and Pirilene Label ), RIFAMPICIN (View Rifampicin Review and Rifampicin Label ). Patient was hospitalized and became disabled.

6314791-6 | Pyrexia
Patient was taking Enfuvirtide (View Usage). Patient had the following side effects: pyrexia on Aug 13, 2009 from FRANCE Additional patient health information: Female patient , weighting 99.21 lb, was diagnosed with hiv infection (What is hiv infection?) and. Enfuvirtide dosage: . During the same period patient was treated with SUSTIVA (Frequency Reported As Day) (View Sustiva Review and Sustiva Label ), TRUVADA (View Truvada Review and Truvada Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), BACTRIM (View Bactrim Review and Bactrim Label ), SPECIAFOLDINE (View Speciafoldine Review and Speciafoldine Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), SOLUPRED (View Solupred Review and Solupred Label ). Patient was hospitalized and became disabled.

6303065-5 | Immune Reconstitution Syndrome, Mycobacteria Blood Test Positive, Oesophageal Candidiasis, Renal Failure
Adverse event was reported on Jul 30, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) was diagnosed with prophylaxis, pain (What is pain?) and. Location: FRANCE , weighting 90.39 lb, After Enfuvirtide was administered, patient had the following side effects: immune reconstitution syndrome, mycobacteria blood test positive, oesophageal candidiasis, renal failure. During the same period patient was treated with KALETRA (View Kaletra Review and Kaletra Label ), EPIVIR (View Epivir Review and Epivir Label ), ISENTRESS (Frequency Reported As Tib.) (View Isentress Review and Isentress Label ), ZIAGEN (Frequency Reported As Tib.) (View Ziagen Review and Ziagen Label ), BACTRIM (Total Daily Dose Reported As 400mg/d.) (View Bactrim Review and Bactrim Label ), STILNOX (View Stilnox Review and Stilnox Label ), ACUPAN (View Acupan Review and Acupan Label ). Patient was hospitalized.

6288006-1 |
on Jul 24, 2009 Male patient from UNITED STATES , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). . Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Frequency: Sq Bid,permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE (Dose: 500 Mg Qd.) (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (Frequency: Qd) (View Tenofovir Review and Tenofovir Label ), ACV (View Acv Review and Acv Label ).

6282424-3 |
on Jul 17, 2009 Male patient from UNITED STATES , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). . Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Frequency: Sq Bid,permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE (Dose: 500 Mg Qd.) (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (Frequency: Qd) (View Tenofovir Review and Tenofovir Label ), ACV (View Acv Review and Acv Label ).

6270767-9 | Fall, Injection Site Reaction, Nasopharyngitis, Pain In Extremity
Patient was taking Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: fall (What is fall?), injection site reaction, nasopharyngitis, pain in extremity on Jun 12, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and. Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Frequency: Sq Bid,permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE (Dose: 500 Mg Qd.) (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (Frequency: Qd) (View Tenofovir Review and Tenofovir Label ), ACV (View Acv Review and Acv Label ).

6258822-0 | B-cell Lymphoma
Adverse event was reported on Jun 29, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) . Location: CANADA , 52 years of age, Patient experienced the following unwanted or unexpected effects: b-cell lymphoma. During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ).

6258580-X | Depression, Prostate Cancer
on Jun 29, 2009 Male patient from CANADA , 56 years of age, was treated with Enfuvirtide (View Usage). Patient had the following side effects: depression (What is depression?), prostate cancer (What is prostate cancer?). Enfuvirtide dosage: . During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ).

6241658-4 | Hepatotoxicity, Skin Reaction, Weight Decreased
on Dec 15, 2006 Male patient from GERMANY , 52 years of age, was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: hepatotoxicity, skin reaction, weight decreased. Enfuvirtide dosage: Discontinued For 6 Weeks. During the same period patient was treated with ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ), TIPRANAVIR (View Tipranavir Review and Tipranavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ).

6239459-6 |
Patient was taking Enfuvirtide (View Usage). on Jun 12, 2009 from UNITED STATES Additional patient health information: Male patient , weighting 178.4 lb, was diagnosed with hiv infection (What is hiv infection?) and. Enfuvirtide dosage: Last Dose Prior To Sae: 24 May 2009, Frequency: Sq Bid,permanently Discontinued.. During the same period patient was treated with RALTEGRAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (Last Dose Prior To Sae: 24 May 2008, Frequency: Bid,permanently Discontinued.) (View Darunavir Review and Darunavir Label ), ETRAVIRINE (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Etravirine Review and Etravirine Label ), RITONAVIR (Last Dose Prior To Sae: 24 May 2009, Frequency: Bid,permanently Discontinued.) (View Ritonavir Review and Ritonavir Label ), EMTRICITABINE (Dose: 500 Mg Qd.) (View Emtricitabine Review and Emtricitabine Label ), TENOFOVIR (Frequency: Qd) (View Tenofovir Review and Tenofovir Label ), ACV (View Acv Review and Acv Label ).

