OpenClaim

Givosiran Side Effects

The most commonly reported side effects of givosiran include porphyria acute, hospitalisation, and nausea, based on 1,312 FDA adverse event reports from 2020 to 2025. 3.3% of reports found the drug to be ineffective.

Givosiran side effects

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

1
Porphyria Acute31.4%412
2
Hospitalisation11.7%153
3
Nausea7.3%96
4
Product Dose Omission Issue7.3%96
5
Fatigue6.9%90
6
Therapy Interrupted6.7%88
7
Pain6.0%79
8
Intentional Dose Omission5.5%72
9
Abdominal Pain4.8%63
10
Malaise4.7%62
11
Vomiting4.6%61
12
Ill-defined Disorder4.0%52
13
Seizure3.8%50
14
Drug Ineffective3.3%43
15
Weight Decreased3.2%42

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

Report severity

74.8%Serious981 reports
48.4%Hospitalizations635 reports
2.7%Fatal35 reports

Seriousness is determined by the reporter, not by OpenClaim.

Givosiran drug interactions

Other drugs that appear in adverse event reports alongside givosiran. 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
Amlodipine0.4%5
2
Lisinopril0.2%3
3
Promethazine-hydrochloride0.2%3
4
Gabapentin0.2%3
5
Metoclopramide-hydrochloride0.2%3
6
Erythromycin0.2%3
7
Cimetidine0.2%3
8
Ranitidine0.2%3
9
Lubiprostone0.2%2
10
Spironolactone0.2%2
11
Dupilumab0.2%2
12
Citalopram-hydrobromide<0.1%1
13
Fluoxetine-hydrochloride<0.1%1
14
Leuprolide<0.1%1
15
Degarelix-acetate<0.1%1

Taken alongside

1
Ondansetron4.1%54
2
Acetaminophen3.4%44
3
Epinephrine2.5%33
4
Hydromorphone-hydrochloride2.4%31
5
Gabapentin2.4%31
6
Omeprazole2.4%31
7
Ergocalciferol2.3%30
8
Albuterol2.2%29
9
Lorazepam2.0%26
10
Pantoprazole-sodium1.9%25
11
Cyanocobalamin1.9%25
12
Oxycodone1.8%23
13
Levothyroxine-sodium1.6%21
14
Magnesium-acetate-tetrahydrate1.5%20
15
Apixaban1.4%18

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 givosiran side effects

3.2% of givosiran adverse event reports involve female patients and 0.3% involve male patients. The largest age group is adult at 88%. These figures reflect who reports side effects, not underlying risk.

Sex

Female3.2%
Male0.3%
Unknown96.5%

Age group

< 20.0%
2–111.7%
12–170.0%
18–6488.3%
65+10.0%

What is givosiran used for

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

Carcinoid SyndromeEpilepsyHereditary Neuropathic AmyloidosisIll-defined DisorderMineral Metabolism DisorderNerve InjuryPorphyriaPorphyria AcuteProduct Used For Unknown IndicationPorphyriaPorphyria AcutePorphyria Non-acuteProduct Used For Unknown IndicationProphylaxisQuadriplegia

Showing 15 of 17 indications

Givosiran brand names and reporting trend

Givosiran is sold under the brand name Givlaari.

Brand names

Givlaari18

Quarterly reports (20202025)

2020202220242025

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

Taking givosiran with another medication?

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