Side effect information for Tesamorelin

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Side effect	Data for drug	Placebo	Labels
			1	2	3
Arthralgia	13.3%	11%	x	x	x
Injection site reaction	1.3% - 4.6%	0.8%	x	x	x
Nausea	4.4%	3.8%	x	x	x
Injection site pain	4.1%	3%	x	x	x
Rash	3.7%	1.5%	x	x	x
Pain in extremity	0.7% - 6.1%	4.6%	x	x	x
Injection site irritation	2.9%	1.1%	x	x	x
Mental disorder	2%	1.5%	x	x	x
Vomiting	0.7% - 2.6%	0%	x	x	x
Oedema peripheral	0% - 6.1%	2.3%	x	x	x
Injection site pruritus	0% - 7.6%	0.8%	x	x	x
Depression	0.7% - 2%	1.5%	x	x	x
Musculoskeletal pain	1.8%	0.8%	x	x	x
Dyspepsia	1.7%	0.8%	x	x	x
Pain	1.7%	1.1%	x	x	x
Injection site haemorrhage	1.7%	0.4%	x	x	x
Injection site urticaria	1.7%	0.4%	x	x	x
Musculoskeletal stiffness	1.7%	0.4%	x	x	x
Hypoaesthesia	0.7% - 4.2%	1.5%	x	x	x
Paraesthesia	1.5% - 4.8%	2.3%	x	x	x
Neuropathy peripheral	1.5% - 1.6%		x	x	x
Carpal tunnel syndrome	1.5%	0%	x	x	x
Injection site swelling	1.5%	0.4%		x	x
Joint stiffness	1.5%	0.8%	x	x	x
Blood creatine phosphokinase increased	1.5%	0.4%	x	x	x
Hypertension	1.3% - 1.6%	0.8%	x	x	x
Gastrointestinal disorder	0.7% - 2%		x	x	x
Angiopathy	1.3%	0.8%	x	x	x
Pruritus	0.7% - 2.4%	1.1%	x	x	x
Myalgia	0% - 5.5%	1.9%	x	x	x
Injection site erythema	0% - 8.5%	2.7%	x	x	x
Chest pain	1.1%	0.8%	x	x	x
Cardiac disorder	1.1%	0.4%	x	x	x
Night sweats	0% - 1.2%	0.4%	x	x	x
Palpitations	1.1%	0.4%	x	x	x
Muscle spasms	1.1%	0.8%	x	x	x
Muscle strain	1.1%	0%	x	x	x
Joint swelling	1.1%	0%	x	x	x
Abdominal pain upper	1.1%	0.8%	x	x	x
Injection site dermatitis	1.1%	0%	x	x	x
Hot flush	0.7% - 1.2%		x	x	x
Urticaria	0% - 1.2%		x	x	x
Insomnia	0% - 1.2%		x	x	x
Connective tissue disorder			x	x	x
Haemorrhage			x	x	x
Hyperglycaemia			x	x	x
Nervous system disorder			x	x	x
Swelling			x	x	x
Unspecified disorder of skin and subcutaneous tissue			x	x	x
Antibody test positive			x	x	x

Information about indications was extracted from the indications and usage sections of the labels.

Indication			Labels
Hypersensitivity			x	x	x
Lipodystrophy			x	x	x

Side effects:	49
Source:	FDA Structured Product Label

Side effects:	50
Source:	FDA Structured Product Label

Side effects:	50
Source:	FDA Structured Product Label

standard – alternative

Tesamorelin