6239273-1 | Cd4 Lymphocytes Increased, Immune Reconstitution Syndrome, Mycoplasma Infection, Osteomyelitis, Skin Ulcer
Adverse event was reported on Jun 12, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) . Location: AUSTRALIA , 58 years of age, Patient had the following side effects: cd4 lymphocytes increased, immune reconstitution syndrome, mycoplasma infection, osteomyelitis, skin ulcer. During the same period patient was treated with AZITHROMYCIN (View Azithromycin Review and Azithromycin Label ), DARUNAVIR (View Darunavir Review and Darunavir Label ), PREDNISONE (View Prednisone Review and Prednisone Label ), TRUVADA (View Truvada Review and Truvada Label ). Patient was hospitalized.

6189885-9 | Chest Pain
on May 01, 2009 Female patient from UNITED STATES , weighting 196.2 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: chest pain (What is chest pain?). Enfuvirtide dosage: . During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (View Darunavir Review and Darunavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), LANTUS (Frequency: Hs At Bedtime, Last Dose On 21 April 2009.) (View Lantus Review and Lantus Label ), BACTRIM (Frequency: Qd Every Day, Last Dose On 21 April 2009.) (View Bactrim Review and Bactrim Label ), GARDASIL (Scheduled For 3 Vaccinations: First On 23 Feb 2009, Second Scheduled On 28 April 2009.) (View Gardasil Review and Gardasil Label ), NOVOLOG (Frequency: Before Meals, Last Dose On 21 April 2009.) (View Novolog Review and Novolog Label ). Patient was hospitalized.

6183194-X | Pyrexia
on Apr 23, 2009 Female patient from FRANCE , weighting 83.78 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: pyrexia. Enfuvirtide dosage: . During the same period patient was treated with SUSTIVA (Frequency Reported As Day) (View Sustiva Review and Sustiva Label ), TRUVADA (View Truvada Review and Truvada Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), BACTRIM (View Bactrim Review and Bactrim Label ), SPECIAFOLDINE (View Speciafoldine Review and Speciafoldine Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), SOLUPRED (View Solupred Review and Solupred Label ). Patient was hospitalized and became disabled.

6133548-2 | Anaemia, Blood Triglycerides Increased, Hiv Infection, Injection Site Reaction
Patient was taking Enfuvirtide (View Usage). Patient had the following side effects: anaemia, blood triglycerides increased, hiv infection (What is hiv infection?), injection site reaction on Mar 20, 2009 from NIGERIA Additional patient health information: Female patient , 38 years of age, . Enfuvirtide dosage: . During the same period patient was treated with NELFINAVIR (View Nelfinavir Review and Nelfinavir Label ), ZIDOVUDINE (View Zidovudine Review and Zidovudine Label ), LAMIVUDINE (View Lamivudine Review and Lamivudine Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ), DIDANOSINE (View Didanosine Review and Didanosine Label ), EFAVIRENZ (View Efavirenz Review and Efavirenz Label ), NEVIRAPINE (View Nevirapine Review and Nevirapine Label ), LOPINAVIR (View Lopinavir Review and Lopinavir Label ).

6126038-4 | Neurological Symptom
Adverse event was reported on Mar 10, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: ) was diagnosed with hiv infection (What is hiv infection?) and. Location: UNITED STATES , 44 years of age, After Enfuvirtide was administered, patient had the following side effects: neurological symptom. During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (View Darunavir Review and Darunavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label ), DAPSONE (View Dapsone Review and Dapsone Label ), LOPID (View Lopid Review and Lopid Label ), NEURONTIN (View Neurontin Review and Neurontin Label ). Patient was hospitalized.

6119167-2 | Colitis, Dehydration, Diarrhoea, Immune Reconstitution Syndrome
on Mar 06, 2009 Male patient from FRANCE , weighting 112.4 lb, was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: colitis, dehydration, diarrhoea, immune reconstitution syndrome. Enfuvirtide dosage: . During the same period patient was treated with KALETRA (View Kaletra Review and Kaletra Label ), TRUVADA (View Truvada Review and Truvada Label ), MALOCIDE (View Malocide Review and Malocide Label ), WELLVONE (Tdd: 1500 Daily) (View Wellvone Review and Wellvone Label ). Patient was hospitalized.

