Side effect information for Baclofen

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term	Side effect	Data for drug	Labels
			1	2	3	4	5	6	7	8	9	10	11	12	13
Somnolence	Drowsiness	11% - 10-63%	x	x	x	x	x	x			x	x			x
Somnolence	Somnolence	very common, 5.7% - 20.9%							x	x	x	x	x	x	x
Hypotonia	Hypotonia	very common, 2% - 34.7%									x	x	x	x	x
Muscle relaxant therapy	Hypotonia	very common, 2% - 34.7%									x	x	x	x	x
Dizziness	Dizziness	common, 1.7% - 12%	x	x	x	x	x	x	x	x	x	x	x	x	x
	Lightheadedness	common, 5% - 12%							x		x	x			x
	Syncope	rare	x	x	x	x	x	x	x	x			x	x	x
Nausea	Nausea	uncommon — 1.4% - 10.5%	x	x	x	x	x	x	x	x	x	x	x	x	x
Confusional state	Confusional state	common, 0.5% - 1-11%	x	x	x	x	x	x	x	x	x	x	x	x	x
Feeling abnormal	Confusional state	common, 0.5% - 1-11%	x	x	x	x	x	x	x	x	x	x	x	x	x
Feeling abnormal	Malaise												x	x	x
Headache	Headache	uncommon — 0% - 10.7%	x	x	x	x	x	x	x	x	x	x	x	x	x
Ataxia	Ataxia	uncommon, common		x	x	x	x	x	x	x	x	x	x	x	x
Cardiac output decreased	Cardiac output decreased	common							x	x
Dysuria	Dysuria	common		x	x	x	x	x	x	x
Dysuria	Urination impaired	0% - 2%									x	x	x	x	x
Enuresis	Enuresis	common		x	x	x	x	x	x	x
Dermatitis	Rash	common	x	x	x	x	x	x	x	x			x	x	x
Rash	Rash	common	x	x	x	x	x	x	x	x			x	x	x
Gastrointestinal disorder	Gastrointestinal disorder	common							x	x		x
Gastrointestinal disorder	Digestion impaired	common							x
Hyperhidrosis	Hyperhidrosis	uncommon, common							x	x		x
	Sweating increased	uncommon	x	x	x	x	x	x			x
	Sweating												x	x	x
Nightmare	Nightmare	common							x	x
Nystagmus	Nystagmus	uncommon, common		x	x	x	x	x	x	x	x		x	x	x
Tinnitus	Tinnitus	common		x	x	x	x	x	x	x			x	x	x
Vertigo	Vertigo	common							x	x
Vomiting	Vomiting	uncommon — 1.6% - 10.5%		x	x	x	x	x	x	x	x	x	x	x	x
Fatigue	Lassitude	common							x
	Exhaustion	common							x
	Fatigue	common, 2-4%	x	x	x	x	x	x		x	x
Muscular weakness	Muscular weakness	common, very common							x	x	x
Accommodation disorder	Accommodation disorder	common										x	x	x	x
Myalgia	Myalgia	common		x	x	x	x	x	x	x
Musculoskeletal discomfort	Myalgia	common		x	x	x	x	x	x	x
Respiratory rate decreased	Respiratory rate decreased	common									x	x
Chest discomfort	Chest tightness	common									x
Dyspepsia	Digestion impaired	common							x
Dyspepsia	Dyspepsia												x	x	x
Decreased appetite	Decreased appetite	common									x	x
Decreased appetite	Anorexia	rare, 0% - 0.9%		x	x	x	x	x	x	x			x	x	x
Retching	Retching	common							x	x
Disorientation	Disorientation	common									x	x
Respiratory depression	Respiratory depression	common							x	x	x	x
Pulmonary function test decreased	Respiratory depression	common							x	x	x	x
Euphoric mood	Euphoric mood	uncommon, common		x	x	x	x	x	x	x	x	x	x	x	x
Personality change	Personality change	common							x	x
Bladder pain	Bladder spasm	common									x
Bladder spasm	Bladder spasm	common									x
Visual impairment	Visual disturbance	common							x
	Visual impairment	common								x
	Abnormal vision												x	x	x
Sexual dysfunction	Sexual dysfunction	common									x	x
Insomnia	Insomnia	common, 0% - 10%	x	x	x	x	x	x	x	x	x	x	x	x	x
Hypotension	Hypotension	common, 0% - 5%	x	x	x	x	x	x	x	x	x	x	x	x	x
Constipation	Constipation	common, 0% - 5.1%	x	x	x	x	x	x	x	x	x	x	x	x	x
Pollakiuria	Pollakiuria	common, 0% - 10%	x	x	x	x	x	x	x	x			x	x	x
Vision blurred	Vision blurred	common, 0% - 5%		x	x	x	x	x			x	x
Convulsion	Convulsion	uncommon — 0.5% - 11%							x	x	x	x	x	x	x
Asthenia	Fatigue	common, 2-4%	x	x	x	x	x	x		x	x
Asthenia	Asthenia	common, 0% - 15%	x	x	x	x	x	x			x	x	x	x	x
Salivary hypersecretion	Salivary hypersecretion	common, 0% - 2.7%									x	x	x	x	x
Paraesthesia	Paraesthesia	rare, 0.654% - 6.7%		x	x	x	x	x	x		x	x	x	x	x
Paraesthesia	Tingling sensation	1% - 8%									x	x
Hypoaesthesia	Numbness	1% - 8%									x	x
Sensory loss	Numbness	1% - 8%									x	x
Pruritus	Pruritus	common, 0% - 8%	x	x	x	x	x	x	x	x	x	x	x	x	x
Urinary retention	Urinary retention	rare — 0.7% - 8%		x	x	x	x	x	x	x	x	x	x	x	x
Hypoxia	Hypoventilation	0.2% - 4%									x	x	x	x	x
