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Norvir (Ritonavir) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the labeling.

  • Drug Interactions [see Warnings and Precautions ]
  • Hepatotoxicity [see Warnings and Precautions ]
  • Pancreatitis [see Warnings and Precautions ]
  • Allergic Reactions/Hypersensitivity [see Warnings and Precautions ]

When co-administering NORVIR with other protease inhibitors, see the full prescribing information for that protease inhibitor including adverse reactions.

Adult Clinical Trial Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of NORVIR alone and in combination with other antiretroviral agents was studied in 1,755 adult patients. Table 2 lists treatment-emergent Adverse Reactions (with possible or probable relationship to study drug) occurring in greater than or equal to 1% of adult patients receiving NORVIR in combined Phase II/IV studies.

The most frequently reported adverse drug reactions among patients receiving NORVIR alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia.

Table 2. Treatment-Emergent Adverse Reactions (With Possible or Probable Relationship to Study Drug) Occurring in greater than or equal to 1% of Adult Patients Receiving NORVIR in Combined Phase II/IV Studies (N = 1,755)
Adverse Reactions n %
Eye disorders
            Blurred vision 113 6.4
Gastrointestinal disorders
           Abdominal Pain (upper and lower)* 464 26.4
           Diarrhea including severe with electrolyte imbalance* 1,192 67.9
           Dyspepsia 201 11.5
           Flatulence 142 8.1
           Gastrointestinal hemorrhage* 41 2.3
           Gastroesophageal reflux disease (GERD) 19 1.1
           Nausea 1,007 57.4
           Vomiting* 559 31.9
General disorders and administration site conditions
           Fatigue including asthenia* 811 46.2
Hepatobiliary disorders
           Blood bilirubin increased (including jaundice)* 25 1.4
           Hepatitis (including increased AST, ALT, GGT)* 153 8.7
Immune system disorders
          Hypersensivity including urticatria and face edema* 114 8.2
Metabolism and nutrition disorders
           Edema and peripheral edema* 110 6.3
           Gout* 24 1.4
           Hypercholesterolemia* 52 3.0
           Hypertriglyceridemia* 158 9.0
           Lipodystrophy acquired* 51 2.9
Musculoskeletal and connective tissue disorders
           Arthralgia and back pain* 326 18.6
           Myopathy/creatine phosphokinase increased* 66 3.8
           Myalgia 156 8.9
Nervous system disorders
           Dizziness* 274 15.6
           Dysgeusia* 285 16.2
           Paresthesia (including oral paresthesia)* 889 50.7
           Peripheral neuropathy 178 10.1
           Syncope* 58 3.3
Psychiatric disorders
           Confusion* 52 3.0
           Disturbance in attention 44 2.5
Renal and urinary disorders
           Increased urination* 74 4.2
Respiratory, thoracic and mediastinal disorders
          Coughing* 380 21.7
          Oropharyngeal Pain* 279 15.9
Skin and subcutaneous tissue disorders
           Acne* 67 3.8
           Pruritus* 214 12.2
           Rash (includes erythematous and maculopapular)*  475 27.1
Vascular disorders
           Flushing, feeling hot* 232 13.2
           Hypertension* 58 3.3
           Hypotension including orthostatic hypotension* 30 1.7
           Peripheral coldness* 21 1.2
* Represents a medical concept including several similar MedDRA PTs

Laboratory Abnormalities

Table 3 shows the percentage of adult patients who developed marked laboratory abnormalities.

-   Indicates no events reported.
Table 3. Percentage of Adult Patients, by Study and Treatment Group, with Chemistry and Hematology Abnormalities
Occurring in greater than 3% of Patients Receiving NORVIR
    Study 245
Naive Patients
Study 247
Advanced Patients
Study 462
PI-Naive Patients
Variable Limit NORVIR plus
ZDV
NORVIR ZDV NORVIR Placebo NORVIR plus
Saquinavir
Chemistry High  
Cholesterol > 240 mg/dL 30.7 44.8 9.3 36.5 8.0 65.2
CPK > 1000 IU/L 9.6 12.1 11.0 9.1 6.3 9.9
GGT > 300 IU/L 1.8 5.2 1.7 19.6 11.3 9.2
SGOT (AST) > 180 IU/L 5.3 9.5 2.5 6.4 7.0 7.8
SGPT (ALT) > 215 IU/L 5.3 7.8 3.4 8.5 4.4 9.2
Triglycerides > 800 mg/dL 9.6 17.2 3.4 33.6 9.4 23.4
Triglycerides > 1500 mg/dL 1.8 2.6 - 12.6 0.4 11.3
Triglycerides Fasting > 1500 mg/dL 1.5 1.3 - 9.9 0.3 -
Uric Acid > 12 mg/dL - - - 3.8 0.2 1.4
Hematology Low  
Hematocrit < 30% 2.6 - 0.8 17.3 22.0 0.7
Hemoglobin < 8.0 g/dL 0.9 - - 3.8 3.9 -
Neutrophils ≤ 0.5 x 109/L - - - 6.0 8.3 -
RBC < 3.0 x 1012/L 1.8 - 5.9 18.6 24.4 -
WBC < 2.5 x 109/L - 0.9 6.8 36.9 59.4 3.5