6112717-1 | Neurological Symptom
on Mar 02, 2009 Male patient from UNITED STATES , 44 years of age, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: neurological symptom. Enfuvirtide dosage: . During the same period patient was treated with RALTEGRAVIR (View Raltegravir Review and Raltegravir Label ), DARUNAVIR (View Darunavir Review and Darunavir Label ), RITONAVIR (View Ritonavir Review and Ritonavir Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), HYDROCHLOROTHIAZIDE (View Hydrochlorothiazide Review and Hydrochlorothiazide Label ), DAPSONE (View Dapsone Review and Dapsone Label ), LOPID (View Lopid Review and Lopid Label ), NEURONTIN (View Neurontin Review and Neurontin Label ). Patient was hospitalized.

6082332-7 | Pyrexia
Patient was taking Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: pyrexia on Feb 09, 2009 from FRANCE Additional patient health information: Female patient , weighting 90.17 lb, was diagnosed with hiv infection (What is hiv infection?) and. Enfuvirtide dosage: Frequency Reported As 2/day. During the same period patient was treated with SUSTIVA (Frequency Reported As Day) (View Sustiva Review and Sustiva Label ), TRUVADA (View Truvada Review and Truvada Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), BACTRIM (View Bactrim Review and Bactrim Label ), SPECIAFOLDINE (View Speciafoldine Review and Speciafoldine Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), SOLUPRED (View Solupred Review and Solupred Label ). Patient was hospitalized and became disabled.

6079295-7 | Blood Creatine Phosphokinase Increased, Cytolytic Hepatitis, Hypoxia, Pyrexia
Adverse event was reported on Feb 02, 2009 by a Male patient taking Enfuvirtide (View Usage) (Dosage: Form: Oral Solution) was diagnosed with hiv infection (What is hiv infection?) and. Location: UNITED STATES , weighting 147.7 lb, Patient experienced the following unwanted or unexpected effects: blood creatine phosphokinase increased, cytolytic hepatitis, hypoxia, pyrexia. During the same period patient was treated with MARAVIROC (View Maraviroc Review and Maraviroc Label ), BACTRIM DS (View Bactrim Ds Review and Bactrim Ds Label ), ZELITREX (View Zelitrex Review and Zelitrex Label ), AZADOSE (View Azadose Review and Azadose Label ), EPIVIR (View Epivir Review and Epivir Label ), ISENTRESS (View Isentress Review and Isentress Label ), ETRAVIRINE (View Etravirine Review and Etravirine Label ), JOSAMYCIN (View Josamycin Review and Josamycin Label ). Patient was hospitalized.

6077695-2 | Pyrexia
on Feb 04, 2009 Female patient from FRANCE , weighting 90.17 lb, was diagnosed with hiv infection (What is hiv infection?) and was treated with Enfuvirtide (View Usage). Patient had the following side effects: pyrexia. Enfuvirtide dosage: Frequency Reported As 2/day. During the same period patient was treated with SUSTIVA (Frequency Reported As Day) (View Sustiva Review and Sustiva Label ), TRUVADA (View Truvada Review and Truvada Label ), RIFATER (View Rifater Review and Rifater Label ), MYAMBUTOL (View Myambutol Review and Myambutol Label ), BACTRIM (View Bactrim Review and Bactrim Label ), SPECIAFOLDINE (View Speciafoldine Review and Speciafoldine Label ), SOLU MEDROL (View Solu-medrol Review and Solu-medrol Label ), SOLUPRED (View Solupred Review and Solupred Label ). Patient was hospitalized and became disabled.

5983948-6 | Abortion Spontaneous
on Nov 24, 2008 Female patient from UNITED STATES , 38 years of age, weighting 127.0 lb, was diagnosed with hiv infection (What is hiv infection?), antiviral prophylaxis, post-traumatic stress disorder (What is post-traumatic stress disorder?), neuropathy peripheral and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: abortion spontaneous. Enfuvirtide dosage: . During the same period patient was treated with TMC 125 (View Tmc 125 Review and Tmc 125 Label ), KALETRA (Patient Received 8 Capsules (133.3 / 33.3 Mg Formulary) During Pregnancy) (View Kaletra Review and Kaletra Label ), NAPROXEN (View Naproxen Review and Naproxen Label ), CALCIUM (View Calcium Review and Calcium Label ), VIREAD (View Viread Review and Viread Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), CITALOPRAM HYDROBROMIDE (View Citalopram Hydrobromide Review and Citalopram Hydrobromide Label ), METHADONE HCL (View Methadone Hcl Review and Methadone Hcl Label ).