Respiratory failure	Hypoventilation	0.2% - 4%									x	x	x	x	x
Hypoventilation	Hypoventilation	0.2% - 4%									x	x	x	x	x
Lethargy	Lethargy	common, 0% - 4%									x	x
Dysarthria	Slurred speech	common, 0% - 6%		x	x	x	x	x			x	x
Dysarthria	Dysarthria	rare		x	x	x	x	x	x	x		x
Back pain	Back pain	0.654% - 2%									x	x	x	x	x
Tremor	Tremor	common, 0% - 1.33%		x	x	x	x	x	x	x	x	x	x	x	x
Diarrhoea	Diarrhoea	common, 0% - 2.3%		x	x	x	x	x	x	x	x	x	x	x	x
Urinary incontinence	Urinary incontinence	common, 0% - 2%									x	x	x	x	x
Hypertonia	Hypertonia	common, 0% - 6%									x	x	x	x	x
Thinking abnormal	Thinking abnormal	0.474% - 1.31%									x	x	x	x	x
Mental disability	Thinking abnormal	0.474% - 1.31%									x	x	x	x	x
Pain	Pain	common, 0% - 4%									x	x	x	x	x
Speech disorder	Speech disorder	0% - 3.5%											x	x	x
Alopecia	Alopecia	uncommon									x	x	x	x	x
Cerebrovascular disorder	Cerebrovascular disorder	uncommon									x
Dysphagia	Dysphagia	uncommon									x	x	x	x	x
Dehydration	Dehydration	uncommon									x	x	x	x	x
Flushing	Flushing	uncommon									x	x
Subdural haematoma	Subdural haematoma	uncommon									x
Hypertension	Hypertension	uncommon, 0.2% - 2%									x	x	x	x	x
Muscle spasticity	Muscle spasticity	uncommon, common									x	x
Pallor	Pallor	uncommon									x	x	x	x	x
Sepsis	Septicemia	uncommon									x
Suicide attempt	Suicide attempt	uncommon									x	x
Weight decreased	Weight decreased	uncommon									x		x	x	x
Deep vein thrombosis	Deep vein thrombosis	uncommon									x	x
Hypogeusia	Hypogeusia	uncommon									x	x
Dysphoria	Dysphoria	uncommon									x	x
Memory impairment	Memory impairment	uncommon										x
Suicidal ideation	Suicidal ideation	uncommon									x	x
Bradycardia	Bradycardia	uncommon							x	x	x	x	x	x	x
Amnesia	Memory loss	uncommon									x
Amnesia	Amnesia												x	x	x
Ileus	Ileus	uncommon									x	x	x	x	x
Psychotic disorder	Paranoia	uncommon									x	x
Paranoia	Paranoia	uncommon									x	x
Paranoia	Paranoid reaction												x	x	x
Coma	Coma	rare, 0% - 4%							x	x	x	x	x	x	x
Body temperature increased	Body temperature increased	common, 0.2% - 0.7%									x	x	x	x	x
Hallucination	Hallucination	uncommon — 0.3% - 0.5%		x	x	x	x	x	x	x	x	x	x	x	x
Dry mouth	Dry mouth	common, 0% - 3.3%		x	x	x	x	x		x	x	x	x	x	x
Chills	Chills	common, 0% - 1.33%									x	x	x	x	x
Agitation	Agitation	common, 0% - 1.33%									x	x	x	x	x
Agitation	Excitement			x	x	x	x	x
Anxiety	Anxiety	common, 0.2% - 0.9%									x	x	x	x	x
Diplopia	Diplopia	common, 0% - 0.9%		x	x	x	x	x			x	x	x	x	x
Dyspnoea	Dyspnoea	rare — 0% - 2%	x	x	x	x	x	x	x	x	x	x	x	x	x
Autonomic nervous system imbalance	Dysautonomia	0.2% - 0.9%											x	x	x
Pneumonia	Pneumonia	common, 0% - 2%									x	x	x	x	x
Urticaria	Urticaria	common, 0.2% - 1.2%							x	x	x	x	x	x	x
Injury	Accidental injury	uncommon, 0% - 3.5%									x		x	x	x
Erectile dysfunction	Erectile dysfunction	rare, 0.2% - 1.6%		x	x	x	x	x	x	x			x	x	x
Arrhythmia	Arrhythmia	rare							x	x					x
Chest pain	Chest pain	rare	x	x	x	x	x	x	x	x			x	x	x
Osteoarthritis	Dysarthria	rare		x	x	x	x	x	x	x		x
Dysgeusia	Dysgeusia	rare							x	x
Dyskinesia	Dyskinesia	rare							x	x
Haematuria	Haematuria	rare		x	x	x	x	x	x	x			x	x	x
Nasal congestion	Nasal congestion	rare	x	x	x	x	x	x	x	x
Nocturia	Nocturia	rare		x	x	x	x	x	x	x
Palpitations	Palpitations	rare	x	x	x	x	x	x	x	x			x	x	x
Shock	Syncope	rare	x	x	x	x	x	x	x	x			x	x	x
Syncope	Syncope	rare	x	x	x	x	x	x	x	x			x	x	x
Loss of consciousness	Syncope	rare	x	x	x	x	x	x	x	x			x	x	x
Loss of consciousness	Loss of consciousness														x
Weight increased	Weight increased	rare	x	x	x	x	x	x	x	x
Hepatic function abnormal	Hepatic function abnormal	rare								x
Drug withdrawal syndrome	Withdrawal symptom	rare									x	x
Drug withdrawal syndrome	Drug withdrawal syndrome								x	x
Abdominal pain	Abdominal colic	rare							x	x
Abdominal pain	Abdominal pain			x	x	x	x	x					x	x	x
Oedema peripheral	Ankle edema	rare	x	x	x	x	x	x	x	x
Oedema peripheral	Oedema peripheral	common, 0% - 3.33%									x	x	x	x	x
