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Saquinavir Side Effects

The most commonly reported side effects of saquinavir include lipodystrophy acquired, eyelid ptosis, and mitochondrial toxicity, based on 2,517 FDA adverse event reports from 2004 to 2025.

Saquinavir side effects

Percentages show how often each reaction appears relative to total reports for saquinavir.

1
Lipodystrophy Acquired7.7%195
2
Eyelid Ptosis7.0%175
3
Mitochondrial Toxicity6.8%171
4
Diplopia6.6%167
5
Foetal Exposure During Pregnancy4.8%122
6
Drug Exposure During Pregnancy4.7%119
7
Dysphagia4.2%106
8
Viral Mutation Identified3.7%93
9
Pain3.5%88
10
Emotional Distress3.5%87
11
Anxiety3.4%86
12
Drug Resistance3.4%85
13
Pathogen Resistance3.4%85
14
Virologic Failure3.2%80
15
Progressive External Ophthalmoplegia3.0%76

These are voluntary reports and do not establish that saquinavir caused these reactions.

Report severity

95.8%Serious2,411 reports
33.7%Hospitalizations847 reports
10.2%Fatal256 reports

Seriousness is determined by the reporter, not by OpenClaim.

Saquinavir drug interactions

Other drugs that appear in adverse event reports alongside saquinavir. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Ritonavir55.9%1,408
2
Lamivudine46.8%1,178
3
Zidovudine40.0%1,007
4
Tenofovir34.1%859
5
Stavudine31.5%792
6
Didanosine28.4%716
7
Lopinavir25.5%643
8
Abacavir23.3%587
9
Nevirapine22.1%556
10
Efavirenz20.1%507
11
Indinavir-sulfate18.4%464
12
Nelfinavir-mesylate16.7%421
13
Emtricitabine16.1%405
14
Enfuvirtide11.9%300
15
Atazanavir-sulfate11.5%289

Taken alongside

1
Ritonavir20.2%508
2
Lamivudine15.9%399
3
Tenofovir11.0%276
4
Zidovudine10.4%262
5
Lopinavir7.9%198
6
Abacavir7.1%179
7
Emtricitabine7.0%175
8
Sulfamethoxazole6.9%173
9
Didanosine6.3%158
10
Trimethoprim6.2%155
11
Stavudine5.8%147
12
Atazanavir-sulfate5.0%126
13
Efavirenz4.7%119
14
Nelfinavir-mesylate4.7%118
15
Raltegravir-potassium4.7%118

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports saquinavir side effects

26.5% of saquinavir adverse event reports involve female patients and 59.5% involve male patients. The largest age group is adult at 86%. These figures reflect who reports side effects, not underlying risk.

Sex

Female26.5%
Male59.5%
Unknown14.0%

Age group

< 25.8%
2–111.6%
12–172.0%
18–6486.1%
65+4.5%

What is saquinavir used for

Conditions and purposes for which patients were taking saquinavir when the adverse event was reported.

Acquired Immunodeficiency SyndromeAcute Hiv InfectionAdverse EventAntiretroviral TherapyAntiviral ProphylaxisAntiviral TreatmentAspergillus InfectionAsymptomatic Hiv InfectionAcquired Immunodeficiency SyndromeAntiretroviral TherapyAntiviral TreatmentBone DisorderCd4 Lymphocytes DecreasedChronic Hepatitis CChronic Hepatitis C

Showing 15 of 54 indications

Saquinavir brand names and reporting trend

Saquinavir is sold under brand names including Fortovase, Invirase.

Brand names

Fortovase1,676
Invirase38

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking saquinavir with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.