5976025-1 | Abortion Spontaneous
Patient was taking Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: abortion spontaneous on Nov 24, 2008 from UNITED STATES Additional patient health information: Female patient , 38 years of age, weighting 127.0 lb, was diagnosed with hiv infection (What is hiv infection?), antiviral prophylaxis, post-traumatic stress disorder (What is post-traumatic stress disorder?), neuropathy peripheral and. Enfuvirtide dosage: . During the same period patient was treated with TMC 125 (View Tmc 125 Review and Tmc 125 Label ), KALETRA (Patient Received 8 Capsules (133.3 / 33.3 Mg Formulary) During Pregnancy) (View Kaletra Review and Kaletra Label ), NAPROXEN (View Naproxen Review and Naproxen Label ), CALCIUM (View Calcium Review and Calcium Label ), VIREAD (View Viread Review and Viread Label ), ACYCLOVIR (View Acyclovir Review and Acyclovir Label ), CITALOPRAM HYDROBROMIDE (View Citalopram Hydrobromide Review and Citalopram Hydrobromide Label ), METHADONE HCL (View Methadone Hcl Review and Methadone Hcl Label ).

5965647-X | Oesophageal Candidiasis
Adverse event was reported on Nov 18, 2008 by a Female patient taking Enfuvirtide (View Usage) (Dosage: ) . Location: FRANCE , weighting 85.98 lb, Patient had the following side effects: oesophageal candidiasis. During the same period patient was treated with KALETRA (View Kaletra Review and Kaletra Label ), TRUVADA (View Truvada Review and Truvada Label ), BACTRIM (View Bactrim Review and Bactrim Label ), ATARAX (View Atarax Review and Atarax Label ), PRIMPERAN (View Primperan Review and Primperan Label ), IMODIUM (View Imodium Review and Imodium Label ). Patient was hospitalized.

5965645-6 | Ascites, Candidiasis, Cardiac Tamponade, Cytomegalovirus Test, Renal Failure Acute
on Oct 20, 2008 Male patient from ITALY , 46 years of age, was diagnosed with hiv infection (What is hiv infection?), prophylaxis and was treated with Enfuvirtide (View Usage). After Enfuvirtide was administered, patient had the following side effects: ascites, candidiasis, cardiac tamponade, cytomegalovirus test, renal failure acute. Enfuvirtide dosage: . During the same period patient was treated with SULFAMETHOXAZOLE AND TRIMETHOPRIM (View Sulfamethoxazole And Trimethoprim Review and Sulfamethoxazole And Trimethoprim Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), CYCLOSPORINE (150 + 150 Mg) (View Cyclosporine Review and Cyclosporine Label ), STEROID NOS (View Steroid Nos Review and Steroid Nos Label ), FOSAMPRENAVIR (View Fosamprenavir Review and Fosamprenavir Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ).

5958481-8 | Oesophageal Candidiasis
on Nov 13, 2008 Female patient from FRANCE , weighting 85.98 lb, was treated with Enfuvirtide (View Usage). Patient experienced the following unwanted or unexpected effects: oesophageal candidiasis. Enfuvirtide dosage: . During the same period patient was treated with KALETRA (View Kaletra Review and Kaletra Label ), TRUVADA (View Truvada Review and Truvada Label ), BACTRIM (View Bactrim Review and Bactrim Label ), ATARAX (View Atarax Review and Atarax Label ), PRIMPERAN (View Primperan Review and Primperan Label ), IMODIUM (View Imodium Review and Imodium Label ). Patient was hospitalized.

5937894-4 | Ascites, Candidiasis, Cardiac Tamponade, Cytomegalovirus Test, Renal Failure Acute
Patient was taking Enfuvirtide (View Usage). Patient had the following side effects: ascites, candidiasis, cardiac tamponade, cytomegalovirus test, renal failure acute on Oct 20, 2008 from ITALY Additional patient health information: Male patient , 46 years of age, was diagnosed with hiv infection (What is hiv infection?), prophylaxis and. Enfuvirtide dosage: . During the same period patient was treated with SULFAMETHOXAZOLE AND TRIMETHOPRIM (View Sulfamethoxazole And Trimethoprim Review and Sulfamethoxazole And Trimethoprim Label ), GANCICLOVIR (View Ganciclovir Review and Ganciclovir Label ), CYCLOSPORINE (150 + 150 Mg) (View Cyclosporine Review and Cyclosporine Label ), STEROID NOS (View Steroid Nos Review and Steroid Nos Label ), FOSAMPRENAVIR (View Fosamprenavir Review and Fosamprenavir Label ), TENOFOVIR (View Tenofovir Review and Tenofovir Label ).