Joint swelling	Ankle edema	rare	x	x	x	x	x	x	x	x
Body temperature decreased	Body temperature decreased	very rare, uncommon							x	x	x	x	x	x	x
Hypothermia	Body temperature decreased	very rare, uncommon							x	x	x	x	x	x	x
Gastrointestinal pain	Abdominal pain			x	x	x	x	x					x	x	x
Albuminuria	Albuminuria												x	x	x
Anaemia	Anaemia												x	x	x
Apnoea	Apnoea												x	x	x
Mental disorder	Mental disorder								x	x		x
Breast disorder	Breast disorder									x		x
Neoplasm malignant	Carcinoma												x	x	x
Infection	Infection												x	x	x
Connective tissue disorder	Connective tissue disorder											x
Depression	Depression	common, 0% - 1.6%										x	x	x	x
Dermatitis contact	Dermatitis contact												x	x	x
Oedema	Oedema										x
Eye disorder	Eye disorder									x		x
Faecal incontinence	Faecal incontinence												x	x	x
Flatulence	Flatulence												x	x	x
Gastroenteritis	Gastroenteritis												x	x	x
Gastrointestinal haemorrhage	Gastrointestinal haemorrhage												x	x	x
Cardiac disorder	Cardiac disorder									x		x
Hyperglycaemia	Hyperglycaemia												x	x	x
Hyperventilation	Hyperventilation												x	x	x
Orthostatic hypotension	Orthostatic hypotension												x	x	x
Conversion disorder	Hysteria												x	x	x
Influenza	Influenza												x	x	x
Nephrolithiasis	Calculus of kidney												x	x	x
Leukocytosis	Leukocytosis												x	x	x
Mediastinal disorder	Mediastinal disorder											x
Meningitis	Meningitis												x	x	x
Miosis	Miosis			x	x	x	x	x
Mydriasis	Mydriasis			x	x	x	x	x
Nervous system disorder	Nervous system disorder									x		x
Oliguria	Oliguria												x	x	x
Personality disorder	Personality disorder												x	x	x
Petechiae	Petechiae												x	x	x
Pneumonia aspiration	Pneumonia aspiration												x	x	x
Pulmonary embolism	Pulmonary embolism												x	x	x
Renal failure	Renal failure												x	x	x
Rhinitis	Rhinitis												x	x	x
Skin ulcer	Skin ulcer												x	x	x
Cerebrovascular accident	Cerebrovascular accident								x	x			x	x	x
Completed suicide	Suicide												x	x	x
Swelling	Swelling										x
Tachycardia	Tachycardia												x	x	x
Thrombophlebitis	Thrombophlebitis												x	x	x
Tongue disorder	Tongue disorder												x	x	x
Urethral disorder	Urinary tract disorder									x		x
Urinary tract disorder	Urinary tract disorder									x		x
Vaginal inflammation	Vaginal inflammation												x	x	x
Vaginal infection	Vaginal inflammation												x	x	x
Angiopathy	Angiopathy									x		x
Ventricular arrhythmia	Ventricular arrhythmia												x	x	x
Mood swings	Mood swings												x	x	x
Affect lability	Mood swings												x	x	x
Photophobia	Photophobia												x	x	x
Musculoskeletal stiffness	Neck stiffness												x	x	x
Nuchal rigidity	Neck stiffness												x	x	x
Drug ineffective	Lack of drug effect												x	x	x
Opisthotonus	Opisthotonus												x	x	x
Blood alkaline phosphatase increased	Phosphatase alkaline increased		x		x	x	x	x
Hyporeflexia	Hyporeflexia												x	x	x
Aspartate aminotransferase increased	Aspartate aminotransferase increased		x		x	x	x	x	x
Malnutrition	Malnutrition											x	x	x	x
Skin disorder	Unspecified disorder of skin and subcutaneous tissue								x	x		x
Malaise	Malaise												x	x	x
Discomfort	Malaise												x	x	x
Ill-defined disorder	Malaise												x	x	x
Muscle twitching	Muscle twitching												x	x	x
Wound dehiscence	Wound dehiscence												x	x	x
Hepatobiliary disease	Hepatobiliary disease								x	x
Major depression	Psychotic depression												x	x	x
Akathisia	Akathisia												x	x	x
Coordination abnormal	Coordination abnormal			x	x	x	x	x					x	x	x
Face oedema	Face oedema												x	x	x
Gait disturbance	Gait disturbance												x	x	x
Cerebral ischaemia	Cerebral ischaemia												x	x	x
Haematochezia	Blood in stool			x	x	x	x	x
Ageusia	Ageusia												x	x	x
Ejaculation disorder	Abnormal ejaculation												x	x	x

