PRAMIPEXOLE

N/A

Manufactured by Camber Pharmaceuticals, Inc.

35,207 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PRAMIPEXOLE

PRAMIPEXOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Camber Pharmaceuticals, Inc.. The most commonly reported adverse reactions for PRAMIPEXOLE include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PRAMIPEXOLE.

Top Adverse Reactions

DRUG INEFFECTIVE1,349 reports
FALL1,066 reports
FATIGUE1,043 reports
NAUSEA832 reports
PAIN795 reports
CONDITION AGGRAVATED788 reports
HALLUCINATION754 reports
OFF LABEL USE737 reports
DIZZINESS734 reports
DYSPNOEA710 reports
DYSKINESIA644 reports
GAIT DISTURBANCE642 reports
HEADACHE593 reports
TREMOR576 reports
DEATH565 reports
INSOMNIA563 reports
ASTHENIA533 reports
SOMNOLENCE518 reports
ARTHRALGIA512 reports
PNEUMONIA501 reports
ANXIETY486 reports
DIARRHOEA474 reports
CONSTIPATION452 reports
VOMITING445 reports
COUGH443 reports
RESTLESS LEGS SYNDROME439 reports
CONFUSIONAL STATE414 reports
MALAISE412 reports
PAIN IN EXTREMITY408 reports
MEMORY IMPAIRMENT399 reports
PERIPHERAL SWELLING395 reports
WEIGHT DECREASED392 reports
DEPRESSION390 reports
BALANCE DISORDER372 reports
HYPERTENSION368 reports
PARKINSON^S DISEASE365 reports
DRUG INTERACTION346 reports
PRODUCT DOSE OMISSION ISSUE346 reports
FEELING ABNORMAL338 reports
URINARY TRACT INFECTION338 reports
ABDOMINAL PAIN326 reports
GENERAL PHYSICAL HEALTH DETERIORATION320 reports
HYPOTENSION320 reports
BACK PAIN318 reports
OEDEMA PERIPHERAL318 reports
ON AND OFF PHENOMENON312 reports
MUSCULOSKELETAL STIFFNESS307 reports
HALLUCINATION, VISUAL288 reports
RASH288 reports
ANAEMIA268 reports
WEIGHT INCREASED267 reports
PRURITUS266 reports
MUSCLE SPASMS256 reports
PYREXIA254 reports
DRUG HYPERSENSITIVITY248 reports
DECREASED APPETITE243 reports
ACUTE KIDNEY INJURY240 reports
MOBILITY DECREASED236 reports
HYPOAESTHESIA228 reports
PRODUCT USE IN UNAPPROVED INDICATION225 reports
THERAPEUTIC PRODUCT EFFECT INCOMPLETE225 reports
SUICIDAL IDEATION219 reports
FREEZING PHENOMENON217 reports
JOINT SWELLING217 reports
PRODUCT USE ISSUE206 reports
ABDOMINAL PAIN UPPER204 reports
CHRONIC KIDNEY DISEASE200 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES199 reports
MUSCULAR WEAKNESS198 reports
MUSCLE RIGIDITY195 reports
RENAL FAILURE191 reports
COVID 19189 reports
NASOPHARYNGITIS188 reports
ARTHRITIS187 reports
ASTHMA187 reports
BLOOD PRESSURE INCREASED185 reports
IMPULSE CONTROL DISORDER183 reports
AGITATION180 reports
ERYTHEMA178 reports
SLEEP DISORDER176 reports
DEVICE ISSUE174 reports
INFUSION RELATED REACTION173 reports
RHEUMATOID ARTHRITIS173 reports
COGNITIVE DISORDER171 reports
PARAESTHESIA169 reports
SPEECH DISORDER169 reports
ABDOMINAL DISCOMFORT168 reports
DYSPHAGIA167 reports
DYSTONIA167 reports
HYPERHIDROSIS167 reports
ALOPECIA166 reports
MEDICATION ERROR162 reports
UNEVALUABLE EVENT160 reports
BLOOD CREATININE INCREASED159 reports
LOSS OF CONSCIOUSNESS158 reports
THERAPEUTIC PRODUCT EFFECT DECREASED158 reports
PULMONARY FIBROSIS156 reports
HYPERSENSITIVITY155 reports
DRUG INTOLERANCE153 reports
THERAPEUTIC RESPONSE SHORTENED153 reports

Report Outcomes

Out of 14,398 classified reports for PRAMIPEXOLE:

Serious 74.0%Non-Serious 26.0%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Female8,047 (60.9%)
Male5,146 (38.9%)
Unknown21 (0.2%)

Reports by Age

Age 65363 reports
Age 67349 reports
Age 78345 reports
Age 70343 reports
Age 69340 reports
Age 74328 reports
Age 71325 reports
Age 73323 reports
Age 75307 reports
Age 72292 reports
Age 76289 reports
Age 79278 reports
Age 62270 reports
Age 77263 reports
Age 68258 reports
Age 66253 reports
Age 63247 reports
Age 61237 reports
Age 64224 reports
Age 80210 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with PRAMIPEXOLE?

This profile reflects 35,207 FDA FAERS reports that mention PRAMIPEXOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PRAMIPEXOLE?

Frequently reported terms in FAERS include DRUG INEFFECTIVE, FALL, FATIGUE, NAUSEA, PAIN, CONDITION AGGRAVATED. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PRAMIPEXOLE?

Labeling and FAERS entries often list Camber Pharmaceuticals, Inc. in connection with PRAMIPEXOLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.