Pediatric Clinical Trial Experience

NORVIR has been studied in 265 pediatric patients greater than 1 month to 21 years of age. The adverse event profile observed during pediatric clinical trials was similar to that for adult patients.

Vomiting, diarrhea, and skin rash/allergy were the only drug-related clinical adverse events of moderate to severe intensity observed in greater than or equal to 2% of pediatric patients enrolled in NORVIR clinical trials.

Laboratory Abnormalities

The following Grade 3-4 laboratory abnormalities occurred in greater than 3% of pediatric patients who received treatment with NORVIR either alone or in combination with reverse transcriptase inhibitors: neutropenia (9%), hyperamylasemia (7%), thrombocytopenia (5%), anemia (4%), and elevated AST (3%).

Postmarketing Experience

The following adverse events have been reported during post-marketing use of NORVIR. Because these reactions are reported voluntarily from a population of unknown size, it is not possible to reliably estimate their frequency or establish a causal relationship to NORVIR exposure.

Body as a Whole

Dehydration, usually associated with gastrointestinal symptoms, and sometimes resulting in hypotension, syncope, or renal insufficiency has been reported. Syncope, orthostatic hypotension, and renal insufficiency have also been reported without known dehydration.

Co-administration of ritonavir with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system.

Cardiovascular System

First-degree AV block, second-degree AV block, third-degree AV block, right bundle branch block have been reported [see Warnings and Precautions ].

Cardiac and neurologic events have been reported when ritonavir has been co-administered with disopyramide, mexiletine, nefazodone, fluoxetine, and beta blockers. The possibility of drug interaction cannot be excluded.

Endocrine System

Cushing's syndrome and adrenal suppression have been reported when ritonavir has been co-administered with fluticasone propionate or budesonide.

Nervous System

There have been postmarketing reports of seizure. Also, see Cardiovascular System.

Skin and subcutaneous tissue disorders

Toxic epidermal necrolysis (TEN) has been reported.



REPORTS OF SUSPECTED NORVIR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Norvir. The information is not vetted and should not be considered as verified clinical evidence.

Possible Norvir side effects / adverse reactions in 38 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: 38 year old female

Reactions: in Vitro Fertilisation, Abortion Spontaneous, Generalised Oedema

Suspect drug(s):
Reyataz
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2007-12-21
    End date: 2011-01-01

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2007-12-21
    End date: 2011-01-01

Tenofovir Disoproxil Fumarate
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2007-12-21
    End date: 2011-07-01



Possible Norvir side effects / adverse reactions in 38 year old male

Reported by a physician from Germany on 2011-10-05

Patient: 38 year old male weighing 71.7 kg (157.7 pounds)

Reactions: Pneumocystis Jiroveci Pneumonia

Adverse event resulted in: hospitalization

Suspect drug(s):
Norvir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-11

Darunavir Ethanolate
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-11

Raltegravir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2011-04-11



Possible Norvir side effects / adverse reactions in 62 year old male

Reported by a physician from France on 2011-10-05

Patient: 62 year old male

Reactions: Condition Aggravated, Haematoma

Adverse event resulted in: hospitalization

Suspect drug(s):
Truvada
    Administration route: Oral
    Start date: 2010-12-01

Reyataz
    Administration route: Oral
    Start date: 2011-08-13

Prezista
    Administration route: Oral
    Start date: 2011-05-13
    End date: 2011-08-13

Norvir
    Administration route: Oral
    Start date: 2011-05-13
    End date: 2011-08-13

Other drugs received by patient: Herbal Mixture



See index of all Norvir side effect reports >>

Drug label data at the top of this Page last updated: 2013-11-19

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