Indication	Labels
Bladder dysfunction							x	x
Brain disorder NOS							x	x
Brain injury											x		x
Cerebral palsy											x	x	x
Cerebrovascular disorder							x	x
Clonus	x			x	x	x
Epilepsy							x	x
Head injury											x	x	x
Hypertonia							x	x
Multiple sclerosis	x	x		x	x	x	x	x	x	x	x		x
Muscle rigidity	x			x	x	x
Muscle spasms	x		x	x	x	x	x	x			x		x
Muscle spasticity	x	x	x	x	x	x			x	x	x	x	x
Pain	x			x	x	x
Respiratory depression													x
Spinal cord disorder	x	x		x	x	x			x	x
Spinal cord injury	x	x		x	x	x					x		x
Traumatic brain injury											x	x	x

Side effects:	23
Source:	FDA Structured Product Label

Side effects:	50
Source:	Health Canada

Side effects:	52
Source:	FDA Structured Product Label

Side effects:	52
Source:	FDA Structured Product Label

Search results :

Baclofen

Side effects

Indications

BACLOFEN

BACLOFEN / PHL-BACLOFEN

Baclofen

baclofen

Baclofen

BACLOFEN / KEMSTRO

Baclofen / BACLOFEN TABLETS

Baclofen / Clofen

baclofen / LIORESAL

LIORESAL INTRATHECAL / Lioresal Intrathecal, Solution for injection

baclofen

BACLOFEN

baclofen injection / LIORESAL INTRATHECAL

Color scheme:

		100%
		75%
		50%
		10%
		frequent (1% to 100%)
		infrequent (0.1% to 1%)
		rare (<0.1%)
		postmarketing
		0%
		no frequency information
		not found on label